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LGG for Prevention of Infectious Complications During PPI Treatment in Children

Primary Purpose

Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections

Status

Unknown status

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Lactobacillus GG

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux Disease

Eligibility Criteria

1 Month - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus GG

Placebo

Arm Description

Lactobacillus GG given for six weeks two times per day.

Placebo two times per day for six weeks

Outcomes

Primary Outcome Measures

Respiratory tract infections

Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention

Gastrointestinal tract infections

Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention

Secondary Outcome Measures

Number of pneumonias

during intervention plus 3 months after termination of the intervention

Adverse events

Number and character of adverse events during intervention plus 3 months after termination of the intervention.

Full Information

NCT ID

NCT01782118

First Posted

January 21, 2013

Last Updated

October 30, 2013

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT01782118

Brief Title

LGG for Prevention of Infectious Complications During PPI Treatment in Children

Official Title

Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactobacillus GG

Arm Type

Experimental

Arm Description

Lactobacillus GG given for six weeks two times per day.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo two times per day for six weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus GG

Other Intervention Name(s)

Dicoflor

Primary Outcome Measure Information:

Title

Respiratory tract infections

Description

Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention

Time Frame

up to 3 months after termination of intervention

Title

Gastrointestinal tract infections

Description

Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention

Time Frame

up to 3 months after termination of intervention

Secondary Outcome Measure Information:

Title

Number of pneumonias

Description

during intervention plus 3 months after termination of the intervention

Time Frame

up to 3 months after termination of intervention

Title

Adverse events

Description

Number and character of adverse events during intervention plus 3 months after termination of the intervention.

Time Frame

up to 3 months after termination of intervention

Other Pre-specified Outcome Measures:

Title

serum level of 25OHD

Time Frame

at 6 weeks

Title

serum level of ferritin

Time Frame

at 6 weeks

Title

Total iron binding capacity

Time Frame

at 6 weeks

Title

serum level of ferrum

Time Frame

at 6 weeks

Title

fecal calprotectin

Time Frame

at 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katarzyna Krenke, MD

Phone

+48224523204

katarzynakrenke@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Piotr Dziechciarz, MD

Phone

+48224523292

piotrdz@hotmail.com

Facility Information:

Facility Name

Medical University of Warsaw

City

Warsaw

ZIP/Postal Code

02-091

Country

Poland

Individual Site Status

Recruiting

Facility Contact: