CTRI/2025/01/079362
Recruiting
Phase 3 4
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
Vedic Lifesciences Pvt. Ltd6 sites in 1 country126 target enrollmentStarted: January 25, 2025Last updated:
Overview
- Phase
- Phase 3 4
- Status
- Recruiting
- Sponsor
- Vedic Lifesciences Pvt. Ltd
- Enrollment
- 126
- Locations
- 6
- Primary Endpoint
- To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per week
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Participants agreed to the signed and dated informed consent form.
- •2.Male and female individuals of age between 18 to 60 years.
- •3.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: i.Must include two or more of the following criteria: a)Fewer than three SBMs per week b) Straining during more than ¼ (25%) of defecations c) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations d) Sensation of incomplete evacuation more than ¼ (25%) of defecations e) Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations f) Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) ii.Loose stools are rarely present without the use of laxatives iii.
- •Insufficient criteria for irritable bowel syndrome
- •Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
- •Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
- •Individuals with fewer than three CSBMs per week.
Exclusion Criteria
- •Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
- •Individuals with anorectal pathology.
- •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.
- •5.Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
- •6.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.
- •Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening.
- •Opioids-induced constipation.
Outcomes
Primary Outcomes
To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per week
Time Frame: from baseline to the end of study visit.
Secondary Outcomes
- To assess the effect of Investigational product (IP) in comparison to baseline & placebo on stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.(from baseline to the end of study visit)
- To assess the effect of Investigational product (IP) in comparison Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM)(from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.)
- To assess the effect of Investigational product (IP) in comparison Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)(from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.)
- To assess the effect of Investigational product (IP) in comparison to Percentage responders defined as the number of participants with an increase by 1 or more frequencies of SBM with no sensation of incomplete evacuation(from baseline to the end of intervention)
- To assess the effect of Investigational product (IP) in comparison Gut microbiome (alpha & beta diversity)(from baseline to end of intervention)
- To assess the effect of Investigational product (IP) in comparison Difference in the usage of rescue medication(throughout the study duration as compared to placebo)
Investigators
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
Study Sites (6)
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