NCT01593592

Brief Summary

Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 17, 2015

Completed
Last Updated

August 17, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

May 5, 2012

Results QC Date

March 7, 2015

Last Update Submit

July 19, 2015

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriLactobacillus reuteridyspeptic patientseradication

Outcome Measures

Primary Outcomes (1)

  • Eradication of H Pylori Infection 4 Weeks After Completion of Therapy

    H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.

    4 weeks therapy

Secondary Outcomes (2)

  • Severe Adverse Effects to the Used Medications and Dietary Supplements.

    4 weeks

  • The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.

    8 weeks

Study Arms (2)

Lactobacillus reuteri group

EXPERIMENTAL

The active group that will receive the standard triple therapy and Lactobacillus reuteri

Dietary Supplement: Lactobacillus reuteriDrug: OmeprazoleDrug: AmoxicillinDrug: Clarithromycin

Control group

PLACEBO COMPARATOR

The control group that will receive the standard triple therapy and placebo

Dietary Supplement: PlaceboDrug: OmeprazoleDrug: AmoxicillinDrug: Clarithromycin

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.

Lactobacillus reuteri group
PlaceboDIETARY_SUPPLEMENT

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.

Control group
OmeprazoleDRUG

All patients will receive omeprazole 20 mg b.i.d for 2 week

Control groupLactobacillus reuteri group
AmoxicillinDRUG

amoxicillin 1000 mg b.i.d for 2 weeks

Control groupLactobacillus reuteri group
ClarithromycinDRUG

clarithromycin 500mg b.i.d for 2 weeks

Control groupLactobacillus reuteri group

Eligibility Criteria

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

You may qualify if:

  • Age: 18-60 years
  • Any sex
  • Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
  • Good mentality to understand aim, benefits and steps of the study
  • Assumed availability during the study period
  • Written informed consent

You may not qualify if:

  • Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.
  • Patients with malignancy.
  • Patients with gall bladder disorders.
  • Patients with peptic ulcer.
  • Patients with prior upper GIT surgery.
  • Patients with probiotics therapy in the last one month.
  • Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
  • Patients with known allergy to the used medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Links

MeSH Terms

Interventions

OmeprazoleAmoxicillinClarithromycin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesErythromycinMacrolidesPolyketidesLactones

Limitations and Caveats

no limitations

Results Point of Contact

Title
Dr Mohamed Emara
Organization
Tropical Medicine Departement, Faculty of Medicine, Zagazig University, Egypt
emara_20007@yahoo.com
+2 0100 272 4482

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Hepatogastroenterology

Study Record Dates

First Submitted

May 5, 2012

First Posted

May 8, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Last Updated

August 17, 2015

Results First Posted

August 17, 2015

Record last verified: 2015-07

Locations

EG(1)