NCT06730594

A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with Functional constipation as compared to a placebo. Approximately 205 individuals aged between 18 and 60 years will be screened. Considering a screen failure of 20%, approximately 164 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 126 completed participants i.e. 63 partcipants in each study arm after accounting for a dropout/withdrawal rate of 23% at the end of the study. The intervention duration for all the study participants will be 56 days with follow up of upto 84 days. The study flow chart given below indicates the time points at which safety and efficacy assessments will be conducted

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VL-BK-02 (25 billion CFU/Capsule)	One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)
DIETARY_SUPPLEMENT	Placebo (Microcrystalline Cellulose - 375 mg/capsule)	One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)

Timeline

• Start date: 2025-01-25
• Primary completion: 2026-03-14
• Completion: 2026-03-14
• First posted: 2024-12-12
• Last updated: 2026-03-19

Locations

6 sites across 1 country: India