| CTRI Number |
CTRI/2025/01/079362 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults with Functional Constipation |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| KE/240401/BK/FC Version No: 2 Date: 14th August, 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Rushikesh Londhe |
| Designation |
Clinical Project Lead-Opertion |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban)
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655737996 |
| Fax |
|
| Email |
rushikesh.l@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai
–400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Katare |
AK Superspeciality Clinic, |
AK Superspeciality Clinic, Unit 208, 2nd Floor, Commercial Building (Kul Scapes), Tukaram Nagar, Near Reliance Mart, Kharadi Pune, Maharashtra, India
Pune
MAHARASHTRA |
8830793201
drkatareps@gmail.com |
| DrAnand Patel |
Anand Multispeciality Hospital |
Anand Multispeciality Hospital, B Tower, sundervan complex, Gorwa Refinery Rd,
near Gorwa, beside IOCL Petrol pump, Gorwa, Vadodara, Gujarat 390016
Vadodara
GUJARAT |
9825576663
amhbaroda@gmail.com |
| Dr Dilip Kadam |
Care Multispecialty Hospital |
Care Multispecialty Hospital, Kolte Arcade, Pune- Nagar Road,Wagholi Pune-412207, Maharashtra, India.
Pune
MAHARASHTRA |
7066115411
drdilipnkadam@gmail.com |
| Dr Mahesh Mahadik |
GASTRO HUB Hospital |
GASTRO HUB Hospital, Royal Radiance, Wakad- Bhosari BRTS Rd, Survey No. 18,
Next to spot 18, Rahatani, Pimpri-Chinchwad, Pune, Maharashtra 411027
Pune
MAHARASHTRA |
9890819432
maheshkood@gmail.com |
| Dr Rohit Singh |
Krishna Hospital, |
Krishna Hospital,Amara Chitalpur Road, Akhri Bypass, Varanasi-221005, Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
7991956262
iambigr@yahoo.co.in |
| Dr Suhas Dhole |
Lifeline multispecialty Hospital |
Lifeline multispecialty Hospital Nano Homes, Bhondve Chowk Ravet Pune, Maharashtra, India.
Pune
MAHARASHTRA |
9822590576
Dhole.vmgmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Altezza Instutional Ethics Committee |
Approved |
| Anand Institutional Ethics Committee |
Approved |
| Care Multispeciality Hospital Institutional Ethics Committee |
Approved |
| Central Independent Ethics Committee |
Approved |
| Central Independent Ethics Committee-CIEC |
Approved |
| Krishna Ethics Committee K Krishna Hospital |
Approved |
| Signus Hospital Ethics Committee |
Approved |
| Supreme Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One capsule to be taken orally once day before breakfast For 84 days |
| Intervention |
VL-BK-02 |
One capsule to be taken orally once day before breakfast For 84 Days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants agreed to the signed and dated informed consent form.
2.Male and female individuals of age between 18 to 60 years.
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:
a)Fewer than three SBMs per week
b) Straining during more than ¼ (25%) of defecations
c) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
d) Sensation of incomplete evacuation more than ¼ (25%) of defecations
e) Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
f) 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.
|
|
| ExclusionCriteria |
| Details |
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.
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.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per week |
from baseline to the end of study visit. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess the effect of Investigational product (IP) in comparison to baseline & placebo on stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit. |
from baseline to the end of study visit |
| To assess the effect of Investigational product (IP) in comparison Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM) |
from baseline to day 14, day 28, day 42, day 56, day 70 & day 84. |
| To assess the effect of Investigational product (IP) in comparison Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL) |
from baseline to day 14, day 28, day 42, day 56, day 70 & day 84. |
| To assess the effect of Investigational product (IP) in comparison to Percentage responders defined as the number of participants with an increase by 1 or more frequencies of SBM with no sensation of incomplete evacuation |
from baseline to the end of intervention |
| To assess the effect of Investigational product (IP) in comparison Gut microbiome (alpha & beta diversity) |
from baseline to end of intervention |
| To assess the effect of Investigational product (IP) in comparison Difference in the usage of rescue medication |
throughout the study duration as compared to placebo |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |