NCT05701683

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 18, 2023

Last Update Submit

February 7, 2023

Conditions

Helicobacter Pylori Infection

Keywords

Lactobacillus reuteriHelicobacter pyloriDyspepsiaEradication Therapy

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    eradication of helicobacter pylori infection after 8 weeks of completion of therapy

    8 weeks after therapy

Study Arms (2)

ERADICATION of H-PYLORI INFECTION with ADDITION of LACTOBACILLUS REUTERI

EXPERIMENTAL

In experimental group, patients receiving clarithromycin based sequential therapy with LACTOBACILLUS REUTERI

Drug: Lactobacillus Reuteri Probiotic

ERADICATION of H-PYLORI INFECTION without LACTOBACILLUS REUTERI

NO INTERVENTION

control group included patients who received clarithromycin based sequential therapy alone

Interventions

Lactobacillus Reuteri ProbioticDRUG

Experimental group receiving Lactobacillus Reuteri Probiotic with sequential therapy

Also known as: sequential therapy with Lactobacillus Reuteri Probiotic
ERADICATION of H-PYLORI INFECTION with ADDITION of LACTOBACILLUS REUTERI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehreen Akmal

Karachi, Sindh, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 31174707RESULT

  • 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.

    PMID: 24381643RESULT

  • 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.

    PMID: 34628695RESULT

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehreen Akmal, MBBS

    Liaquat National Hospital & Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

November 15, 2019

Primary Completion

November 20, 2021

Study Completion

December 31, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)