MedTrace Logo

Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children

NCT01719107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-02-23

No results posted yet for this study

Summary

The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP.

Conditions

  • Functional Abdominal Pain (FAP) in Children

Interventions

DIETARY_SUPPLEMENT

L. reuteri DSM 17938 chewable tablets

2 chewable tablets with breakfast for 4 weeks

DIETARY_SUPPLEMENT

Placebo chewable tablets

2 chewable tablets with breakfast for 4 weeks

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Aghia Sophia Children's Hospital of Athens

    lead OTHER

Principal Investigators

  • Alexandra Papadopoulou, Hon. Prof. Dr. med. · Athens Interconnected Children's Hospitals "AGIA SOPHIA" and "P & A KYRIAKOU"

  • Hania Szajewska, Prof · Warsaw University

  • Rok Orel, Ass. Prof. · Ljubljana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Greece
  • Poland
  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01719107 on ClinicalTrials.gov