IMPROVEMENT in ERADICATION of H-PYLORI INFECTION
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Lactobacillus Reuteri Probiotic
Intervention type(s): Drug
Intervention description(s): Experimental group receiving Lactobacillus Reuteri Probiotic with sequential therapy
Other intervention name(s): sequential therapy with Lactobacillus Reuteri Probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lactobacillus reuteri; Helicobacter pylori; Dyspepsia; Eradication Therapy