NCT06687720

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

A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Management of Irritable Bowel Syndrome: A Randomized, Open Label, Placebo-Arm, Comparative, Interventional, Proof-of-Science Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study. Subjectsshall be instructed to visit the facility for the following scheduled visits: * Visit 01 \[Within 30 days\]: Screening, Blood Parameter Assessment. * Visit 02 \[Day 01\]: Enrolment, Evaluations, Treatment Dispensing. * Visit 03 \[Day 15 (±2 days)\]: Telephonic follow-up. * Visit 04 \[Day 30 (±2 days)\]: Treatment End, Final Evaluations.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	MetBroma	Mode of Usage: Take one slow-release capsule twice a day, after meal Dosage Form: Capsule Unit Dose Route of administration: Oral frequency: Twice a day

Timeline

• Start date: 2024-11-30
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2024-11-14
• Last updated: 2024-11-14