Phase
Condition
N/ATreatment
TSH-GH-03
MK-GH-04
PA-GH-01
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female individuals with the age ≥18 and ≤65 years with moderate physicalactivity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Body mass index > 18 and < 29.9 kg/m2
Individuals with at least once/ week complains of ≥ 3 of following gastrointestinalsymptoms since last three months: dyspepsia, diarrhea, constipation, heartburn,nausea, acid reflux, bloating.
Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period
Individuals with fasting blood glucose levels ≤ 125 mg/dL
Individuals with availability of western toilet at their homes for stool samplecollection
Individuals who are literate enough to understand the essence of study, are informedabout the purpose of the study, and understand their rights.
Individuals who are able to give written informed consent and are willing toparticipate in the study.
Exclusion
Exclusion Criteria:
Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrheaor Unclassified
Allergy to aspirin
Use of medications in the last 2 weeks prior to the pre-baseline period. This doesnot include birth control pills or standard multi-vitamin/mineral supplements
Performing high intensity exercise regularly using IPAQ- SF
Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks priorto screening
Unwillingness to avoid the use of antidiarrheal or laxative medication on a regularor an "as-needed basis" during the full length of the study
Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.40 or > 4.50 μIU/mL
Individuals with uncontrolled type II DM defined as FBG > 125 mg/ dL
Presence of uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mmHg with or without anti-hypertensives
Individuals on high-fiber/ fodmap diet
Individuals with known diagnosis of helicobacter pylori infection
Individuals with a history of surgical resection of the stomach, small intestine orlarge intestine
Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis
Current smokers
Use of another investigational product within 3 months of the screening visit
History or current impaired cardiovascular circulation or uncontrolled hypertension,diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseasesincluding asthma, or any other disease, that by the investigators' discretion couldinterfere with the intestinal barrier function of the subject
Individuals who used probiotics, prebiotics, antibiotics, prokinetics, laxatives,suppositories or enemas in the last 3 months
Individuals with a history of any diet-based intolerance (gluten or lactoseintolerance)
Individuals with a history of or complications from malignant tumors.
History of any significant neurological and psychiatric condition which may affectthe participation and inference of the study's end points.
Use of recreational drugs (such as cocaine, methamphetamine, marijuana,etc.)/Nicotine dependence.
High-risk drinking as defined by consumption of 4 or more alcohol containingbeverages on any day or 8 or more alcohol containing beverages per week for womenand 5 or more alcohol containing beverages on any day or 15 or more alcoholcontaining beverages per week for men
Individuals who have clinically significant following illness, i.e., Cardiovascular,endocrine system, immune system, respiratory system, hepatobiliary system, kidneyand urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood andtumors, other gastrointestinal diseases, etc
Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives
Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.
Study Design
Connect with a study center
Dr. Kumta Mali's Clinic
Mumbai, Maharashtra 400053
IndiaSite Not Available
Dr. Preeti Bawaskar's Clinic
Thāne, Maharashtra 400607
IndiaSite Not Available

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