Status:
COMPLETED
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).
Lead Sponsor:
NovoBliss Research Pvt Ltd
Collaborating Sponsors:
Meteoric Biopharmaceuticals Pvt. Ltd.
Conditions:
Gut Dysbiosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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...
Detailed Description
A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Subject who has not participated in a similar investigation in the past three months.
- Willing to use test product throughout the study period.
Exclusion
- 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.
- Subjects participating in other similar product or therapeutic trials within the last four weeks.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06572358
Start Date
October 22 2024
End Date
February 7 2025
Last Update
March 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, India, 382481