A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNovoBliss Research Pvt Ltd

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

18 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

NovoBliss Research Pvt Ltd

Lead sponsor

Meteoric Biopharmaceuticals Pvt. Ltd.

Collaborator