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CTRI Number  CTRI/2024/10/076025 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Utility of Bismuth Subcitrate in Irritable Bowel Syndrome 
Scientific Title of Study   Role of Bismuth Citrate in Irritable Bowel Syndrome Diarrhoea 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Dahale 
Designation  Associate professor 
Affiliation  Dr D.Y. Patil Medical Hospital and Research Institute 
Address  Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri , Pune
Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  09873096779  
Fax    
Email  amolsd1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajay Pranami 
Designation  Senior Resident 
Affiliation  Dr D.Y. Patil Medical Hospital and Research Institute 
Address  Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9993789141  
Fax    
Email  ajaymbbs2006@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrAmol Dahale 
Designation  Associate professor 
Affiliation  Dr D.Y. Patil Medical Hospital and Research Institute 
Address  Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9873096779  
Fax    
Email  amolsd1986@gmail.com  
 
Source of Monetary or Material Support  
Dr D.Y.Patil Medical College Hospital and Research Centre. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amol Dahale  Dr D.Y.Patil Medical College Hospital and Research Centre, Dr D.Y.Patil Vidyapeeth  Department of Medical Gastroenterology , 1st Floor Old Medical college building, Dr D.Y.Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri 411018
Pune
MAHARASHTRA 		 9873096779

amolsd1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS SUB-COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mebeverine  Tab. Mebeverine 135 mg twice a day for 14 days will be given as a standard care to all the patients. 
Intervention  Rifaximin and Bismuth subcitrate  Tab. Rifaximin 550 mg twice a day for 14 days and Tab. Bismuth Subcitrate 120 mg twice a day for 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1) Patients with IBS-D aged 18–49 years,
2) Diagnosed according to the Rome IV criteria.
 
 
ExclusionCriteria 
Details  1) Old aged patients ( more than 50yrs)
2) Pregnant women
3) Documented chronic heart or liver failure
4) Surgery on the gastrointestinal tract except appendectomy
5) Malabsorption diseases
6) Hyperthyroidism, Diabetes mellitus
7) Inflammatory bowel diseases
8) Connective tissue diseases
9) Use of antibiotic drugs within 1 month before the study
10) Significant weight loss, fever, and bloody stools
11) Lost to follow up
12) Drugs affecting gut motility
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate improvement in abdominal pain using 11 points NRS scale.
2) To evaluate improvement in BSFS.

 		 1) visit 3 -2nd week( site visit)
2) Visit 5- 4th week ( site visit)
3) Visit 7 - 3rd month( site visit) 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the responder rates for abdominal pain & stool abnormalities separately.
2) To evaluate stool frequency (CSBM & SBM) & stool consistency in both arms.
3) To evaluate abdominal pain & the evaluation of the number of pain free days.
4) To evaluate the numerical & responder on abdominal discomfort & bloating.
5) To evaluate urgency of defecation, distension.
6) To evaluate the Quality of Life using validated generic & disease specific Quality of Life scales.
 		 1) Visit 2- 1st week telephonic visit
2) Visit 3- 2nd week site visit
3) Visit 4-3rd week telephonic visit
4) Visit 5- 4th week site visit
5) Visit 6- 2nd month telephonic visit
6) Visit 7-3rd month site visit.
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

This will be a prospective interventional , open labelled, randomized, parallel group active controlled trial. This study aim to evaluate the efficacy of Bismuth subcitrate with Rifaximin. In this study 68 adults will be enrolled . Participants will be screened and eligible participants will be enrolled in the study. Study duration of this study will be 8 months.

 

After randomization , all patients shall be given standard medical treatment (Tablet Mebeverine – 135 mg twice a day for 14 days) for IBS diarrhoea. In addition to that, patients will be randomised into two groups. Patients in the 1st group will receive standard care along with Tablet Rifaximin 550 mg twice a day (Group A) and patients in the 2nd group will receive standard care with Tablet Bismuth subcitrate 120 mg twice a day for 14 days(Group B) .

 

Follow up visits of patients will be seven  (four phisical visits and three telephonically visits).

 

 

Primary Objective:

1)     1)  To evaluate improvement in abdominal pain using 11 points NRS scale.

2)     2)  To evaluate improvement in BSFS.

Secondary Objective:

1)     1) To evaluate the responder rates for abdominal pain and stool abnormalities separately.

2)      2)To evaluate stool frequency (CSBM and SBM) and stool consistency in both arms. 

3)      3)To evaluate abdominal pain and the evaluation of the number of pain free days.

4)      4) To evaluate the numerical and responder on abdominal discomfort and bloating.

5)      5) To evaluate urgency of defecation, distension.

Data on the quality of life and IBS symptoms (severity of abdominal pain, severity of bloating and abdominal discomfort, and improvement of stool form) will be recorded by completing the IBS questionnaire by the patients.

 
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