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

Launched by VEDIC LIFESCIENCES PVT. LTD. · Dec 8, 2024

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ClinConnect Summary

This clinical trial is studying the effects of Bio-K+ Probiotic Capsules on adults who experience functional constipation, a condition where individuals have difficulty passing stools. The trial aims to compare the probiotic capsules to a placebo (a pill that looks the same but has no active ingredients) to see if they can help improve bowel movements. The researchers will be looking for about 205 participants aged 18 to 60 who have been diagnosed with functional constipation based on specific symptoms.

To be eligible, participants need to agree to the study terms and meet certain criteria, like having fewer than three bowel movements per week and experiencing other related symptoms for the past three months. Those with certain medical conditions, recent surgeries, or who are currently taking specific medications that affect digestion won’t be able to participate. If someone joins the study, they can expect to take either the probiotic or placebo for 56 days and will have follow-up assessments to monitor their progress. This trial is currently recruiting participants, and it’s a great opportunity for those looking for potential relief from their constipation symptoms.

Gender

ALL

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