A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the… (NCT06687720) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.
India18 participantsStarted 2024-11-30
Plain-language summary
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject is an adult male or female aged between 18 to 60 years old.
. Clinically diagnosed with irritable bowel syndrome (IBS) based on Rome IV criteria: Abdominal pain at least 4 days per month - over at least 2 months - associated with one or more of the following:
. The subject is having refrigerator at their home for storage of test treatment.
. The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
. The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
Exclusion criteria
. The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
. The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in Albumin/Globulin ratio
Timeframe: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
2
change in total serum protein
Timeframe: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
3
change in prealbumin levels
Timeframe: Baseline before and 6-8 hours post-dose on Day 01 and Day 30
4
Change in the lifestyle using the Scoring and Gradation
Timeframe: Day 01 (before administration) for baseline, and post-dose on Day 30.
5
Scoring and Gradation of symptoms of irritable bowel syndrome
Timeframe: Day 01 (before administration) for baseline, and post-dose on Day 30.
. The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
. The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
. The subject has a history of alcohol abuse.
. The subject is either pregnant, lactating, or plans on conceiving during the course of the study.
. The subject has participated in other clinical studies or received any investigational agent in the previous 30 days.
. The subject has other significant gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, celiac disease).