IMPROVEMENT in ERADICATION of H-PYLORI INFECTION

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Lactobacillus Reuteri Probiotic

• Registration Number: NCT05701683
• Lead Sponsor: Liaquat National Hospital & Medical College

Brief Summary

Efficacy in terms of H pylori eradication of clarithromycin based sequential therapy with lactobacillus is better than sequential based therapy alone.

Detailed Description

Data Collection:

Subjects attending outpatient in department of Gastroenterology meeting the inclusion \& exclusion criteria in Liaquat National Hospital, Karachi with H. pylori related chronic gastritis with/without peptic ulcers on endoscopy \& gastric biopsy (histopathology) or Stool for H. pylori antigen +ve, or Rapid urease test +ve or Positive Urea Breath Test as per operational definition will be included. For all patients included in this study, we will collect the following information age, gender, duration of the disease.Patients will be divided into two groups randomly, group A and B.In group A (case) patients along with standard sequential therapy :

* Amoxil 1000 mg twice daily for first 5 days

* clarithromycin 500 mg twice daily plus Tinidazole 500 mg twice daily for next 5 days with addition of lactobacillus R 100 mg twice daily in capsule form will be given for 2 weeks. While group B (control) will include patients who have already received standard sequential therapy which is

* Amoxil 1000mg twice daily for first 5 days

* Clarithromycin 500 mg twice daily plus Tinidazole 500 mg twice daily for next 5 days After completion of 6 weeks of proton pump inhibitors (PPI), it will be stopped. As per our protocol for all patients , after 1-2 weeks of stopping PPI stool sample will be collected and will be sent to the laboratory of the institute for helicobacter pylori stool antigen (HPSA).This test is performed as routine to check the success of eradication therapy. H. pylori eradication will be achieved if post treatment HPSA is negative. All demography, clinical history will be recorded by a principal investigator on a predesigned proforma, informed written consent will be taken before enrolment. Exclusion criteria will be followed strictly to avoid confounding variables.

MATERIAL AND METHODS

Study design:

Randomized control study.

Setting:

Study was conducted in Out Patients Department of Gastroenterology, Liaquat National Hospital, Karachi.

Duration: One year after approval of synopsis from hospital ethics committee.

Sample size:

Sample size: Sample size was calculated on the basis of the following eradication rate of H. Pylori with clarithromycin based sequential therapy regimen was= 76%(no relevant statistics available regarding combination of clarithromycin based sequential therapy regimen with lactobacillus Reuteri) Confidence level=95% Bond on error= 6% Sample size (n) = 195 no: of H. Pylori positive Patients in each group, with total of 390 patients Formula n= z2p (1-P) /d2

Inclusion criteria:

* Patients between 18 years to 60 years of age.

* Either gender

* Patients having H. pylori related chronic gastritis with/without peptic ulcers on endoscopy \& gastric biopsy (histopathology) or Stool for H. pylori antigen +ve , or Rapid urease test +ve

Exclusion criteria:

* Pregnant women

* End stage renal disease (GFR \<15 mL/min/)

* Chronic Liver Disease

Data analysis:

Statistical package for Social Sciences (SPSS version 22) was used for data analysis. Frequencies and percentages were computed for qualitative variables like gender, post eradication HPSA (negative/positive). Quantitative variables will be presented as mean ± standard deviation for age and duration of dyspepsia. Effect modifiers like age, gender, duration of dyspepsia were controlled through stratification. Post stratification Chi-square test was used. P value ≤0.05 was considered as significant.

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2021-11-20
• Study Completion: 2022-12-31
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• Patients between 18 years to 60 years of age.
• Either gender
• Patients having H. pylori related chronic gastritis with/without peptic ulcers on endoscopy & gastric biopsy (histopathology) or Stool for H. pylori antigen +ve , or Rapid urease test +ve

Exclusion Criteria

• Pregnant women
• End stage renal disease (GFR <15 mL/min/)
• Chronic Liver Disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERADICATION of H-PYLORI INFECTION with ADDITION of LACTOBACILLUS REUTERI	Lactobacillus Reuteri Probiotic	In experimental group, patients receiving clarithromycin based sequential therapy with LACTOBACILLUS REUTERI

Primary Outcome Measures

Name	Time	Method
Eradication rate	8 weeks after therapy	eradication of helicobacter pylori infection after 8 weeks of completion of therapy

Trial Locations

Locations (1)

Mehreen Akmal; 🇵🇰 Karachi, Sindh, Pakistan