Cedex, Israel

Oral Helicobacter Pylori Eradication

Inclusion criteria: oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled. Exclusion criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study. Written informed consent was obtained from all patients prior to participation in the study.

Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection

Background: Bismuth quadruple therapy is currently the recommended first-line regimen for Helicobacter pylori (H. pylori) infection in regions with high clarithromycin resistance. Recent randomized trials showed that 7-day vonoprazan-based triple therapy is superior to 7-day lansoprazole-based triple therapy in Japanese. A recent trial further showed that 7-day vonoprazan-based high dose amoxicillin dual therapy was non-inferior to 7-day vonoprazan-based triple therapy in Japanese. However, whether vonoprazan based dual, triple, and quadruple therapies are superior or non-inferior to lansoprazole based triple or quadruple therapy remains unknown. Objective: The investigators aimed to compare the efficacy and safety of 14-day vonoprazan-based dual therapy, triple therapy, bismuth quadruple therapy, reverse hybrid therapy, and lansoprazole-based bismuth quadruple therapy and triple therapy in the first-line treatment of H. pylori infection in this pilot study. The long-term changes in gut microbiota, antibiotic resistance, trimethylamine-N-oxide (TMAO) levels, and metabolic parameters after eradication therapies will also be investigated. Methods: Using a block randomization with a block size of 16 in a 1:1 ratio, 1200 eligible adult subjects aged 20 years or greater with at least two positive tests for H. pylori infection will be randomized to receive one of the following regimens: (A) vonoprazan-based triple therapy for 14 days (T-V14): vonoprazan 20mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 14 days ; or (B) vonoprazan-based triple therapy for 7 days (T-V7): vonoprazan 20mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 7 days ; or (C): vonoprazan-based dual therapy for 14 days (D-V14): vonoprazan 20mg twice daily, amoxicillin 750mg every 8 hour for 14 days; (D): vonoprazan-based high dose dual therapy for 14 days (HD-V14): vonoprazan 20mg twice daily, amoxicillin 750mg four times a day for 14 days; or (E) vonoprazan-based bismuth quadruple therapy for 14 days (BQ-V14) vonoprazan 20mg twice daily, bismuth tripotassium dicitrate 300 mg three times a day, tetracycline 500mg three times a day, and metronidazole 500mg three times a day for 14 days; or (F) vonoprazan-based reverse hybrid therapy for 14 days (RH-V14): vonoprazan 20mg twice daily, and amoxicillin 1000mg twice daily for 14 days, plus clarithromycin-XL 500mg twice daily and metronidazole 500mg twice daily for the first 7 days ; or (G) lansoprazole-based bismuth quadruple therapy for 14 days (BQ-L14) lansoprazole 30mg twice daily, bismuth tripotassium dicitrate 300 mg three times a day, tetracycline 500mg three times a day, and metronidazole 500mg three times a day for 14 days; or (H) lansoprazole-based triple therapy for 14 days (T-L14): lansoprazole 30mg twice daily, clarithromycin-XL 500mg twice daily, amoxicillin 1000mg twice daily for 14 days. Subjects who fail after first-line therapy will be randomized to receive either vonoprazan-based levofloxacin triple therapy (LT-V14) containing vonoprazan 20mg twice daily, levofloxacin 250mg twice daily, and amoxicillin 1000mg twice daily for 14 days or vonoprazan-based levofloxacin reverse hybrid therapy (LRH-V14) containing vonoprazan 20mg twice daily, and amoxicillin 1000mg twice daily for 14 days, plus levofloxacin 250mg twice daily and metronidazole 500mg twice daily for the first 7 days. The minimum inhibitory concentrations will be determined by agar dilution test. 23S ribosomal RNA and gyrase A mutations will be determined by PCR methods followed by direct sequencing in a subgroup of patients. The TWB2.0 SNP array will be used for genotyping of genome wide single nucleotide polymorphism. Fecal and oral samples will be collected for 16S and shot-gun sequencing at baseline, week 2, week 8, year 1, and year 2. Metabolic parameters will be measured at baseline, week 8, year 1, and year 2. Modified carnitine challenge test (mCCT) will be done to assess the production of urine TMAO at baseline, week 2, week 8, year 1, and year 2 in a subgroup of study subjects. Outcome analysis: The primary outcome is the eradication rate in the first-line treatment. The secondary outcomes are the compliance, frequency of adverse events, the overall eradication rate after two treatments. The long-term outcomes are the cumulative eradication rate, the changes of gut microbiota, antibiotic resistance, TMAO production, and metabolic parameters at year 1 and year 2.

European Registry on the Management of Helicobacter Pylori Infection

Abstract Introduction: H. pylori selectively infects the human stomach mucosa, being the most prevalent chronic infection in the world. Its prevalence correlates with socioeconomic factors and it is higher in older individuals. H. pylori presence causes chronic gastritis in 100% of infected patients and is the major cause of relevant diseases such as atrophic gastritis, peptic ulcer disease and gastric cancer; it is for this reason that from a public health standpoint it is considered a high impact pathogen, responsible of a significant morbidity and mortality. Nowadays there are Consensus and Clinical Guidelines regarding the infection management at a European level and in most of the states, but no data have shown the level of implementation of these recommendations. The high costs that this infection carries both socially and to the health system require the continuous and systematic assessment of the diagnostic and treatment strategies, as well as the accessibility to diagnostic methods and most efficient drugs. Aim: To register the treatment, diagnosis and management strategies of H. pylori infected adult patients in the Digestive Services outpatient clinics throughout Europe. Methods: Non-interventionist prospective multicentre international registry promoted by the European Helicobacter Study Group. A renowned gastroenterologist from each country was selected as Local Coordinator (30 countries). They will in turn select up to ten gastroenterologists per country that will register the routine clinical practice consultations they receive over 10 years in an electronic Case Report Form (e-CRF). Variables retrieved will include clinical, diagnostic, treatment, eradication confirmation and outcome data. The database will allow researchers to perform specific subanalysis after approval by the Scientific Committee of the study. INTRODUCTION H. pylori presence causes chronic gastritis in 100% of infected patients and is the major cause of relevant diseases such as atrophic gastritis, peptic ulcer disease and gastric cancer. H. pylori eradication prevents peptic ulcer recurrence and its complications, and decreases the incidence of gastric cancer. H. pylori eradication in patients with peptic ulcer or even functional or non-investigated dyspepsia is a cost-effective strategy. The most common clinical manifestation of H. pylori infection is dyspepsia, a major health problem, whose prevalence reaches more than 10% among adult populations with its attendant burden of morbidity and health system costs in diagnosis and treatment. Approximately 20% to 30% of people in the community each year report chronic or recurrent dyspeptic symptoms, and consultations for dyspepsia account for up to 40% of referrals among gastroenterology outpatients, the "test-and-treat" strategy being the most cost-effective. Moreover, H. pylori is the major cause of peptic ulcer disease, causing over 90% of duodenal and 70% of gastric ulcers. Considerable evidence supports that the nature of the chronic inflammatory process driven by H. pylori is of critical importance in gastric carcinogenesis (adenocarcinoma and mucosa-associated lymphoid tissue -MALT- lymphoma). It is for that reason that the WHO's International Agency for Research on Cancer classified H. pylori as a group 1 (definite) carcinogen. Scientific evidence demonstrates that diagnosis and eradication of H. pylori is the most cost-effective strategy in the management of dyspepsia, peptic ulcer and gastric cancer prevention. The treatment regimens are very diverse and have changed overtime. Monotherapies and treatments with two drugs did not achieve acceptable eradication rates. The commonly recommended regimen in most Consensus Conferences is the standard triple regimen, combining two antibiotics (clarithromycin with amoxicillin or metronidazole) and a proton pump inhibitor (PPI) for 7 to 14 days. Another recommended alternative is bismuth-containing quadruple therapy (PPI, tetracycline, metronidazole and bismuth salts). In the last years, results with new and efficient rescue regimens including levofloxacin have been published. Lately, new treatments have been proposed, including non-bismuth quadruple regimens, with two main variants: the "sequential" treatment (an induction phase with PPI and amoxicillin and a second phase with PPI, clarithromycin and metronidazole) and the "concomitant" treatment (same four drugs taken altogether). The great diversity of regimens and treatment lines, the different efficacy of these, mostly due to the increase in bacterial antibiotic resistance and regional differences, requires a continuous critical analysis of clinical practice, evaluating systematically the efficacy and safety of the different regimens and the cost-effectiveness of the different diagnostic-therapeutic strategies. This will help in the design of an efficient and optimized treatment that will reduce number of re-treatments, diagnostic tests and the appearance of associated pathologies such as peptic ulcers, gastrointestinal bleeding and, probably, gastric cancers. Therefore, the evaluation of real clinical practice using non-interventionist registries will help to improve the design and organization of European Consensus on the management of H. pylori infection, which is the best way to establish healthcare efficiency. AIMS Primary aim To obtain a database registering systematically over a year a large and representative sample of routine clinical practice of European gastroenterologists in order to produce descriptive studies of the management of H. pylori infection. Secondary aims 1. To evaluate H. pylori infection consensus and clinical guidelines implementation in different countries. 2. To perform studies focused on epidemiology, efficacy and safety of the commonly used treatments to eradicate H. pylori. 3. To evaluate accessibility to healthcare technologies and drugs used in the management of H. pylori infection. 4. To allow the development of partial and specific analysis by the participating researchers after approval by the Registry's Scientific Committee. METHODS International multicenter prospective non-interventionist registry promoted by the European Helicobacter Study Group. Scientific Committee - Javier P. Gisbert (President) - Francis Megraud - Colm O'Morain - Adrian G. McNicholl Local Coordinators A list of European Countries has been selected. Included countries were those having at least ten clinical research publications in PubMed regarding H. pylori infection. In each country a Local Coordinator was selected based on its clinical and research activity (Table I). The Local Coordinators will constitute the monitoring and drafting committee of the registry. The Local Coordinators will be in charge of selecting up to 10 recruiting investigators in each country and will be in charge of the follow up and quality of the recruiting; they will be the link between promoters and recruiting investigators. Recruiter Investigators The Recruiting Investigators must be gastroenterologists attending an adult population with a gastroenterology outpatient clinic that assists H. pylori infected patients. Before acceptance the outpatient clinic must attend, in a clinical routine basis, patients in which H. pylori diagnosis or treatment is indicated. Eradication confirmation tests have to be performed routinely. They will register the study variables of their own routine clinical practice in an e-CRF. Study Variables Anonymised Patient Identifiers - Country/Centre/Investigator - Autonumeric Patient identifier number - Gender - Date of Birth - Ethnic Background History and Comorbidity - Drug allergies - Relevant comorbidities - Current concomitant medication Data on Infection - Indication for diagnosis and treatment - Upper Gastrointestinal tract symptoms - Diagnostic Test for current treatment - Number and type of previous eradication attempts Prescribed Treatment - Drugs - Dosage and intakes per day - Length of treatment Compliance - Adherence to treatment (yes/no >90%) Adverse Events - Type of event, intensity, duration and relation with treatment - Treatment withdrawal due to adverse events. Efficacy - Eradication (yes/no), test used, and date

A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome

A Trial to Assess Gastrointestinal Responses to Dietary Fibers in Adults Using Weight Loss Medications

Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function

1. Total number of subjects who will be approached (including screen fails, controls, and subject withdrawals) to reach enrollment numbers for the lifetime of the study for this investigator's site: 100-125 2. Total number of subjects to be enrolled at this site: The investigators plan to enroll 60 participants for a target completion of 50 participants (25/arm). Enrolling 60 individuals allows for a conservative 20% attrition rate. This is the first human study of the commercial product Tetrasol, which looks at intestinal health outcomes. Therefore, this will be considered a pilot study, and the data will allow us to determine the appropriate sample size for a statistically powered study to identify differences in gastrointestinal health between Tetrasol consumers and placebo. 3. Brief Description/justification for the proposed sample size in lay terms: The investigators have no human data related to our primary outcome measures for this product. Therefore, investigators propose a pilot study of 25 individuals in each study group. 4. Before the start of enrollment, 60 subjects will be randomly assigned using a random number generator. Upon enrollment, each subject will be assigned either intervention A or B, according to the randomization chart. 5. The study will be a double-blind, placebo-controlled study. Neither the investigators nor the participants will have knowledge of the contents of the capsules. The capsules will be labeled by Microphyt personnel who are not directly involved in the study, and they will maintain the code. Unlike the intervention capsules, the placebo does not contain rapeseed oil and calcium, as the product manufacturer developed these formulations. They wished to keep the placebo formula the same as the formula previously used in their in vitro assays and other clinical work for more equitable comparisons across studies. CSU clinical personnel will administer the two intervention capsules to the subjects according to the randomization strategy and will not be provided with the code for intervention groups until after all data analysis has been completed. In a very unlikely case of a severe adverse event (which is an event that requires the subject's hospitalization), the medical personnel will be provided information about the content of the capsules taken by the participant directly by the Microphyt personnel. The code will not be broken to the investigators until after all data has been analyzed and submitted as a preliminary report. A. Recruitment: Recruitment advertisements will be placed in the Coloradoan and other newspapers/newsletters as relevant and will be sent out electronically through the CSU faculty and administrative professionals list on the CSU State Classified list. The investigators will reach out to graduate students and undergraduates by sending the recruitment email to the appropriate administrative personnel in each department (i.e., Grad coordinators and academic success coordinators) and have them forward the study information to their students. Flyers will be posted and distributed throughout the CSU campus and at targeted locations within the community, including UC Health doctor's offices. Flyers will be sent out as direct mailers to individuals in the community; their names and addresses will be purchased from a reputable company that provides names and addresses of individuals in this age range (Alesco Data, http://www.alescodata.com/). To increase participant diversity, investigators will also reach out to student groups on campus, including the Adult Learner and Veterans Services, Asian Pacific American Cultural Center, Black/African American Cultural Center, El Centro, Native American Cultural Center, Pride Resource Center, and Women and Gender Advocacy Center, and cultural groups off campus such as the BIPOC Alliance. Finally, investigators will also contact individuals in our clinical database who participated in previous studies and indicated a willingness to be contacted for future studies. B. Screening Procedures or Interview/questionnaire: After a preliminary telephone screening (questionnaire attached), volunteers will undergo an in-person screening (visit 1) and provide written informed consent. A questionnaire will assess medical and health history and demographic information, followed by an anthropometric assessment (height, weight, waist, and hip circumferences). C. Informed consent process and timing of obtaining consent. Potential participants determined to be eligible through telephone screening will be emailed a copy of the consent form and asked to read it before their screening visit. At the screening visit, the study coordinator or other study personnel will review the consent form and encourage the participants to ask any questions about participation in the study. Study personnel conducting the consenting process will assess the ability of the individual to provide informed consent. They will also ensure that all participants know that consent can be withdrawn anytime. On the first visit (Screening, visit 1), after the participant receives a verbal and written explanation of the project and after the participant provides informed consent, investigators will assess the participant's medical and health history and dietary intake. The investigators will measure the participant's height, weight, and waist and hip circumferences. If the participant qualifies for our study, the participant will be scheduled for the second visit (Baseline, Visit 2). The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection prior to the next study visit. During the second visit (Baseline Visit, visit 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The participant will participate in the cold pressor test, which involves immersing the participant's hand in ice water for 2 and a half minutes while the participant's blood pressure is assessed. The investigators will provide the participants with daily dosing/treatment records and diet records, and the participants will complete sleep, physical activity, gastrointestinal, and mental health questionnaires. The investigators will perform a blood draw and collect the participant's saliva. The participant will then be scheduled for the participant's next appointment and given a 2-week supply of the participant's randomly assigned treatment capsules. This is a double-blind study, meaning neither the participant nor the investigators will know which treatment the participant has been assigned to take. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's third visit (Midpoint Visit, Visit/Week 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist and hip circumferences, supine blood pressure, and heart rate will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will then be scheduled for the participant's next appointment and given the participant's final allocation of the participant's assigned treatment capsules. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the final study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's fourth visit (Final Visit, visit 4, Week 4), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The participant will also be subjected to an acute stress test, during which the participant will alternate between placing the participant's hand in ice-cold water for 2 and a half minutes while the participant's blood pressure is assessed. This additional test is non-invasive, and the entire test (with an included instructional period) will last approximately 30 minutes. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will be provided with monetary compensation and will have completed the study.

H. Pylori Eradication With Argon Plasma During Endoscopy

Helicobacter pylori (H. pylori) is a prevalent bacterial infection that colonizes the gastric mucosa, affecting approximately 50% of the global population. Classified by the WHO as a class 1 carcinogen in 1994 and further supported by extensive evidence, H. pylori is recognized as a leading cause of ulcers and a significant risk factor for the development of gastric cancer. Despite a slight decline in the prevalence of H. pylori infection in developed countries, the absolute number of infected individuals in the U.S. remains alarmingly high at approximately 36% of the U.S. population. Gastric cancer, associated with H. pylori infection, continues to be a major health concern worldwide, accounting for over 1.1 million new cases and approximately 770,000 deaths each year. The causal link between H. pylori infection and nearly 90% of gastric cancer cases underscores the critical importance of effective eradication strategies. Current treatments for H. pylori infection, which typically consist of triple or quadruple therapy combining two or three antibiotics with proton pump inhibitors (PPIs), are successful in approximately 80% of cases. This leaves a significant proportion of cases unresolved. In addition, the emergence of multidrug-resistant H. pylori strains, particularly those resistant to clarithromycin and quinolones, challenges these conventional approaches. The broader issue of increasing antibiotic resistance, leads to a reliance on back-up antibiotics for cases where standard treatments fail. A sharp decline of eradication rates during the last decade, underscores the need for alternative therapeutic strategies. A recent study estimated the total cost of H. pylori treatment failure to be over $5.3 billion in the U.S., primarily due to hospitalizations, medications, and outpatient visits for complications such as peptic ulcer disease and non-cardia gastric cancer. Research into treatments beyond antibiotics is needed to address the growing risk of resistance and to ensure sustainable, effective solutions for H. pylori infection. The field of plasma medicine, particularly through the use of Argon Plasma Coagulation (APC), offers promising new avenues for addressing this challenge. APC, a technology with over 30 years of clinical safety and efficacy, has been utilized for bleeding management, ablation of cancerous tissues, and precise treatments in sensitive areas. More recently, it has shown good efficacy in the treatment of cervical intraepithelial lesions (CIN) at lower power levels with no visible macroscopic thermal effect. Recent advancements in plasma medicine have highlighted the antibacterial properties of physical plasma. It has demonstrated remarkable efficacy in wound healing by effectively eradicating bacterial infections, including those resistant to antibiotics. The effect of non-thermal plasma treatment is based on the high energy and voltage of the plasma, which generates reactive oxygen and nitrogen species (RONS), an electric field that can cause electroporative effects, and UV light emitted in the plasma. These effects are present when plasma is applied directly to the site of action, but also when a liquid medium such as sodium chloride solution is used as a buffer substance. This concept of indirect plasma treatment is often referred to as Plasma Activated Liquid (PAL). In proprietary preclinical studies, PAL generated with APC probes using forced APC Effect 8 has been shown to achieve a 5-log reduction in H. pylori (SK225) after 15 minutes incubation. In a multidrug resistant E. coli 4MRGN stain (VC8874), a 6-log reduction was achieved after 15 minutes incubation. This demonstrates that PAL harnesses the antimicrobial properties of plasma in a non-thermal, liquid-based approach. This innovative approach allows the effects of plasma to be applied to large surface areas, such as the gastric mucosa, offering a potentially effective treatment for H. pylori infection without the drawbacks associated with antibiotic resistance. The established safety record of APC and the common use of liquids as irrigation or injection solutions in endoscopy provide a solid foundation for its potential applications in the treatment of H. pylori infection.

Mechanisms of Gulf War Illness

Since 2001, more than 2.2 million US veterans have served in Operation Enduring Freedom (OEF) in Afghanistan and Operation Iraqi Freedom (OIF) in Iraq. The Gulf Registry of the VA Environmental Epidemiology Service identified the majority of these veterans as having chronic health complaints of undetermined etiology. Among the symptoms most frequently reported by veterans with Gulf War Illness (GWI) were chronic fatigue, frequent or persistent headache, frequent or persistent muscle or joint pain, and gastrointestinal (GI) symptoms. GI symptoms (e.g., diarrhea, bloating, and abdominal pain) reported by these veterans accounted for most complaints. Indeed, up to 33% of veterans with GWI suffer from chronic GI symptoms. The investigators have shown that veterans with GWI and GI symptoms have increased intestinal permeability that drives GI symptoms (Zhang et al., 2019). Our research group recently completed a clinical trial demonstrating the effectiveness of oral glutamine supplementation in diarrhea-predominant IBS patients with increased intestinal permeability (Zhou et al., 2019). The investigators now have obtained preliminary evidence that oral glutamine supplementation may restore intestinal permeability in veterans with GWI and GI symptoms. Based on these new findings, the investigators hypothesize that oral glutamine supplementation will improve the Symptom Severity Scale and restore intestinal permeability in veterans with GWI and chronic GI symptoms. The investigators propose to conduct a randomized, double-blind, placebo-controlled clinical trial studying oral glutamine supplementation compared to placebo in veterans with GWI and GI symptoms. The human GI tract is the major site of glutamine utilization in the body. Glutamine is a major energy source for rapidly dividing intestinal mucosal cells of the digestive tract. Glutamine helps to protect the lining of the GI tract. Its depletion results in epithelial atrophy and a subsequent increase in intestinal permeability. Glutamine supplementation has been shown to decrease bacterial translocation and intestinal permeability after intestinal injury. Glutamine supplementation has also been shown to decrease intestinal permeability and improve GI function in patients with Crohn's disease, advanced esophageal cancer, or metastatic cancer undergoing radio chemotherapy. There are no published studies to date to support the use of glutamine for veterans with GWI and chronic GI symptoms. However, given our published studies, preliminary data demonstrating restoration of intestinal permeability with oral glutamine therapy, and the mechanisms of action of glutamine on the GI tract, research testing whether oral glutamine is an effective therapy in veterans with GWI is needed. Given that there are no effective treatments for these veterans and that current treatment approaches are far from ideal, this proposed clinical trial would be extremely important as it would not only have a beneficial impact on the health of many of our veterans, but also it would substantially reduce the negative economic effects on the VA Health Care System.

Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder