A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functiona… (NCT06730594) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
India168 participantsStarted 2025-01-25
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Individuals agreed to the signed and dated informed consent form.
✓. Male and female individuals of age between 18 to 60 years (both values included)
✓. Individuals who meet Rome IV diagnostic criteria for functional constipation as indicated by the criteria fulfilled for the last 3 months with symptoms onset at least 6 months prior to diagnosis:
✓. Fewer than three SBMs per week
✓. Straining during more than ¼ (25%) of defecations
✓. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
✓. Sensation of incomplete evacuation more than ¼ (25%) of defecations
✓. Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
Exclusion criteria
✕. Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
What they're measuring
1
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.
✕. Individuals with history of gastrointestinal surgery including appendisectomy.
✕. Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator.
✕. Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
✕. Current pharmacological treatment related to constipation (e.g. prosecretory agents, antidepressants, antispasmodics, enterokinetic)
✕. Individuals consuming dietary treatment (e.g. synbiotics, herbal extracts, fibers) or taking other therapies for treating constipation (e.g. cognitive behavior therapy, acupuncture, biofeedback, complementary and alternative Medicine) within 1 month prior to screening.
✕. Use of antibiotics within 1 month prior to screening.