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

NCT01719107 | Completed DMC

• 1 other identifier: CSUB0003
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Functional abdominal pain; Probiotics; Lactobacilus reuteri

Outcome Measures

Primary Outcomes (1)

• Abdominal pain frequency and severity over the 4-week treatment period.

  Reduction in pain frequency measured by a subject diary, in the L. reuteri DSM 17938 group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri DSM 17938 vs placebo over the treatment period. Reduction in pain severity is assessed using the face score system of Wong-Baker at day 14 and at the end of treatment (day 28)vs. baseline. Area under the pain-intensity curve will be assessed for Weeks 1-4 and Weeks 1-2

  4 weeks

Secondary Outcomes (5)

• Reduction in pain frequency and intensity over the 8-week study period

  8 weeks

• Reduction in other GI symptoms over the whole study period

  8 weeks

• Days of absence from school and other activities due to abdominal pain over the whole study period

  8 weeks

• Reduction in absence from work by parents over the whole study period

  8 weeks

• Safety outcome over the whole study period

  8 weeks

Study Arms (2)

L. reuteri DSM 17938 chewable tablets

ACTIVE COMPARATOR

The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri DSM 17938 is 1x108 live bacteria (CFU)/tablet.

Dietary Supplement: L. reuteri DSM 17938 chewable tablets

Placebo chewable tablets

PLACEBO COMPARATOR

The placebo study product consists of an identical formulation in all respects except that the live bacteria are excluded.

Dietary Supplement: Placebo chewable tablets

Interventions

L. reuteri DSM 17938 chewable tablets DIETARY_SUPPLEMENT

2 chewable tablets with breakfast for 4 weeks

L. reuteri DSM 17938 chewable tablets

Placebo chewable tablets DIETARY_SUPPLEMENT

2 chewable tablets with breakfast for 4 weeks

Placebo chewable tablets

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• FAP (Functional Abdominal Pain) according to Rome III criteria for Child/Adolescent; 1 or more abdominal pain episodes per week over the past 8 weeks
• Informed consent by study participant and at least one parent/legal guardian;
• Age of 5-16 years;
• Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
• Pain frequency of at least 1 or more episodes per week over the preceding 8 weeks;
• Ability to understand and comply with the requirements of the trial;
• Stated availability throughout the study period

You may not qualify if:

• Subjects presenting with one or more of the following criteria will be excluded from participation in the study:
• Chronic illness;
• Surgery of gastrointestinal tract
• Any symptoms/signs of organic disease and/or any abnormal results of laboratory assays (total blood count, serum glucose, urea, electrolytes, amylase, SGOT, SGPT, anti tTG antibodies, breath H2 test, suggesting disease other than FAP;
• Weight loss of 5% or more in body weight over the preceding 3 months;
• Exposure to any drugs for FAP in the past 2 weeks.
• Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
• Participation in other interventional clinical trials in the past 3 months;
• Subjects with special dietary needs

Sponsors & Collaborators

• Aghia Sophia Children's Hospital of Athens: lead
• BioGaia AB: collaborator

Study Sites (3)

Athens Children's Hospital "AGIA SOPHIA"

Athens, Attica, 11527, Greece

Location

University of Warsaw, Department of Pediatrics

Warsaw, Poland

Location

University of Ljubljana, Children's Hospital, Department of Gastroenterology

Ljubljana, Slovenia

Location

Study Officials

• Alexandra Papadopoulou, Hon. Prof. Dr. med.

  Athens Interconnected Children's Hospitals "AGIA SOPHIA" and "P & A KYRIAKOU"

  PRINCIPAL INVESTIGATOR

• Hania Szajewska, Prof

  Warsaw University

  PRINCIPAL INVESTIGATOR

• Rok Orel, Ass. Prof.

  Ljubljana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Pediatrics, Honorary Professor Dr. med.

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: November 1, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

GR (1); PL (1); SL (1)