| 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
|
|
|
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
|
|
|
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
|
|
|
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. |