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).
- Conditions
- Gut Dysbiosis
- Registration Number
- NCT06572358
- Lead Sponsor
- NovoBliss Research Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age: 18 to 65 years (both inclusive) at the time of consent.<br><br> 2. Sex: Healthy males and healthy non-pregnant/non-lactating females.<br><br> 3. Females of childbearing potential must have a self-reported negative pregnancy test.<br><br> 4. Subject should have refrigerator at their home for storage of test product.<br><br> 5. Subjects having history of falling sick frequently in two months.<br><br> 6. Subjects having gut dysbiosis with either of these three symptoms which includes<br> burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching<br> joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea<br> etc.<br><br> 7. If the subject is of childbearing potential, is practicing and agrees to maintain an<br> established method of birth control (IUD, hormonal implant device/injection, regular<br> use of birth control pills or patch, diaphragm, condoms with spermicide or sponge<br> with spermicidal jelly, cream or foam, partner vasectomy or abstinence).<br><br> 8. Subjects are willing to give written informed consent and are willing to come for<br> regular follow-up.<br><br> 9. Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated<br> treatments or food having high probiotics other than the test product for the entire<br> duration of the study.<br><br> 10. Subject who has not participated in a similar investigation in the past three<br> months.<br><br> 11. Willing to use test product throughout the study period.<br><br>Exclusion Criteria:<br><br> 1. Subject with suspected or proved organic causes of constipation, such as<br> Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.<br><br> 2. Subject with present condition of allergic response to any probiotic product.<br><br> 3. Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories,<br> anti-histamines, corticotherapy etc.) that might influence the outcome of the study.<br><br> 4. Subjects with any major diseases of the cardiovascular, renal, hepatic,<br> gastrointestinal, pulmonary or endocrine systems.<br><br> 5. History of alcohol or drug addiction.<br><br> 6. Subjects with a history of major gastrointestinal complications (i.e. Crohn's<br> disease, ulcer, cancer, ulcerative colitis).<br><br> 7. Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection<br> medication, rheumatoid arthritis).<br><br> 8. Pregnant or breastfeeding or planning to become pregnant during the study period.<br><br> 9. Subjects participating in other similar product or therapeutic trials within the<br> last four weeks.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method