| CTRI Number |
CTRI/2022/07/044154 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to see effect and Safety of Bacillus subtilis HU58 plus Bacillus coagulans SC208 Capsules in subjects with irritable bowel syndrome with diarrhoea |
|
Scientific Title of Study
|
A Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilis HU58 plus Bacillus coagulans SC208 Capsules in subjects with diarrhoea predominant Irritable Bowel Syndrome (IBS-D). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-SYN-003 Version 1.0 dated 07 Jun 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Dr Sanjeev Khanna Clinic |
| Address |
E2, Ground floor, Vishal Apartments, Behind Vishal Hall, M.V.Road, Andheri East, Mumbai-400 069
Mumbai
MAHARASHTRA
400069
India |
| Phone |
9820055090 |
| Fax |
|
| Email |
dr.sanjeevkhanna@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, Second Floor, Highland Corporate
Center,Kapurbawdi Junction, Thane (W),Maharashtra
Thane
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai,
Maharashtra
Mumbai
MAHARASHTRA
400071
India |
| Phone |
02262669600 |
| Fax |
|
| Email |
SSAJ@novozymes.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences, Pvt. Ltd.-A Novozymes One Health Company , Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd A Novozymes One Health Company |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeev Khanna |
Dr Sanjeev Khanna Clinic |
E2, Vishal Apartments, Behind Vishal Hall, M.V.Road, Andheri East, Mumbai-400 069
Mumbai
MAHARASHTRA |
9820055090
dr.sanjeevkhanna@yahoo.com |
| Dr Ashwin Porwal |
Healing Hands Clinic |
4th Ploor, Millenium star extension,adjacent to Ruby Hall,
Dhole Patil Road, Pune -411001
Pune
MAHARASHTRA |
9822347770
drashwinporwal@gmail.com |
| Dr Dharmendra BL |
Mysore Medical College & Research Institute and Associated Hospitals, K.R. Hospital |
Department of Surgical Gastro Enterology, K.R.Hoapital, Irwin Road, Mysore-570001, Karnataka
Mysore
KARNATAKA |
9844400382
drdharmu21@gmail.com |
| Dr Pravin Nagulal Soni |
PCMCs PGI Yashwantrao Chavan Memorial Hospital |
Room no 03 2nd floor
Department of Medicine
YCM Hospital Rd, Sant
Tukaram Nagar, Pimpri
Colony, Pune,
Maharashtra 411018
Pune
Pune
MAHARASHTRA |
9822057511
drpravinsoni18@gmail.com |
| Dr Deepak Siddavaram |
Saideep Healthcare & Research Centre |
Clinical Research Department, 7th Floor,Viraj Estate,Behind Yashwant Colony,Near DSP Chowk,Ahmednagar-414003,Maharashtra,India
Ahmadnagar
MAHARASHTRA |
9822037288
sdrdeepak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Healing Hands Institutional Ethics Committee |
Approved |
| IEC-MMC and RI and Associated Hospital Mysuru |
Approved |
| Institutional Ethics Committee Yashwantrao Chavan Memorial Hospital, Pimpri |
Approved |
| Institutional Ethics Committee, Saideep Hospital Ahmednagar |
Approved |
| Vcare Independent Ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus subtilis HU58 Plus Bacillus coagulans SC208 Capsules |
One capsule twice daily for 28 days |
| Comparator Agent |
Placebo Capsules |
One capsule twice daily for 28 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female subjects between 18 to 65 years of age both inclusive.
2. Subjects diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
i. Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria:
- Related to defecation
- Associated with a change in stool frequency (increase/decrease in frequency).
- Associated with a change in the form (appearance) of stool.
ii. History of abnormal bowel movements predominantly diarrhoea (>25% of bowel movement categorized as stool form type 6 or 7 (diarrhoea) and <25% as stool form type 1 or 2 constipation) on Bristol stool form scale (BSFS).
3. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
4. At end of screening period
- Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of ≥ 3.0 on a 0 to 10-point scale and
- At least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week). |
|
| ExclusionCriteria |
| Details |
1. Subjects with Constipation-predominant irritable bowel syndrome (IBS), or diarrhoea other than that associated with IBS.
2. Subjects with known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
3. Subjects with a history of coeliac disease, Inflammatory Bowel disease, bowel cancer, bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
4. Subjects with history of unexplained weight loss or rectal bleeding.
5. Subjects with acute GI tract infection
6. Subjects requiring antibiotics for the treatment of Diarrhoea
7. Subjects with Type 1 Diabetes or Uncontrolled Type 2 Diabetes Mellitus.
8. Subjects with clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, and other gastrointestinal diseases.
9. Use of antidepressant agents, unless used at a stable dose for at least 2weeks prior to screening.
10. Subjects with current evidence of clinically significant severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, hematopoietic, Neurologic, psychiatric, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of the Investigational product.
11. Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
12. Subjects with a history of food allergies and lactose intolerance.
13. Subject with history of alcohol or drug abuse in the past 3 months prior to screening visit.
14. Subjects with a history of intake of Any Probiotic, Prebiotic, symbiotic containing formulations, antibiotics (Rifaximin, metronidazole, or any other), Bile acid sequestrants(Cholestyramine ,Colesevelam and Colestipol), 5-hydroxytryptamine (serotonin) 3 receptor antagonists (such as Alosetron) and Eluxadoline within two weeks prior to the screening day.
15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
16. Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
17. Suspected inability or unwillingness to comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects defined as responders for abdominal pain and stool consistency from baseline to end of study. |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects who were responders for abdominal pain from baseline to the end of study. |
28 Days |
| Percentage of subjects who were responders for Stool Consistency Scores from baseline to the end of study. |
28 Days |
| Change in Stool Consistency (Bristol stool score (BSS) from baseline to the end of study |
28 Days |
| Change in Abdominal Pain Intensity (0 to 10 point NRS scale) from baseline to the end of study. |
28 Days |
| Change in Perceived Stress Scale (PSS) from baseline to the end of study. |
28 Days |
| Percentage of IBS Global Assessment of Improvement Scale (IBS-GAI) responders from baseline to the end of study. |
28 Days |
| Change in stool sample measurement for Short-chain fatty acids SCFAs levels from baseline to the end of study |
28 Days |
| Changes in diversity of gut microbiota observed through DNA extraction and 16S rRNA gene sequencing from baseline to the end of study |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilisHU58 + Bacillus coagulans SC208 Capsules in subjects with diarrhoea predominant Irritable Bowel Syndrome(IBS-D).
The randomization visit will be conducted on Day 1 after 7 days of the screening period (Visit 1) wherein the subject will be randomized after assessing the diary scores for eligibility.
Eligible subjects will be randomized in two arms in ratio 1:1.The follow up visits will be conducted on Visit 2 (Day 8±1) Visit 3 (Day 15±1) Visit 4 (Day 22±1) and end of study visit will be conducted at Visit 5 (Day 29±1). A Post Treatment Safety Follow up visit will be conducted at Visit 6 (Day 36±2). The duration of individual participation will be approximately 43 days.
The primary outcome evaluates Percentage of participants defined as responders for abdominal pain and stool consistency from baseline to end of study.
The secondary outcome evaluates Percentage of subjects who were responders for abdominal pain, Percentage of subjects who were responders for Stool Consistency Scores, Change in Stool Change in Perceived Stress Scale (PSS),Percentage of IBS Global Assessment of Improvement Scale (IBS-GAI) responders, Change in stool sample measurement Short-chain fatty acids SCFAs levels and Changes in diversity of gut microbiota observed through DNA extraction and 16S rRNA gene sequencing from baseline to the end of study. |