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Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old (LactoFAP)

This study has been terminated.
(The recruitment rate was too slow according to study protocol and agreement.)
Sponsor:
Collaborator:
Sprim Italia
Information provided by (Responsible Party):
BioGaia AB
ClinicalTrials.gov Identifier:
NCT01498666
First received: December 19, 2011
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).


Condition Intervention Phase
Abdominal Pain
 Dietary Supplement: L. reuteri protectis
Dietary Supplement: Placebo tablet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

Further study details as provided by BioGaia AB:

Primary Outcome Measures:
  • Primary endpoint [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Pain frequency measured by a subject diary, in the L. reuteri Protectis group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri Protectis vs. placebo over the 4-week supplementation period.


Secondary Outcome Measures:
  • Secondary endpoint [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Pain frequency measured by subject diary and expressed as area under the curve, comparing L. reuteri protectis vs. placebo over the initial 2 weeks of the supplementation period. Pain severity measured by the face score system by Wong-Baker at day 14, 28 and 56 (follow up) vs baseline, and area under the curve for weeks 1-4 and 1-2. Treatment success, defined as ≥ 50% reduction in pain frequency in weeks 1-4. Reduction in days of absence from school. Parents' absence from work. Need of rescue medication.


Enrollment: 9
Study Start Date: December 2011
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L. reuteri protectis tablets
one tablet a day for 4 weeks
 Dietary Supplement: L. reuteri protectis
1 tablet once daily for 4 weeks
Other Name: L. reuteri protectis
Placebo Comparator: Placebo tablet
one tablet a day for 4 weeks
 Dietary Supplement: Placebo tablet
1 tablet once daily for 4 weeks
Other Name: Placebo

Detailed Description:

Subject will be asked to consume a tablet every day 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.

  Eligibility

Ages Eligible for Study:   8 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FAP (Functional Abdominal Pain) according to Rome III criteria for
  • Child/Adolescent (Rasquin, 2006);
  • 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 8-14 years;
  • Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
  • Ability to understand and comply with the requirements of the trial;
  • Stated availability throughout the study period.

Exclusion Criteria:

  • Chronic illness;
  • Surgery of Gastrointestinal tract;
  • Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
  • Weight loss of 5% or more in body weight over the preceding 3 months;
  • Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
  • Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
  • 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 clinical trials in the past 3 months;
  • Subjects with anemia;
  • Subjects with special dietary needs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498666

Locations
Italy
AO Niguarda Ca' granda
Milan, Italy, 20162
AO "San Paolo"
Milano, Italy, 201442
Sponsors and Collaborators
BioGaia AB
Sprim Italia
Investigators
Principal Investigator: Costantino DeGiacomo, MD Niguarda Hospital
  More Information

No publications provided

Responsible Party: BioGaia AB
ClinicalTrials.gov Identifier: NCT01498666     History of Changes
Other Study ID Numbers: Q-PRE-0111-CLI-018
Study First Received: December 19, 2011
Last Updated: April 4, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013