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, gut immunity).
- Conditions
- Health Condition 1: K599- Functional intestinal disorder, unspecified
- Registration Number
- CTRI/2024/08/071819
- Lead Sponsor
- Meteoric Biopharmaceuticals Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Age: 18 to 65 years (both inclusive) at the time of consent.
2)Sex: Healthy males and healthy non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative pregnancy test.
4)Subject should have refrigerator at their home for storage of test product.
5)Subjects having history of falling sick frequently in two months.
6)Subjects having elevated levels of CRP and IL-6 with symptoms of gut dysbiosis.
7)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.
8)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).
9)Subjects are willing to give written informed consent and are willing to come for regular follow-up.
10)Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
11)Subject who has not participated in a similar investigation in the past three months.
12)Willing to use test product throughout the study period.
1 Subject with suspected or proved organic causes of constipation, such as Hirschsprung disease, hypothyroidism, or structural anomalies of the anal canal.
2 Subject with present condition of allergic response to any probiotic product.
3 Subject under chronic medication aspirin based products, anti inflammatories, anti histamines, corticotherapy that might influence the outcome of the study.
4 Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
5 History of alcohol or drug addiction.
6 Subjects with a history of major gastrointestinal complications such as Crohn disease, ulcer, cancer, ulcerative colitis.
7 Subjects who have self reported immuno compromised HIV positive, on anti rejection medication, rheumatoid arthritis.
8 Pregnant or breastfeeding or planning to become pregnant during the study period.
9 Subjects participating in other similar product or therapeutic trials within the last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method