| CTRI Number |
CTRI/2025/10/096367 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study in adults with newly developed diarrhea is testing Bacillus clausii probiotic against another treatment to see if it helps people recover faster and is safe to use. |
|
Scientific Title of Study
|
A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical
Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation
in Adult Patients with Acute diarrhea. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishesh Jain |
| Designation |
Sr. Consultant - Internal Medicine (Diabetology) |
| Affiliation |
Chandra Laxmi Hospital |
| Address |
Chandra Laxmi Hospital, Plot No. 336, 337, 338, and 340 Kali Mandir, Yasodha Marg,
Sector 4, Vaishali, Ghaziabad, Uttar Pradesh
Chandra Laxmi Hospital, Plot No. 336, 337, 338, and 340 Kali Mandir, Yasodha Marg,
Sector 4, Vaishali, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201019
India |
| Phone |
09899785678 |
| Fax |
|
| Email |
dr.nisheshjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka,
New Delhi, Delhi, 110075
West
DELHI
110075
India
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka,
New Delhi, Delhi, 110075
West
DELHI
110075
India
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka,
New Delhi, Delhi, 110075
West
DELHI
110075
India
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka,
New Delhi, Delhi, 110075
West
DELHI
110075
India
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Advenza Global limited
Unit No. 424, 4th Floor, Lodha Supremus II, Rd Number 22, Wagle Industrial Estate, Thane, Maharashtra 400604 |
|
|
Primary Sponsor
|
| Name |
Advenza Global limited |
| Address |
Unit No. 424, 4th Floor, Lodha Supremus II, Rd Number 22, Wagle Industrial Estate, Thane, Maharashtra 400604. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nishesh Jain |
Chandra Laxmi Hospital |
Plot No. 336, 337, 338, and 340 Kali Mandir, Yasodha Marg, Sector 4, Vaishali, Ghaziabad, Uttar Pradesh 201019
Ghaziabad
UTTAR PRADESH |
9899785678
dr.nisheshjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee GeneBandhu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii spores suspension (Strain AVZ 7911) |
Arm 1: Bacillus Clausii Containing 2x10^6 cfu for oral administration two times a day along with ORS for a period of 10 days. |
| Comparator Agent |
Market product (Enterogermina) |
Market product for oral administration two times a day along with ORS for a period of 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant with clinical diagnosis of acute diarrhea - experienced greater than or equal to 3 loose stools within 24 hours for less than 7 days.
2. Male or female adults aged between 18 to 60 years (both inclusive).
3. Patients who have not received antibiotic or probiotic treatment in the last
7 days.
4. Willingness to comply with study protocol/ written informed consent and attend all scheduled visit |
|
| ExclusionCriteria |
| Details |
1. Patients with chronic or persistent diarrhea more than 7 days.
2. History of inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorders.
3. Patients with severe dehydration requiring intravenous rehydration.
4. Use of antibiotics, antifungals, or other probiotics within the past 7 days.
5. Patient with current use of any other probiotic supplements, antidepressants, antipsychotic or appetite suppressant medicines, or tryptophan (to aid sleep), weight altering medications including homeopathic, ayurvedic, herbal (especially St. John’s wort), Tibetan or Unani preparations, or systemic steroids (chronic use, more than 2 weeks).
6. Patients with bloody or purulent stool, with pus or mucus and severe dehydration needing hospitalization. Subjects with symptoms of septicaemia, faster heart rate and breathing, shortness of breath, sweaty or clammy skin.
7. Participants who have used kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents within 48 hours prior to participation in this study.
8. Pregnant or lactating women.
9. Patients with a history of immunosuppressive conditions or therapy.
10. Known hypersensitivity or allergy to Bacillus clausii.
11. Refer protocol for all. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the frequency of defecation (number of stools per day).
Change in the total duration of diarrhoea (in minutes)
Change in Stool consistency evaluated on the basis of Bristol stool form scale.
Change in Abdominal pain score evaluated on a scoring system on the basis of 5-point Likert-Type Symptom Severity Scale
The use of rescue medication. |
baseline day 3, day 6, day 8 and day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in stool examination (stool fat, stool mucus, occult blood, RBC, WBC, ova and parasites in stool).
2.Proportion of participants meeting the recovery criteria, where recovery is
defined as either the passage of two consecutive normal stools based on the
BSFS or the absence of stool production (zero) recorded. |
1.baseline and day 10.
2.in the 12-hour period, immediately preceding each scheduled visit assessed on Days 3, 6, 8, and 10. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
06/11/2025 |
| 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="0"
Months="6"
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
|
A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical
Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation
in Adult Patients with Acute diarrhea. This study is a Prospective, Parallel arm, Randomized, Double-Blind, comparative
clinical trial to assess efficacy, safety and tolerability of Bacillus clausii spores
suspension (Strain - AVZ 7911) and Market product in the treatment of participants
suffering from acute diarrhoea.Assuming 10% dropout rate, 42 study subjects (21 participants in each arm) will be
enrolled in the study and randomized in 1:1 ratio.
|