About this trial
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Eligibility criteria
Qualifiers
The subject is an adult male or female aged between 18 to 60 years old.
The subject is having refrigerator at their home for storage of test treatment.
The subject is willing to provide written informed consent, comply with the study procedures, and be present for all the visits.
The subject is willing to abstain from using any other treatments for irritable bowel syndrome during the study period, unless for a medical urgency.
Disqualifiers
The subject has a history of diagnosis of either hypertension, diabetes, or liver disease.
The subject has any other significant medical condition that could interfere with the study or pose a risk to the participant.
The subject has used medications that could influence the study outcomes, such as antibiotics, immunosuppressive drugs, and probiotics or prebiotics supplements within the last 4 weeks.
The subject works in frequent night shifts (working night shifts at least 3 times per week), and refuses to change the lifestyle.
Trial design
Treatments tested in this trial
- MetBroma
Treatment groups
Locations
Sponsors and collaborators
NovoBliss Research Pvt Ltd
Lead sponsor
Meteoric Biopharmaceuticals Pvt. Ltd.
Collaborator