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KE, L-Lys-L-Glu, lysylglutamic acid

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Studies 40
Trials 100
Recruiting NA INTERVENTIONAL NCT06730594

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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

Interventions

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

Primary Outcomes

Measure: To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs)
TimeFrame: per week from baseline to the end of study visit.
Description: Severe constipation is defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥ 3.0 (CIC; 5-point scale) CSBM has emerged as an attractive symptom-specific primary endpoint for constipation trials, as it integrates the objective, quantitative sign of stool frequency and the subjective, qualitative symptom of sensation of complete defecation

Trial Information

NCT ID

NCT06730594

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Vedic Lifesciences Pvt. Ltd.

Last Updated

December 15, 2025