A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Su… (NCT06572358) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation and Gut Immunity).
India14 participantsStarted 2024-10-22
Plain-language summary
This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).
Who can participate
Age range
18 Years – 65 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
. Age: 18 to 65 years (both inclusive) at the time of consent.
. Sex: Healthy males and healthy non-pregnant/non-lactating females.
. Females of childbearing potential must have a self-reported negative pregnancy test.
. Subject should have refrigerator at their home for storage of test product.
. Subjects having history of falling sick frequently in two months.
. Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
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
Changes in stool consistency based on the Bristol Stool Criteria
Timeframe: Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90
2
Change in faecal microbiota using 16s Metagenome sequencing
Timeframe: Baseline at Day 1, and on Day 90.
3
Abbreviated physical examinations in terms of frequency of sensation of defecation
Timeframe: Baseline Day 1, Day 45 and on Day 90
4
Abbreviated physical examinations in terms of bloating
Timeframe: Baseline Day 1, Day 45 and on Day 90
5
Abbreviated physical examinations in terms of nausea
Timeframe: Baseline Day 1, Day 45 and on Day 90
6
Abbreviated physical examinations in terms of altered bowel habit.
Timeframe: Baseline Day 1, Day 45 and on Day 90
7
Abbreviated physical examinations in terms of digestion issues
. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
. Subjects are willing to give written informed consent and are willing to come for regular follow-up.
Exclusion criteria
. Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
. Subject with present condition of allergic response to any probiotic product.
. Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
. Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
. History of alcohol or drug addiction.
. Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis).
. Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
. Pregnant or breastfeeding or planning to become pregnant during the study period.
Timeframe: Baseline Day 1, Day 45 and on Day 90
8
Abbreviated physical examinations in terms of aching joints
Timeframe: Baseline Day 1, Day 45 and on Day 90
9
Abbreviated physical examinations in terms of chronic fatigue
Timeframe: Baseline Day 1, Day 45 and on Day 90
10
Abbreviated physical examinations in terms of constipation for Frequency of bowel movements
Timeframe: Baseline Day 1, Day 45 and on Day 90
11
Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation
Timeframe: Baseline Day 1, Day 45 and on Day 90
12
Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt
Timeframe: Baseline Day 1, Day 45 and on Day 90
13
Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours
Timeframe: Baseline Day 1, Day 45 and on Day 90
14
Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort
Timeframe: Baseline Day 1, Day 45 and on Day 90
15
Abbreviated physical examinations in terms of constipation for Pain: abdominal pain
Timeframe: Baseline Day 1, Day 45 and on Day 90
16
Abbreviated physical examinations in terms of constipation for Assistance: type of assistance
Timeframe: Baseline Day 1, Day 45 and on Day 90
17
Abbreviated physical examinations in terms of constipation for History: duration of constipation (years)
Timeframe: Baseline Day 1, Day 45 and on Day 90
18
Abbreviated physical examinations in terms of diarrhoea