| CTRI Number |
CTRI/2025/06/088841 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This is a clinical Trial to Evaluate the Efficacy
and Safety of Bacillus clausii PBC429™ in the Treatment of Antibiotic-associated diarrhea in Paediatric and Adult Populations. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group clinical study to Evaluate the Efficacy
and Safety of Bacillus clausii PBC429™ in the Treatment of Antibiotic-associated diarrhea in Paediatric
and Adult Populations. |
| 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 Mitesh Raj |
| Designation |
Principal Investigator |
| Affiliation |
Matis Multispeciality Hospital |
| Address |
Matis Multispeciality Hospital
Adani CNG Gas Station Opp. Motera cross Road Near Motera Bus Stop Motera, Ahmedabad-380005
Ahmadabad
GUJARAT
380005
India |
| Phone |
9909909671 |
| Fax |
|
| Email |
Miteshraj83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mitesh Raj |
| Designation |
Principal Investigator |
| Affiliation |
Matis Multispeciality Hospital |
| Address |
Matis Multispeciality Hospital
Adani CNG Gas Station Opp. Motera cross Road Near Motera Bus Stop Motera, Ahmedabad-380005
Ahmadabad
GUJARAT
380005
India |
| Phone |
9909909671 |
| Fax |
|
| Email |
Miteshraj83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohel Shaikh |
| Designation |
Manager-Scientific Affaires |
| Affiliation |
Pellucid Lifesciences Pvt. Ltd |
| Address |
1601/1602A Yash Anant Opp Old RBI Bank Next to Atma House Ashram Road Ahmedabad-380009 Gujarat India
Ahmadabad
GUJARAT
380009
India |
| Phone |
9822979295 |
| Fax |
|
| Email |
sohel@pellucidlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Pellucid Lifesciences Pvt. Ltd.
1601/1602A Yash Anant, Opp Old RBI
Bank, Next to Atma House, Ashram Road,
Ahmedabad-380009 Gujarat India. |
|
|
Primary Sponsor
|
| Name |
Pellucid Lifesciences Pvt. Ltd. |
| Address |
Pellucid Lifesciences Pvt. Ltd.
1601/1602A Yash Anant, Opp Old RBI
Bank, Next to Atma House, Ashram Road,
Ahmedabad-380009 Gujarat India. |
| Type of Sponsor |
Other [Probiotic Manufacturing Biotechnology Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Kumar Gupta |
M.V Hospital and Research Centre |
M.V Hospital and Research Centre
314/30, Mirza Mandi, Chowk, Lucknow-226003, Uttar Pradesh; India
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Mitesh Raj |
Matis Multispeciality Hospital |
Matis Multispeciality Hospital
Adani CNG Gas Station Opp. Motera cross Road Near Motera Bus Stop Motera, Ahmedabad-380005
Ahmadabad
GUJARAT |
9909909671
Miteshraj83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Inst. Ethics Committee for MV Hospital and Research centre |
Approved |
| Shakti Hospital 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 |
| Intervention |
Bacillus clausii PBC429™ (Sachet) |
For Paediatric 2 Sachets per day (Total 4 billion CFU per day)
and for adult 3 Sachets per day (Total 6 billion CFU per day) for 7 days |
| Comparator Agent |
Placebo |
For Paediatric 2 Sachets per day and for adult 3 Sachets per day for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
To be eligible for the study, Participants must meet the following criteria:
1. Male and females aged 2 and 65 years completed years (both inclusive) with
symptoms of antibiotic treatment induced diarrhea manifesting within at least
48 hours or more, at the time of screening
2. Participants with diarrhea due to ongoing antibiotic therapy (Participants should
be on the initial 3-4 days of antibiotic therapy).
3. Participants have experienced at least three incidences of unformed stool (Type 6 & Type 7 by Bristol Stool form scale) within last 24 hours at the time of screening.(Annexure I).
4. Participants treated with physician’s prescribed broad-spectrum antibiotics for
the last 5 days (e.g., Beta lactam, lincomycin, cephalosporin and macrolide class).
5. Willing to give written informed consent or assent form by study participants or parents wherever applicable and able to follow all study procedures. |
|
| ExclusionCriteria |
| Details |
Participants with any of the following conditions will be excluded from the study:
1. Severe dehydration needing hospitalization.
2. Participants with bloody or purulent stool, with pus or mucus.
3. An axillary temperature greater than (greater than) 38.2°C or an oral temperature greater than 38.6°C
4. Symptoms of septicemia (Fever, shivering, or feeling cold, fast heart rate, fast breathing and shortness of breath, sweaty or clammy skin, etc.)
5. Unable to take medication orally or tolerate oral rehydration.
6. Taken probiotics prior to study (2 weeks) or during study other than investigational products.
7. History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers,
upper gastrointestinal bleeding, autoimmune gastritis and GERD.
8. Use of any laxative within 1 week before initiating study IP therapy.
9. Use of any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP treatments.
10. History of intubations for co-morbidities (chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.
11. Use of any investigational drug currently or within 30 days prior to study entry.
12. Participant with immuno-compromised ailments such as HIV, Hepatitis B.
13. History of any psychiatric disease (including Alzheimer’s disease, Parkinson’s disease), or any other serious medical illness.
14. Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of participants in the treatment group who achieved a Bristol
Stool Scale type 3-4 (formed to normal stools) within 48 hours of initiation of
treatment. |
Visit-1 (Day 1), Visit-2 (Day
03±1), Visit-3(Day
05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to Resolution of Diarrhea – mean time, time taken for participants to
achieve a BSS type 3-4 stool (normal to formed stool) from the start of treatment. |
Visit-1(Day 1), Visit-2(Day
03±1), Visit-3(Day
05±1), Visit-4(Day 08±1) & Visit-5(Day 14) |
Frequency of Diarrheal Episodes - The number of diarrheal episodes per day in
the first 48 hours post-treatment initiation. |
Visit-1(Day 1), Visit-2(Day
03±1), Visit-3(Day
05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14) |
Change in Abdominal Pain & other GI symptoms within 24 Hours after initiation
of treatment:
To assess the change in abdominal pain and other GI symptoms severity using the
Gastrointestinal symptoms Questionnaire (GSQ) |
Visit-1(Day 1), Visit-2(Day
03±1), Visit-3(Day
05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14) |
Tolerability of IP: To evaluate tolerability based on the frequency, severity, and
relationship of adverse events (AEs) to the study product. |
Visit-2(Day
03±1), Visit-3(Day
05±1), Visit-4 (Day 08±1) & Visit-5 (Day 14) |
Incidence of clinical and laboratory adverse events throughout the study period.
The following lab parameters would be evaluated at baseline and end of study
treatment:
• Complete Blood Count (CBC)
Hemoglobin, RBC, WBC, Platelets, Hematocrit, and MCV.
• Liver Function Tests (LFT)
Albumin, ALT, AST, Bilirubin, and Total Protein.
• Kidney Function Tests (KFT)
Blood Urea, BUN, Calcium, eGFR, Sodium, Potassium, Serum
Creatinine, and Serum Uric Acid.
• Urine Analysis (Routine analysis)
Colour, pH, Glucose, Protein, Blood & Bilirubin
• Random Blood Sugar (RBS).
|
Visit-1(Day 1) & Visit-4(Day 08±1) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
24/06/2025 |
| 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) |
Open to Recruitment |
|
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 randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate the efficacy and safety of Bacillus clausii PBC429™ in treating antibiotic-associated diarrhea (AAD) in pediatric and adult populations. AAD is a common complication of antibiotic therapy, characterized by disruptions in the intestinal microbiota. It can range from mild, self-limiting episodes to severe colitis, significantly impacting patients’ quality of life and increasing healthcare burdens. Probiotics, particularly Bacillus clausii, have gained attention for their potential in preventing and managing AAD. B. clausii benefits by restoring gut microbiota balance, enhancing mucosal immunity, and inhibiting pathogenic bacteria. The study will enroll 120 participants (60 per group), who will receive either Bacillus clausii PBC429™ (4 billion CFU/day for children, 6 billion CFU/day for adults) or a placebo for 7 days. Each participant will undergo a total treatment duration of 7 days, with an overall study participation period of 14 days. The primary objective is to assess the proportion of participants achieving normal stool consistency (Bristol Stool Scale type 3–4) within 48 hours of treatment initiation. Secondary objectives include evaluating the time to diarrhea resolution, frequency of diarrheal episodes, changes in abdominal and gastrointestinal symptoms using the Gastrointestinal Symptom Questionnaire (GSQ), and assessing tolerability and safety through adverse event monitoring and laboratory investigations. |