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CTRI Number  CTRI/2025/12/098459 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study    
Study Design  Other 
Public Title of Study   Probiotics as an Add-on Therapy for H. pylori Stomach Infection 
Scientific Title of Study   Efficacy Assessment of Probiotic Supplementation as an Adjunct to Standard Antibiotic Therapy in Patients with Helicobacter pylori Infection 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidhi Shah 
Designation  Ph.D Scholar 
Affiliation  Gujarat University 
Address  Department of Life Sciences, Food Science and Nutrition, School of Sciences, Gujarat University, Navrangupura, Ahmedabad

Ahmadabad
GUJARAT
380009
India 
Phone  7600668601  
Fax    
Email  vidhishah@gujaratuniversity.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Vidhi Shah 
Designation  Ph.D Scholar 
Affiliation  Gujarat University 
Address  Department of Life Sciences, Food Science and Nutrition, School of Sciences, Gujarat University, Navrangupura, Ahmedabad

Ahmadabad
GUJARAT
380009
India 
Phone  7600668601  
Fax    
Email  vidhishah@gujaratuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Vidhi Shah 
Designation  Ph.D Scholar 
Affiliation  Gujarat University 
Address  Department of Life Sciences, Food Science and Nutrition, School of Sciences, Gujarat University, Navrangupura, Ahmedabad

Ahmadabad
GUJARAT
380009
India 
Phone  7600668601  
Fax    
Email  vidhishah@gujaratuniversity.ac.in  
 
Source of Monetary or Material Support  
Department of Life Sciences, Food Science and Nutrition, Gujarat University,Ahmedabad, Gujarat, India -380009 
 
Primary Sponsor  
Name  Department of Life Sciences, Food Science and Nutrition, Gujarat University 
Address  School of Sciences, Gujarat University, Navrangpura, Ahmedabad, Gujarat-380009 
Type of Sponsor  Research institution 
 
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 Mikita A Suvarna  Dr. Jivraj Mehta Smarak Health Foundation  Bakeri Medical Research Centre, Paldi, Ahmedabad – 380007
Ahmadabad
GUJARAT 		 7738330540

msuvarna7393@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JMSHF,Institutional Ethics Committee-BHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K29||Gastritis and duodenitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants must be between 18 and 65 years of age, inclusive.
2. Diagnosis of Helicobacter pylori infection confirmed by a positive Rapid Urease Test (RUT) or histological findings from endoscopic biopsy suggestive of H. pylori presence.
3. Both male and female participants are eligible for inclusion.
4. Patients will have a similar type of antibiotic and PPI therapy throughout the study. 
 
ExclusionCriteria 
Details  1. Current or recent (within 45 days) antibiotic therapy.
2. Presence of any co-existing chronic gastrointestinal (GI) disorder, or significant hepatic, renal, or cardiac disease.
3. Diagnosis of any form of cancer.
4. Current use of proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, probiotic supplements or medications known to interfere with H. pylori eradication regimen.
5. History of prior gastrointestinal surgery.
6. Women who are pregnant or breastfeeding.
7. Ongoing use of hormonal drugs.
8. Known allergy or hypersensitivity to any of the antibiotics planned for use in the study protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to determine the efficacy of an adjunctive probiotic regimen for Helicobacter pylori infection. The primary endpoints, assessed at Day 0 and Day 61, by RUT(on 0th day), GSRS, CBC, CRP and stool antigent test (on 61st day). The study will compare these outcomes between the group receiving standard antibiotics and PPI treatment along with a probiotic capsule for 60 days and the control group which receive only standard antibiotics and PPI treatment.  At baseline (0th day) and at 61st day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/12/2025 
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)   Open to Recruitment 
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  
This is a randomized, controlled clinical trial designed to assess the efficacy and safety of an adjunctive probiotic therapy in patients with Helicobacter pylori infection. A total of 60 eligible patients (as per inclusion and exclusion criteria) will be enrolled and randomly assigned in a 1:1 ratio using a computer-generated sequence to one of two treatment groups. For eradication of H. pylori infection, the control group (n = 30) will receive only the standard antibiotic and PPI regimen, while the intervention group (n = 30) will receive the same standard antibiotic and PPI treatment supplemented with a daily probiotic capsule for 60 days. The probiotic capsule contains a total of 45×10^9 Colony Forming Units (CFU) of a multi-strain formulation including Lactobacillus paracasei DSM 24733, Lactobacillus plantarum DSM 24730, Lactobacillus acidophilus DSM 24735, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734, Bifidobacterium longum DSM 24736, Bifidobacterium infantis DSM 24737, Bifidobacterium breve DSM 24732, and Streptococcus thermophilus DSM 24731. Throughout the study, participants will be closely monitored, with adherence assessed via the Simplified Medication Adherence Questionnaire (SMAQ) and Adverse Event Diary during the entire study. In addition, formal assessments will be performed at baseline (Day 0) and at the end of follow-up on Day 61. These assessments will include the Gastrointestinal Symptom Rating Scale (GSRS), UGI, Complete Blood Count (CBC), C-Reactive Protein (CRP), and Stool Antigen Test levels to compare outcomes between the two groups.
 
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