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 range18 Years – 65 Years
SexALL
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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.
✓. 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.
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
. 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.
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