Clinical Trial: A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Functional Constipation
Study Type: INTERVENTIONAL
Official Title: 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
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…
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