Assessing the effects of Bio-K+ Probiotic Capsules 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

This study is testing if Bio-K+ Probiotic Capsules can help adults with functional constipation have more regular bowel movements and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Vedic Lifesciences Pvt. Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Vadodara, Gujarat and 7 other locations)
• Trial ID: NCT06730594 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Bio-K+ Probiotic Capsules (VL-BK-02) in treating functional constipation in adults aged 18 to 60. It is a randomized, placebo-controlled, double-blind study involving approximately 205 participants, with a target of 164 individuals completing the trial. Participants will be assigned to receive either the active probiotic or a placebo for 56 days, followed by a follow-up period of up to 84 days to assess safety and efficacy. The study aims to determine if the probiotic can improve bowel movement frequency and alleviate symptoms associated with functional constipation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 who meet the Rome IV criteria for functional constipation.

Not a fit: Patients who do not meet the diagnostic criteria for functional constipation or have other gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing functional constipation in adults.

How similar studies have performed: While there have been studies on probiotics for gastrointestinal issues, this specific approach with Bio-K+ Probiotic Capsules is relatively novel.

Eligibility criteria

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 is indicated by the following criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis:

   i. Fewer than three SBM per week ii. Any one or more of the below criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis:
   1. Straining during more than ¼ (25%) of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
   3. Sensation of incomplete evacuation more than ¼ (25%) of defecations
   4. Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
   5. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) iii. Loose stools are rarely present without the use of laxatives iv. 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.

Exclusion Criteria:

1. Individuals with well-known, organic causes of constipation (Polyps, hemorrhoids, etc.)
2. Individuals with anorectal pathology
3. Individuals with a history of previous gastrointestinal surgery.
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, food allergy, Frequent diarrhea without laxatives).
6. Current pharmacological treatment related to constipation (e.g. prosecretory agents, antibiotics, 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 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 before the screening.
12. Immuno-compromised participants or those on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
13. History of cancer.
14. Individuals with known history of diabetes mellitus and are on medication for the same.
15. History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
16. 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.
17. Mental or behavioral disorders as judged by the Investigator.
18. Individuals with known food allergy.
19. Individuals with eating disorders (e.g., anorexia, bulimia).
20. Pregnancy or lactation.
21. Known allergic reactions to any components of the probiotics or placebo.
22. Individuals participating in other interventional study within 90 Days prior to screening.
23. Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment.
24. Current Smokers will be excluded

Where this trial is running

Vadodara, Gujarat and 7 other locations

• Anand Multispeciality Hospital — Vadodara, Gujarat, India (Recruiting)
• HCG Hospitals — Ahmedabad, Gujrata, India (Not_yet_recruiting)
• Jan Kalyan Multispeciality Hospital — Kalyān, Maharashtra, India (Active_not_recruiting)
• Signus Hospital — Nashik, Maharashtra, India (Recruiting)
• AK Superspeciality Clinic — Pune, Maharashtra, India (Recruiting)
• Lifeline multispecialty Hospital — Pune, Maharashtra, India (Recruiting)
• Care Multispecialty Hospital — Pune, Maharashtra, India (Recruiting)
• Krishna Hospital — Varanasi, Uttar Pradesh, India (Recruiting)

Study contacts

• Study coordinator: Dr. Sanjay Vaze, MBBS

Conditions Functional Constipation