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

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

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: VL-BK-02 (25 billion CFU/Capsule); Dietary supplement: Placebo (Microcrystalline Cellulose - 375 mg/capsule)

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Vadodara, Gujarat, India, 390016
      • Anand Multispeciality Hospital
  • Maharashtra
    • Pune, Maharashtra, India, 411027
      • Gastrohub Hospital
    • Pune, Maharashtra, India, 411014
      • AK Superspeciality Clinic
    • Pune, Maharashtra, India, 412101
      • Lifeline multispecialty Hospital
    • Pune, Maharashtra, India, 412207
      • Care Multispecialty Hospital
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221005
      • Krishna Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Individuals agreed to the signed and dated informed consent form.
2. Male and female individuals of age between 18 to 60 years (both values included)

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:

   1. Fewer than three SBMs per week
   2. Straining during more than ¼ (25%) of defecations
   3. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
   4. Sensation of incomplete evacuation more than ¼ (25%) of defecations
   5. Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
   6. 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
4. Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
5. Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
6. Individuals with fewer than three CSBMs per week.

Exclusion Criteria:

1. Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
2. Individuals with anorectal pathology
3. Individuals with history of gastrointestinal surgery including appendisectomy.
4. 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)
7. 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.
8. Use of antibiotics within 1 month prior to screening.
9. Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening
10. Opioids-induced constipation.
11. 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.
12. Immuno-compromised participants.
13. Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
14. History of cancer .
15. Individuals with known history of diabetes mellitus and are on medication for the same.
16. Individuals suffereing from Diabetic gastroparesis.
17. History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
18. Individuals with impaired thyroid function reported by TSH less than 0.4 mIU/L and more than 5 mIU/L will be excluded. However, individuals on a stable dose of medication for past 6 months and within the aforementioned range, can be considered.
19. Psychiatric or behavioral disorders as judged by the Investigator
20. Individuals with known food allergy.
21. Individuals with eating disorders (e.g., anorexia, bulimia)
22. Pregnancy or lactation
23. Known allergic reactions to any components of the probiotics or placebo.
24. Individuals participating in other interventional study within 90 days prior to screening.
25. Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment.
26. Current Smokers.
27. Individuals with more than 14 SBMs per week.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VL-BK-02 (25 billion CFU/Capsule); One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)	Dietary supplement: VL-BK-02 (25 billion CFU/Capsule); One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)
Placebo Comparator: Placebo (Microcrystalline Cellulose - 375 mg/capsule); One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)	Dietary supplement: Placebo (Microcrystalline Cellulose - 375 mg/capsule); One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The PAC-QOL questionnaire is subcategorized into 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4.Higher scores mean higher negative effects on quality of life. Items	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 Stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.	The BSFS is a commonly used ordinal stool-type scale in clinical research and practice that goes from the hardest (type 1) to the softest (type 7). Abnormally hard stools (and in conjunction with other symptoms indicative of constipation) are referred to as types 1 and 2. On the other hand, types 6 and 7 are characterized by unusually loose or watery stools together with other symptoms that point to diarrhea. Stool forms 3-5 are regarded as the most "normal.	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.	Chronic constipation is a common, self-reported, symptom-based disorder, which can significantly impact an individual's health-related quality of life The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe', and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.	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.	Based on EMA guidelines, a CSBM weekly responder will be defined as a participant who experienced more than or equal to 3 CSBMs per week and an increase of ≥ 1 CSBM per week (compared to the baseline).46,47 A "sustained response" will be defined as fulfilling these criteria for the last 4 weeks of treatment.	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.	Stool samples will be collected from the participants on Day 0 and Day 56. A window period of ± 3 days will be provided for stool sample collection. Participants will be provided with a stool sample collection kit with sample collection instructions on screening day and day 28. Stool samples will be collected from participants's homes or on site at Day 0 and Day 56. The samples will be further stored for future analysis of metagenome NGS sequencing. Stool samples will be collected from the participants and shipped to the central lab in gel ice pack. Stool samples for NGS will be stored at -80 degrees until shipped to the central lab	Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo Difference in the usage of rescue medication throughout the study duration as compared to placebo	Bowel movement within 24 hours of consuming the rescue medication will not be considered as an SBM or a CSBM	through study completion, an average of Day 84

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Actual): March 14, 2026
• Study Completion (Actual): March 14, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; microcrystalline cellulose
• Other Study ID Numbers: KE/240401/BK+/FC V.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No