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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Aghia Sophia Children's Hospital of Athens
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Alexandra Papadopoulou, Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier:
NCT01719107
First received: October 28, 2012
Last updated: June 22, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Functional Abdominal Pain (FAP) in Children
Dietary Supplement: L. reuteri DSM 17938 chewable tablets
Dietary Supplement: Placebo chewable tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children

Resource links provided by NLM:


Further study details as provided by Aghia Sophia Children's Hospital of Athens:

Primary Outcome Measures:
  • Abdominal pain frequency and severity over the 4-week treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Reduction in pain frequency and intensity over the 8-week study period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Reduction in pain frequency measured by a subject diary in the L. reuteri group expressed as area under the L. reuteri pain-frequency curve compared to placebo over the initial 2 weeks of the treatment period as well as over the whole study period.

    Reduction in pain intensity, measured by the face score system of Wong-Baker at day 14, end of treatment (day 28), and end of follow-up period (day 56) vs baseline. Area under the pain-intensity curve for Weeks 1-4 and Weeks 1-2 will be compared.


  • Reduction in other GI symptoms over the whole study period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction in other GI symptoms as measured by Gastrointestinal Symptom Rating Scoring system. Time points: baseline, day 14, end of treatment and end of follow-up, in the L. reuteri group vs. placebo.

  • Days of absence from school and other activities due to abdominal pain over the whole study period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The number of days of absence from school and other activities due to abdominal pain will be compared between the L. reuteri group vs placebo.

  • Reduction in absence from work by parents over the whole study period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    he number of days of absence from work by parents due to abdominal pain of the child will be compared between the L. reuteri group vs placebo.

  • Safety outcome over the whole study period [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    The number of adverse events will be observed and recorded during the entire study period


Estimated Enrollment: 106
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L. reuteri DSM 17938 chewable tablets
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
2 chewable tablets with breakfast for 4 weeks
Placebo Comparator: Placebo chewable tablets
The placebo study product consists of an identical formulation in all respects except that the live bacteria are excluded.
Dietary Supplement: Placebo chewable tablets
2 chewable tablets with breakfast for 4 weeks

Detailed Description:

This is a randomized, double-blind, placebo-controlled study. Subjects between of 5-16 years of age with FAP as defined in the Rome III criteria and with pain severity of at least 40 mm on a 100 mm VAS scale and pain frequency of at least 1 episode per week over the preceding 8 weeks will be recruited. In accordance to the specific Rome III criteria for inclusion, FAP is defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities.

A study questionnaire to record pain and other gastrointestinal symptoms will be used.

One-hundred and six (106) Subjects will be randomized to receive either dietary supplementation with L. reuteri DSM 17938 (2 chewable tablets with breakfast), or the same number of comparable placebo tablets, for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed by the GSRS (Gastrointestinal Symptom Rating Score).

Subjects/caregivers will be instructed to maintain the usual diet throughout the study, but not to consume other probiotics (foods or supplements) during the entire study period.

The symptoms diary will be completed daily by the parents and will report information on the frequency of pain episodes, location of pain, presence or absence of associated symptoms, need to take medication for pain and interference with normal activities. The intensity of the symptoms will be assessed by using the Wong-Baker Faces scale.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be recruited according to the following inclusion criteria:

  • 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

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719107

Contacts
Contact: Alexandra Papadopoulou, Hon. Prof. Dr. med. +302107726408 papadop5@otenet.gr
Contact: Maria Maragoudaki, Dr +302107467945 mariamariaki@gmail.com

Locations
Greece
Athens Children's Hospital "AGIA SOPHIA" Recruiting
Athens, Attica, Greece, 11527
Contact: Alexandra Papadopoulou, Hon. Prof. Dr. med.    +302107467945    papadop5@otenet.gr   
Contact: Maria Maragoudaki, Dr    +302107467945    mariamariaki@gmail.com   
Principal Investigator: Alexandra Papadopoulou, Consultant Hon. Prof. Dr. med.         
Sub-Investigator: Maria Maragoudaki, Dr         
Sub-Investigator: George Houliaras, Dr         
Sub-Investigator: Panagiota Tsiligianni, Mrs         
Poland
University of Warsaw, Department of Pediatrics Recruiting
Warsaw, Poland
Contact: Hania Szajewska, Prof       hania@ipgate.pl   
Contact: Andrea Horvath       andrea.hania@gmail.com   
Principal Investigator: Hania Szajewska, Prof         
Sub-Investigator: Andrea Horvath, Dr         
Slovenia
University of Ljubljana, Children's Hospital, Department of Gastroenterology Recruiting
Ljubljana, Slovenia
Contact: Rok Orel, Ass Prof       rok.orel@kclj.si   
Principal Investigator: Rok Orel, Ass Prof         
Sponsors and Collaborators
Aghia Sophia Children's Hospital of Athens
BioGaia AB
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Alexandra Papadopoulou, Consultant in Pediatrics, Honorary Professor Dr. med., Aghia Sophia Children's Hospital of Athens
ClinicalTrials.gov Identifier: NCT01719107     History of Changes
Other Study ID Numbers: CSUB0003
Study First Received: October 28, 2012
Last Updated: June 22, 2013
Health Authority: Ethics Committee of the Children's Hospital "P & A Kyriakou", Athens, Greece ':'

Keywords provided by Aghia Sophia Children's Hospital of Athens:
Functional abdominal pain
Probiotics
Lactobacilus reuteri

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 26, 2014