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CTRI Number  CTRI/2026/01/102363 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of bismuth quadruple therapy with bacillus clausii UBBC-07 and zinc carnosine for helicobacter pylori eradication: a double blind, parallel arm, randomized controlled trial 
Scientific Title of Study   Efficacy of bismuth quadruple therapy with bacillus clausii UBBC-07 and zinc carnosine for helicobacter pylori eradication: a double blind, parallel arm, randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaneet Jearth 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  2251
FIRST FLOOR
Chandigarh
CHANDIGARH
160036
India 
Phone  08427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaneet Jearth 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  2251
FIRST FLOOR
Chandigarh
CHANDIGARH
160036
India 
Phone  08427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vaneet Jearth 
Designation  Associate Professor 
Affiliation  Postgraduate Institute of Medical Education and Research 
Address  2251
FIRST FLOOR
Chandigarh
CHANDIGARH
160036
India 
Phone  08427550317  
Fax    
Email  vaneet.jearth@gmail.com  
 
Source of Monetary or Material Support  
Unique Biotech Limited 
 
Primary Sponsor  
Name  Unique Biotech Limited 
Address  Plot No. 2, Phase-II, M.N. Park, Kolthur Village, Shameerpet Mandal, Hyderabad-500101, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Vaneet Jearth  Postgraduate Institute of Medical Education and Research  Sector 12 Chandigarh
Chandigarh
CHANDIGARH 
08427550317

vaneet.jearth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K293||Chronic superficial gastritis, (2) ICD-10 Condition: K30||Functional dyspepsia, (3) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bacillus clausii UBBC-07 and zinc carnosine (a chelated compound composed of 77% of L-carnosine and 23% of elemental zinc)  The investigational product—a combination of Bacillus clausii UBBC-07 (4 billion CFU) and Zinc Carnosine (17 mg elemental zinc)—will be given in capsule form (to be taken once daily). Each participant will receive a drug or similar-looking placebo for four weeks (two phases). (Day 1-14) Probiotic or similar-looking Placebo capsules + Bismuth Quadruple therapy (Day 15-28) Only probiotic or similarly looking placebo capsules. Each participant will also receive Bismuth Quadruple Therapy for the first 14 days Clarithromycin 500 mg – 1 tab BID × 14 days Amoxicillin 500 mg – 2 caps BID × 14 days Esomeprazole 40 mg – 1 tab BID × 14 days Bismuth subcitrate 120 mg – 1-tab QID × 14 days  
Comparator Agent  Placebo  Each participant will receive a drug or similar-looking placebo for four weeks (two phases). (Day 1-14) Probiotic or similar-looking Placebo capsules + Bismuth Quadruple therapy (Day 15-28) Only probiotic or similarly looking placebo capsules. Each participant will also receive Bismuth Quadruple Therapy for the first 14 days Clarithromycin 500 mg – 1 tab BID × 14 days Amoxicillin 500 mg – 2 caps BID × 14 days Esomeprazole 40 mg – 1 tab BID × 14 days Bismuth subcitrate 120 mg – 1-tab QID × 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients tested positive for H. pylori on endoscopy by either RUT or HPE.
Written informed consent of the subject to participate.
PatientS above 18 years of age will be included in the study. 
 
ExclusionCriteria 
Details  Previous intolerance and/or adverse reactions to probiotics or the use of these products within the preceding 1 month.
Pregnancy or lactation.
Major systemic disease (e.g. heart failure, renal failure, malignant tumors, liver cirrhosis, etc.)
Previous or current significant psychiatric co-morbidity
Use of antibiotics in the preceding 1 month.
Patient on any specific diet.
Patient on any immunosuppressant drugs
Patients who were unwilling to participate voluntarily in the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Eradication rates of H. pylori in both the groups  Eradication rates of H. pylori in both the groups 
 
Secondary Outcome  
Outcome  TimePoints 
Overall adverse events  2 ,4 ,6 WEEKS 
Compliance of therapy  2 AND 4 WEEKS 
Changes in dyspeptic symptoms  2,4 AND 6 WEEKS 
Quality of Life  2,4 and 6 WEEKS 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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   Phase 3 
Date of First Enrollment (India)   01/03/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Standard regimens for H. pylori infection typically involve triple or quadruple therapy. However, rising antibiotic resistance, adverse effects, and patient non-compliance significantly limit the success rates of these regimens. Probiotics have emerged as a promising adjunct or alternative strategy for H. pylori management. Among the wide strains of probiotics, Bacillus clausii has been shown to have a promising effect in reducing the side effects of H. pylori treatment, as previously studied . In another meta-analysis published in 2014, it is reported that probiotics formulated with specific Bacillus clausii strains are known to be more effective in eradicating H. pylori infection in patients. There are only a few studies on zinc carnosine-based modified bismuth quadruple therapy in H. pylori eradication, and no study has been reported in India yet. As an effective treatment for H. pylori infection, a probiotic formulated with zinc carnosine could be a significant factor in eradicating H. pylori in view of the very high antibiotic resistance reported from India to all first-line antibiotics. We hypothesize that administering probiotics during H. pylori eradication, based on limited available data, may mitigate adverse effects associated with the medication while simultaneously enhancing the eradication rate and compliance with the treatment. Further, safety data suggests it to be safe. Therefore, we aim to plan a randomized controlled trial to evaluate the role of Bacillus clausii UBBC-07 formulated with zinc carnosine in H. pylori eradication.

 
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