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CTRI Number  CTRI/2026/01/100661 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 06/07/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare the Effectiveness of Two Vonoprazan-Based Treatment Options for Helicobacter pylori Infection 
Scientific Title of Study   Comparison of Vonoprazan dual therapy with Vonoprazan Bismuth-based triple therapy in Helicobacter pylori eradication – A Randomized Controlled Trial 
Trial Acronym  PILL-B Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harrison Gabriel G B 
Designation  Senior Resident  
Affiliation  Government Kilpauk Medical college  
Address  Department of Medical Gastroenterology Government Kilpauk Medical college and Hospital Kilpauk

Chennai
TAMIL NADU
600010
India 
Phone  8668011644  
Fax    
Email  harrisonsrv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Chezhian 
Designation  Senior Resident  
Affiliation  Government Kilpauk Medical college  
Address  Department of Medical Gastroenterology Government Kilpauk Medical college and Hospital Kilpauk

Chennai
TAMIL NADU
600010
India 
Phone  9443206141  
Fax    
Email  ddhdkmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Harrison Gabriel G B 
Designation  Senior Resident  
Affiliation  Government Kilpauk Medical college  
Address  Department of Medical Gastroenterology Government Kilpauk Medical college and Hospital Kilpauk

Chennai
TAMIL NADU
600010
India 
Phone  8668011644  
Fax    
Email  harrisonsrv@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Government Kilpauk Medical college  
Address  Government Kilpauk Medical college and Hospital,Poonamalle high road Kilpauk chennai 600010 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Biomiicron Pharma india Pvt Ltd  Old no.18, New No.32,Dr Ambedkar Rd, , Kodambakkam, Chennai- 600024 Tamilnadu 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harrison Gabriel   Government Kilpauk medical College   Department of medical Gastroenterology Government Kilpauk Medical college and Hospital Kilpauk
Chennai
TAMIL NADU 		 8668011644

harrisonsrv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Kilpauk Medical college Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K296||Other gastritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vonoprazan Bismuth Based triple Therapy   Vonoprazan 20 mg BD + Amoxicillin 750mg TDS + Bismuth subcitrate 240mg BD Duration: 14 days 
Comparator Agent  Vonoprazan Dual Therapy  Vonoprazan 20 mg BD + Amoxicillin 1000mg TDS Duration 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 70 years
Confirmed H pylori infection by Rapid Urease Test
Treatment Naive for H pylori
 
 
ExclusionCriteria 
Details  Known Allergy to study drugs
Previous H pylori eradication therapy
Pregnancy or lactation
Patients on NSAIDS
Severe hepatic or renal impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the eradication rates of H. pylori between Vonoprazan Dual therapy and Vonoprazan bismuth based Triple therapy  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1)Adherence to treatment Regimen
2)To evaluate adverse drug events
 		 6 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/02/2026 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   Helicobacter pylori is a gram negative bacterium that colonizes the gastric mucosa and is a major cause of chronic gastritis peptic ulcer disease MALT lymphoma and gastric adenocarcinoma. Eradication of H pylori reduces disease related complications and is a key component of gastrointestinal disease management. However increasing antibiotic resistance poor compliance and inadequate acid suppression with proton pump inhibitors have reduced treatment success rates.

Vonoprazan is a potassium competitive acid blocker that provides rapid and sustained gastric acid suppression and is not affected by CYP2C19 genetic variability. It has shown superior or comparable efficacy to proton pump inhibitor based regimens in H pylori eradication. Vonoprazan has been approved in India in May 2024 as an adjuvant for H pylori eradication.

Although vonoprazan based dual therapy and vonoprazan based bismuth regimens have demonstrated high eradication rates direct randomized comparisons between these regimens are limited. Differences in antibiotic exposure tolerability and adherence warrant systematic evaluation.

This randomized controlled trial PILL-B Trial ( Potassium-competitive acid blocker (vonoprazan) In Low-pilL burden with Bismuth vs dual therapy)aims to compare the efficacy and safety of vonoprazan dual therapy versus vonoprazan bismuth triple therapy for eradication of H pylori infection. Secondary objectives include assessment of treatment adherence and adverse event profile.
 
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