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

NCT06730594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-03-19

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2026-03-14
Completion
2026-03-14

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730594 on ClinicalTrials.gov