Clinical trial NCT06730594: A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Constipation
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment A randomized, double-blind, two-arm, placebo-controlled clinical study
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs)
timeFrame: per week from baseline to the end of study visit.
Secondary outcomes:
measure: 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)
timeFrame: Baseline to Day 84
measure: 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)
timeFrame: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
measure: 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)
timeFrame: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
measure: 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 SBM with no sensation of incomplete evacuation
timeFrame: Baseline to Day 84
measure: To assess the effect of Investigational product (IP) in comparison to baseline and placebo Gut microbiome (alpha and beta diversity)
timeFrame: Baseline to Day 84
measure: 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.
timeFrame: through study completion, an average of Day 84
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Anand Multispeciality Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: HCG Hospitals
state: Gujrata
city: Kalyān
country: India
facility: Jan Kalyan Multispeciality Hospital
state: Maharashtra
city: Nashik
country: India
facility: Signus Hospital
state: Maharashtra
city: Pune
country: India
facility: AK Superspeciality Clinic
state: Maharashtra
city: Pune
country: India
facility: Lifeline multispecialty Hospital
state: Maharashtra
city: Pune
country: India
facility: Care Multispecialty Hospital
state: Maharashtra
city: Varanasi
country: India
facility: Krishna Hospital
state: Uttar Pradesh
Study officials:
References: