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LGG for Prevention of Infectious Complications During PPI Treatment in Children

NCT ID: NCT01782118

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.

Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.

Study design: Randomized, double-blind, placebo controlled trial.

Detailed Description

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Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.

Conditions

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Gastroesophageal Reflux Disease Gastrointestinal Infections Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lactobacillus GG

Lactobacillus GG given for six weeks two times per day.

Group Type EXPERIMENTAL

Lactobacillus GG

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo two times per day for six weeks

Group Type PLACEBO_COMPARATOR

Lactobacillus GG

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Lactobacillus GG

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dicoflor

Eligibility Criteria

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Inclusion Criteria

* age \<5,
* clinical symptoms of GERD
* treatment with proton pump inhibitors
* signed informed consent

Exclusion Criteria

* treatment with PPI within the last 4 weeks for at least 2 weeks
* administration of probiotics within 7 days prior to the study
* acute or chronic respiratory tract infections
* acute or chronic gastrointestinal tract infections
* neurological disorders
* immunodeficiency
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Hanna Szajewska

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Katarzyna Krenke, MD

Role: CONTACT

Phone: +48224523204

Email: [email protected]

Piotr Dziechciarz, MD

Role: CONTACT

Phone: +48224523292

Email: [email protected]

Facility Contacts

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Katarzyna Krenlke, MD

Role: primary

Piotr Dziechciarz, MD

Role: backup

Other Identifiers

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1/2013

Identifier Type: -

Identifier Source: org_study_id