FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/07/026863 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 14/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of probiotic vs placebo in Non Constipated Irritable Bowel Syndrome 
Scientific Title of Study   Multicentric, Phase IV, randomized, double blind, placebo controlled trial to assess effectiveness and safety of Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12® in the treatment of Non-Constipated Irritable Bowel Syndrome in adults aged 18 years to 65 years. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MC/PVD/PRB/19-002  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashok Jaiswal 
Designation  Medical Advisor, Medical and Regulatory Affairs 
Affiliation  ZYDUS HEALTHCARE LIMITED 
Address  Zydus Healthcare Limited, CTS No. 460/6, I. B. Patel Road, Village Pahadi, Goregaon (East), Mumbai 400063, Maharashtra,

Mumbai
MAHARASHTRA
400063
India 
Phone  7600014339  
Fax    
Email  AshokD.Jaiswal@zyduscadila.com  
 
Details of Contact Person
Scientific Query  
Name  Ashok Jaiswal 
Designation  Medical Advisor, Medical and Regulatory Affairs 
Affiliation  ZYDUS HEALTHCARE LIMITED 
Address  Zydus Healthcare Limited, CTS No. 460/6, I. B. Patel Road, Village Pahadi, Goregaon (East), Mumbai 400063, Maharashtra,

Mumbai
MAHARASHTRA
400063
India 
Phone  7600014339  
Fax    
Email  AshokD.Jaiswal@zyduscadila.com  
 
Details of Contact Person
Public Query  
Name  Ashok Jaiswal 
Designation  Medical Advisor, Medical and Regulatory Affairs 
Affiliation  ZYDUS HEALTHCARE LIMITED 
Address  Zydus Healthcare Limited, CTS No. 460/6, I. B. Patel Road, Village Pahadi, Goregaon (East), Mumbai 400063, Maharashtra,

Mumbai
MAHARASHTRA
400063
India 
Phone  7600014339  
Fax    
Email  AshokD.Jaiswal@zyduscadila.com  
 
Source of Monetary or Material Support  
Zydus Healthcare Limited 
 
Primary Sponsor  
Name  Zydus Healthcare Limited 
Address  ZYDUS HEALTHCARE LIMITED, Zydus Healthcare Limited, CTS No. 460/6, I. B. Patel Road, Village Pahadi, Goregaon (East), Mumbai 400063, Maharashtra, 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manas Kumar Panigrahi  All India Institute of Medical Sciences, Bhubaneswar  All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha 751019
Cuttack
ORISSA 		 9438884267

medgast_manas@aiimsbhubaneswar.edu.in 
Dr Pravin Motilal Rathi  B.Y.L. Nair Ch. Hospital & T.N. Medical College, Mumbai Central, Mumbai  Topiwala National Medical College and BYL Nair Ch. Hospital, G Building, Ground Floor, Dr. A.l. Nair Road, Mumbai - 400008
Mumbai
MAHARASHTRA 		 9322406438

rathipm@live.in 
Dr Akash Shukla  KEM Hospital  Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 9869256376

drakashshukla@yahoo.com 
Dr Indraneel Saha  Peerless Diagnostic Centre  Peerless Diagnostic Centre, 223 Chittaranjan Avenue, Kolkata, West Bengal 700006
Kolkata
WEST BENGAL 		 9831000396

isjsid@yahoo.co.in 
Dr Uday Ghoshal  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Sanjay Gandhi Postgraduate Institute of Medical Sciences Raebareli Road Lucknow – 226014
Lucknow
UTTAR PRADESH 		 9628842456

udayghoshal@gmail.com 
Dr BS Ramakrishna  SRM Institute of Medical Sciences  No.1, Jawaharlal Nehru Salai, Vadapalani, Chennai
Chennai
TAMIL NADU 		 9994614890

wurama@hotmail.com 
Dr Karmabir Chakravartty  Woodlands Hospital  8/5, Alipore Road, Kolkata – 700 027
Kolkata
WEST BENGAL 		 9830058059

karmabir.c@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Hurip Independent Bioethics Committee  Approved 
Hurip Independent Bioethics Committee  Approved 
Institutional Ethics Committee SRM Institute of Medical Sciences  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
Institutional Ethics Committee, Sanjay Gandhi Institute of Post Graduate Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital  Approved 
Institutional Ethics Committee, Topiwala National Medical College and BYL Nair Ch. Hospital  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, (2) ICD-10 Condition: K582||Mixed irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Identical Placebo administered orally twice daily for 12 weeks given concomitantly with standard of care treatment 
Intervention  Providac  Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12®in dosage of total 1 billion CFU per capsule, administered orally twice daily for 12 weeks given concomitantly with standard of care treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects in the age group of 18-65 years (both ages inclusive) with a positive diagnoses of non-constipated IBS ) diagnosed based on responses to the Enhanced Asian ROME 3 Questionnaire
2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before study.
3. Able to provide signed informed consent and be able to comply with study procedures 
 
ExclusionCriteria 
Details  1.Subjects with Constipation Predominant IBS (IBS-C)
2.Subjects with history of major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease, structural abnormalities of the gastrointestinal tract other than oesophagitis or gastritis allergic diseases.
3.Other organic or major psychiatric disorders such as schizophrenia manic depressive conditions as assessed by medical history, appropriate consultations and laboratory tests. 4.Faecal occult blood test positive
5.Pregnant or Lactating mothers
6.Any other medical condition in the opinion of the investigator rendering the subject ineligible to participate.
7.Use of antibiotics or probiotics in the three weeks preceding study start. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients.  • Number and proportion of responders in each arm who experience improvement in symptoms recorded by IBS Global Improvement Scale (IBS-GIS):
• A responder defined as a patient who answered that their symptoms were either “moderately improved” or “substantially improved”. The weekly numerical evaluation of abdominal pain from baseline to treatment end of 12 weeks as defined in the daily symptom diary
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effects of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on health-related quality of life using the questionnaires IBS-QoL EAR3Q and IBS-SSS.  Numerical evaluation of changes in scales from baseline to treatment end of 12 weeks.
The number of pain free days from baseline to treatment end of 12 weeks
ï‚· The weekly numerical evaluation of abdominal discomfort, straining and bloating from baseline to treatment end of 12 weeks
ï‚· The difference in scores of urgency of defecation from baseline to end of 12 weeks
ï‚· Percentage reduction of 50% and above in abdominal pain scores from baseline to end of 12 weeks. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/08/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   The findings of this study may be published in a scientific journal or presented at a scientific meeting with prior permission from the sponsor and the Investigator. The sponsor and the Investigator reserves the right to review all manuscripts prior to submission for publication or any paper before it is presented. In accordance with standard editorial and ethical practice, the sponsor will generally support publication of multicentric trials only in their entirety and not as individual center data. Authorship will be determined by mutual agreement between the sponsor in conjunction with the CRO and the Principal investigator(s).  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study proposes to add to the existing literature from clinical trials that have established that changes in intestinal microflora with different therapeutic approaches, such as the use of prebiotics, probiotics, synbiotics, and nonabsorbable and systemic antibiotics prove effective in symptom alleviation in IBS. The objectives of the study are to determine the effectiveness of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on the abnormal defecation and abdominal pain and discomfort in non-constipated IBS patients. Secondary objective is to determine the effects of 12 weeks consumption of Lactobacillus acidophilus, LA-5® and Bifidobacterium animalis ssp. lactis, BB-12® on health-related quality of life using the questionnaires IBS-QoL EAR3Q and IBS-SSS. 
Close