- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05701683
IMPROVEMENT in ERADICATION of H-PYLORI INFECTION
IMPROVEMENT in ERADICATION of H-PYLORI INFECTION With ADDITION of LACTOBACILLUS REUTERI
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Mehreen Akmal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ERADICATION of H-PYLORI INFECTION with ADDITION of LACTOBACILLUS REUTERI
In experimental group, patients receiving clarithromycin based sequential therapy with LACTOBACILLUS REUTERI
|
Experimental group receiving Lactobacillus Reuteri Probiotic with sequential therapy
Other Names:
|
NO_INTERVENTION: ERADICATION of H-PYLORI INFECTION without LACTOBACILLUS REUTERI
control group included patients who received clarithromycin based sequential therapy alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication rate
Time Frame: 8 weeks after therapy
|
eradication of helicobacter pylori infection after 8 weeks of completion of therapy
|
8 weeks after therapy
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Eslami M, Yousefi B, Kokhaei P, Jazayeri Moghadas A, Sadighi Moghadam B, Arabkari V, Niazi Z. Are probiotics useful for therapy of Helicobacter pylori diseases? Comp Immunol Microbiol Infect Dis. 2019 Jun;64:99-108. doi: 10.1016/j.cimid.2019.02.010. Epub 2019 Mar 5.
- Emara MH, Mohamed SY, Abdel-Aziz HR. Lactobacillus reuteri in management of Helicobacter pylori infection in dyspeptic patients: a double-blind placebo-controlled randomized clinical trial. Therap Adv Gastroenterol. 2014 Jan;7(1):4-13. doi: 10.1177/1756283X13503514.
- Yang C, Liang L, Lv P, Liu L, Wang S, Wang Z, Chen Y. Effects of non-viable Lactobacillus reuteri combining with 14-day standard triple therapy on Helicobacter pylori eradication: A randomized double-blind placebo-controlled trial. Helicobacter. 2021 Dec;26(6):e12856. doi: 10.1111/hel.12856. Epub 2021 Oct 10.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0493-2019-LNH-ERC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on Lactobacillus Reuteri Probiotic
-
Sahlgrenska University Hospital, SwedenBioGaia ABCompleted
-
Azienda Socio Sanitaria Territoriale degli Spedali...RecruitingPeriodontal DiseasesItaly
-
University of ValenciaCompleted
-
Universiti Kebangsaan Malaysia Medical CentreY.S.P. Industries (M) Sdn. Bhd, Menara LGB, Taman Tun Dr Ismail, 60000 Kuala...CompletedHelicobacter Pylori InfectionMalaysia
-
BioGaia ABHopital Universitaire Robert-Debre; Association Clinique Thérapeutique Infantile... and other collaboratorsWithdrawnInfantile ColicFrance
-
Colombian Neonatal Research NetworkVanderbilt University; Instituto Colombiano para el Desarrollo de la Ciencia...Terminated
-
Tulane University School of MedicineJohns Hopkins Bloomberg School of Public Health; National Center for Complementary... and other collaboratorsCompleted
-
Vastra Gotaland RegionBioGaia ABCompleted
-
Tulane University School of MedicineJohns Hopkins Bloomberg School of Public Health; National Center for Complementary... and other collaboratorsCompleted
-
Case Western Reserve UniversityBioGaia ABCompletedAntibiotic-associated Diarrhea | Clostridium DifficileUnited States