Phase
Condition
Bowel Dysfunction
Fecal Incontinence
Hyponatremia
Treatment
N/AClinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females aged 18 to 70 years.
- Participants with Irritable bowel syndrome (IBS) as per Rome IV IBS criteria: Recurrent abdominal pain on average at least 1 day/week in the last 3 months,associated with two or more of the following criteria:
- Related to defecation (Maybe increased or decreased by defecation)
- Associated with a change in the frequency of stool (increase in frequency)
- Associated with a change in the form (appearance) of stool
- History of abnormal bowel movements, which are predominantly diarrhea (more thanone-fourth (25%) of bowel movements with BSS Types 6-7 and less than one-fourth (25%)with BSS Types 1-2) in the last one month prior to screening.
- Average APS-NRS score of ≥ 6 for last 3 months prior to screening visit.
- Fasting blood glucose levels ≤ 125 mg/dL (6.94 mmol/l).
- Hemoglobin ≥ 10 g/dL.
- Able to comply and perform the procedures requested by the protocol (consumption ofstudy medications, filling scheduled eDiary for health updates, biological samplecollection procedures and study visit schedule).
- Participants with access to western toilet facilities.
- Participants with non-vegetarian dietary preferences (Note: Non-vegetarian food willbe defined as food derived from animals, birds, fish, shell-fish, etc)
- Participants consuming non-vegetarian food for at least 2 times in a week.
- SpO2 ≥ 96% as assessed by fingertip pulse oximetry
- Participants who are sufficiently literate to understand the essence of the study, areinformed about the purpose of the study, and understand their rights.
- Participants who are able to give written informed consent and are willing toparticipate in the study.
Exclusion
Exclusion Criteria:
- Participants not meeting IBS-D diagnostic criteria (i.e. IBS-Constipation, Mixed orUnclassified).
- Uncontrolled abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 μIU/mL.
- Uncontrolled Type II DM (Controlled Type II diabetics can be included uponinvestigator's discretion).
- Type I diabetes.
- Uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg.
- Use of probiotics and/or prebiotics (In the form of supplements) within the last 4weeks prior to screening.
- Use of medicines (Prescription, OTC, etc), health supplements or herbal medicinesexpected to promote gut health and alleviate IBS related complications within the lastfour 4 months prior to screening.
- Established diagnosis of Helicobacter pylori infection in last 3 months prior toscreening.
- History of surgical resection of the stomach, small intestine or large intestine.
- Participants with acute gastroenteritis.
- History or complications of inflammatory bowel disease (Crohn's disease or ulcerativecolitis) or ischemic colitis.
- Participants with complications from infectious enteritis.
- History of any diet-based intolerance (gluten or lactose intolerance).
- History of or complications from malignant tumors.
- History of any significant neurological or psychiatric condition which may affectstudy participation or inference of study outcomes.
- Consumption of psychotropic agents in the last 1 year prior to screening.
- History (in past 2 years) of smoking or currently smoking or using any form ofsmokeless tobacco.
- Participation in other clinical trials in last 90 days prior to screening.
- Participants with heavy alcohol consumption, defined as:
- For men: More than 14 standard alcoholic drinks (SAD)/week or more than 4 SAD ina day.
- For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standardalcoholic drink contains approximately 14 grams of alcohol, which is equivalentto 12 ounces of beer (
5% alcohol), 8.5 ounces of malt liquor (9% alcohol), 5ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry orport), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
- Participants who have a clinically active state of systemic illness, which may includebut is not limited to cardiovascular, endocrine, immune, respiratory, hepatobiliary,kidney and genitourinary, neuropsychiatric, and gastrointestinal system. To be ruledout by physician based on prior history and physical examination.
- 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
Study Description
Connect with a study center
Ahmedabad Gastro Associates,
Ahmedabad, Gujarat 380061
IndiaSite Not Available
Apex Gastro Clinic and Hospital,
Ahmedabad, Gujarat 380013.
IndiaSite Not Available
SN Gastro and Liver Clinic
Ahmedabad, Gujarat 380054
IndiaSite Not Available
Aman Hospital and research center
Vadodara, Gujarat -390021.
IndiaSite Not Available
Dr. Khanna Clinic,
Mumbai, Maharashtra 400059
IndiaSite Not Available
My Health Clinic,
Mumbai, Maharashtra 400059.
IndiaSite Not Available
Samarth Digestive Disease Centre
Mumbai, Maharashtra 400705,
IndiaSite Not Available
Stress Test Clinic
Mumbai, Maharashtra 400059
IndiaSite Not Available
Rahate Surgical Hospital,
Nagpur, Maharashtra 440008.
IndiaSite Not Available
Ashirwad Hospital And Research Centre,
Ulhasnagar, Maharashtra 421004
IndiaSite Not Available
Shubham Sudbhawana Superspeciality Hospital,
Varanasi, Uttar Pradesh 221005.
IndiaSite Not Available
Khannas Clinic
Varanasi ., Uttar Pradesh 221010
IndiaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.