| CTRI Number |
CTRI/2024/09/074495 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori. |
|
Scientific Title of Study
|
Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori |
| 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 Mohinish Chhabra |
| Designation |
Director Department of Gastroenterology |
| Affiliation |
Fortis hospital, Mohali |
| Address |
Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Rupnagar PUNJAB 160062 India |
| Phone |
9814057593 |
| Fax |
|
| Email |
Chhabramohinish@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankush Bansal |
| Designation |
Senior Resident |
| Affiliation |
Fortis Hospital,Mohali |
| Address |
Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Rupnagar PUNJAB 160062 India |
| Phone |
9988381946 |
| Fax |
|
| Email |
ankushbansalab19@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ankush Bansal |
| Designation |
Senior Resident |
| Affiliation |
Fortis hospital, Mohali |
| Address |
Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Rupnagar PUNJAB 160062 India |
| Phone |
9988381946 |
| Fax |
|
| Email |
ankushbansalab19@yahoo.com |
|
|
Source of Monetary or Material Support
|
| department of gastroenterology , fortis hospital, sector 62, mohali |
|
|
Primary Sponsor
|
| Name |
NBE |
| Address |
National Board of Examinations, Dwarka sector 9 Rd,PSP area, New Delhi,India
Pin code 110075 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankush Bansal |
fortis hospital |
Room no. 127, Department of Gastroenterology
Fortis Hospital
Sector 62
Mohali Rupnagar PUNJAB |
9988381946
ankushbansalab19@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K296||Other gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18-80 years
2. All symptomatic patients with dyspepsia (ROME criteria 4)with proven h pylori on biopsy/
urea breath test/stool for h pylori
ROME 4 CRITERIA
1. One or more of the following:
1. Bothersome postprandial fullness
2. Bothersome early satiation
3. Bothersome epigastric pain
4. Bothersome epigastric burning
AND
2. No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
(Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis)
|
|
| ExclusionCriteria |
| Details |
Patients with the following findings will be excluded from the study
1. H/o gastric surgery such as partial gastrectomy
2. H/o allergy of drugs used in the study
3. Pregnant and lactating females
4. Alcohol or drug addiction
5. Lack of informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of eradication rate of H. Pylori between the two regimens. |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
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)
|
07/10/2024 |
| 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)
|
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
|
Helicobacter pylori (H. pylori) infection is a general condition that is usually lifelong, with a prevalence reaching approximately 50% worldwide; in China, the prevalence has recently reached 44%. In December 2021, th.e U.S. Department of Health and Human Services listed chronic H. pylori as a clear carcinogen in the 15th report on carcinogens. It has also been proven to be closely related to multiple gastrointestinal (GI) diseases such as gastric adenocarcinoma, peptic ulcer (gastric and duodenal ulcer), chronic gastritis, and mucosa-associated lymphoid tissue (MALT) lymphoma. Successful H. pylori eradication would not only benefit individuals by improving histologic gastritis, preventing gastric carcinogenesis, and reducing the risk of serious complications but also block transmission and alleviate future medical expenses. However, H. pylori eradication rates have been decreasing in recent years, while the antibiotic resistance rate continues to increase. Hence vonoprazan a novel potassium channel blocker, may be effective as a component of H. pylori eradication therapy. Vonoprazan therapy is approved for H pylori
eradication and is currently being used in practice. We at our centre prescribe
both the regimens. Patients will be prescribed treatment for 14 days.
Confirmation of H. Pylori eradication will be done by stool H pylori antigen
test or urea breadth test at 4 weeks at the end of h pylori treatment. Data of
the patients taking quadruple therapy and vonoprazan therapy will be collected.
Then H.Pylori eradication rate of both
the regimens will be calculated and then will be compared |