| CTRI Number |
CTRI/2026/03/106968 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Assess the Safety and Effectiveness of a Probiotic Nutraceutical Product in Subjects with Diarrhea and Related Symptoms |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Assess the Safety and Effectiveness of a Probiotic Nutraceutical Product in Subjects with Diarrhea and Related Symptoms |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-ELS-177, Version 1.0 dated 02 December 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank S Gowda |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
OPD No.3, Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9591524779 |
| Fax |
|
| Email |
Drshashank@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ELMED Life Sciences Pvt. Ltd. Plot No.36, IDA, Phase V, Cherlapalli, Hyderabad, Secunderabad, Telangana-500051, India |
|
|
Primary Sponsor
|
| Name |
ELMED Life Sciences Pvt. Ltd. |
| Address |
Plot No.36, IDA, Phase V, Cherlapalli, Hyderabad, Secunderabad, Telangana-500051, India |
| Type of Sponsor |
Other [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashank S Gowda |
BGS Global Institute of Medical Sciences |
OPD No.3, Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9591524779
drshashank.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii Spores Suspension |
Orally, once a day, 30 minutes before meal for 7 days |
| Comparator Agent |
Placebo: RO water in 5 mL |
Orally, once a day, 30 minutes before meal for 7 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with acute diarrhoea having more than 3 loose stools in last 24 hours 2. Subjects with diarrhoea less than 7 days 3. Subjects who agrees to participate in this trial and signs a written consent form before the test begins. |
|
| ExclusionCriteria |
| Details |
1. Subjects with mucous stools or bleeding per rectum 2. Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors, etc 3. Subjects with a history of gastrointestinal surgery 4. Subjects with a history of malignant tumor of the digestive system 5. Subjects who have within 2 weeks of Visit 1, have taken probiotics, anti-diarrhoeal medication, H2 receptor blockers, anticholinergics, gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosa protectors, other drugs for the treatment of gastritis, and health functional foods related to gastrointestinal health 6. Subjects who must continuously take drugs that can cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin, during the human application test period however, low dose aspirin 100 mg per day or less is allowed for the purpose of preventing cardiovascular disease 7. Subjects with uncontrolled high blood pressure 8. Subjects who are sensitive or allergic to the food ingredients for this human application test 9. Subjects refusing to stop eating foods and functional foods that may affect digestive system symptoms 10. Subjects who are pregnant, lactating, or planning to become pregnant within 3 months. 11. Subjects who have participated in other interventional clinical trials within 3 months of visit 1, or who plan to participate in other interventional clinical trials after the start of this human trial. 12. Subjects judged by the tester to be inappropriate for this human application test |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the frequency of diarrhoeal episodes, duration of diarrhoeal episodes, consistency of stools assessed with Bristol stool form scale in symptomatic subjects in IP arm compared to placebo. |
Day 1, Day 3, Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in bbiomarkers |
Day 1, Day 3, Day 7 |
| Mean change in the Quality of Life in IP arm compared to placebo. |
Day 1, Day 3, Day 7 |
| Impact of the IP on gut microbiome in sub-group of subjects |
Day 1, Day 3, Day 7 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a randomized, double-blind, placebo-controlled, parallel group clinical interventional study. The subjects will be explained about the study procedures, the risks and discomforts, the investigational product (IP). Informed consent will be obtained from subjects who are willing to participate in the study. The subjects who fulfil the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. The subjects will be randomized into one of the treatment arms (1:1) as per randomization schedule. The subject will be instructed to consume the IP or placebo, orally, once a day, 30 minutes before meal for 1 week. The subjects will be required to come for the follow-up assessments on Day 3, and Day 7. Statistical comparisons for efficacy shall be made between test product and placebo. The total study duration for the clinical part shall be a maximum of 7+1 days of treatment period. |