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
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
• 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:
• i. Must include two or more of the following criteria:
⁃ 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
⁃ 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.