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

NCT06730594 | Completed DMC

• 1 other identifier: KE/240401/BK+/FC V.2
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 6

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

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs)

  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

  per week from baseline to the end of study visit.

Secondary Outcomes (6)

• To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.

  Baseline to Day 84

• To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM) from baseline to day 14, day 28, day 42, day 56, day 70 and day 84.

  Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.

• To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)

  Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.

• To assess the effect of Investigational product (IP) in comparison to baseline and placebo Percentage responders are defined as the number of participants with an increase by 1 or more frequencies of CSBM from baseline to the end of intervention.

  Baseline to Day 84

• To assess the effect of Investigational product (IP) in comparison to baseline and placebo in Gut microbiome (alpha and beta diversity) from baseline to end of intervention.

  Baseline to Day 84

Study Arms (2)

VL-BK-02 (25 billion CFU/Capsule)

EXPERIMENTAL

One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)

Dietary Supplement: VL-BK-02 (25 billion CFU/Capsule)

Placebo (Microcrystalline Cellulose - 375 mg/capsule)

PLACEBO COMPARATOR

One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)

Dietary Supplement: Placebo (Microcrystalline Cellulose - 375 mg/capsule)

Interventions

VL-BK-02 (25 billion CFU/Capsule) DIETARY_SUPPLEMENT

One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)

VL-BK-02 (25 billion CFU/Capsule)

Placebo (Microcrystalline Cellulose - 375 mg/capsule) DIETARY_SUPPLEMENT

One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)

Placebo (Microcrystalline Cellulose - 375 mg/capsule)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening
• Opioids-induced constipation.
• Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT- antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month prior to screening.
• Immuno-compromised participants.
• Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
• History of cancer .
• Individuals with known history of diabetes mellitus and are on medication for the same.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (6)

Anand Multispeciality Hospital

Vadodara, Gujarat, 390016, India

Location

AK Superspeciality Clinic

Pune, Maharashtra, 411014, India

Location

Gastrohub Hospital

Pune, Maharashtra, 411027, India

Location

Lifeline multispecialty Hospital

Pune, Maharashtra, 412101, India

Location

Care Multispecialty Hospital

Pune, Maharashtra, 412207, India

Location

Krishna Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

MeSH Terms

Interventions

microcrystalline cellulose

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment A randomized, double-blind, two-arm, placebo-controlled clinical study

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 12, 2024
• Study Start: January 25, 2025
• Primary Completion: March 14, 2026
• Study Completion: March 14, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)