The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children

NCT02645201 | Withdrawn

• 1 other identifier: Gastrus01
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 5

Brief Summary

The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain. Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.

Conditions

Helicobacter Infections

Keywords

probiotic

Outcome Measures

Primary Outcomes (1)

• to compare changes of frequency and type of adverse events (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency) in probiotic and placebo arm at different time frames

  symptom diary (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency-frequency)

  at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)

Secondary Outcomes (1)

• to compare the number of patients with succesful eradication of Helicobacter pylori infection in probiotic and placebo arm

  8-12 weeks after eradication therapy

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Children in probiotic group will receive chewable tablets containing 4x108 CFU of Gastrus. Subjects will take 1 tablet twice a day for 21 days

Dietary Supplement: Gastrus

Placebo

PLACEBO COMPARATOR

Children in placebo group will receive placebo tablets of similar appearance and taste as Gastrus tablets. Subjects will take 1 placebo tablet twice a day for 21 days

Other: Placebo

Interventions

Gastrus DIETARY_SUPPLEMENT

to compare Gastrus 4x108 tbl twice a day to placebo tbl

Also known as: Lactobacillus reuteri (ATC 55730 and ATCC PTA 6457)

Probiotic

Placebo OTHER

to compare Gastrus 4x108 tbl twice a day to placebo tbl

Also known as: Placebo pills

Placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Either sex age between 5 (\>15 kg) - 18 years.
• Confirmed H. pylori infection (two out of four invasive methods positive (rapid urease test/histology/culture/PCR test) with positive culture and susceptibility testing for clarithromycin and metronidazole).
• Able to be informed (patient/parents) of the nature of the study and willing to give written informed consent (consent from the parents must be obtained before any study-related procedures are conducted and assent of the child if older than 10 years).
• Treatment naive children with H. pylori infection.

You may not qualify if:

• Significant acute or chronic GE disease (IBD, symptomatic coeliac disease…)
• Known allergies to used antibiotics, proton pump inhibitors or probiotics
• Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.
• Having received proton pump inhibitors during the previous two weeks.
• Having received probiotic therapy during the previous 14 days.
• Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)
• Severe acquired or primary immunodeficiency.
• Children with gastric or duodenal peptic ulcer disease

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (5)

Queen Fabiola Children's Hospital

Brussels, Belgium

Location

Children's Hospital Zagreb

Zagreb, 10000, Croatia

Location

Dr. von Hauner Children's Hospital

Munich, Germany

Location

Kaplan Medical Center

Rehovot, Israel

Location

University Children's Hospital

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Francavilla R, Polimeno L, Demichina A, Maurogiovanni G, Principi B, Scaccianoce G, Ierardi E, Russo F, Riezzo G, Di Leo A, Cavallo L, Francavilla A, Versalovic J. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study. J Clin Gastroenterol. 2014 May-Jun;48(5):407-13. doi: 10.1097/MCG.0000000000000007.

  PMID: 24296423 RESULT

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Matjaz Homan, MD PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. Tadej Battelino, MD PhD

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

BE (1); CR (1); SL (1); IL (1); DE (1)