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

Sponsor
BioGaia AB (Industry)
Overall Status
Terminated
CT.gov ID
NCT01498666
Collaborator
Sprim CRO, Italia (Other)
9
Enrollment
2
Locations
2
Arms
16
Duration (Months)
4.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Dietary Supplement: L. reuteri protectis
  • Dietary Supplement: Placebo tablet
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: L. reuteri protectis tablets

one tablet a day for 4 weeks

Dietary Supplement: L. reuteri protectis
1 tablet once daily for 4 weeks
Placebo Comparator: Placebo tablet

one tablet a day for 4 weeks

Dietary Supplement: Placebo tablet
1 tablet once daily for 4 weeks
Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary endpoint [4 weeks]

      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

    1. Secondary endpoint [56 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 AO "San Paolo" Milano Italy 201442
    2 AO Niguarda Ca' granda Milan Italy 20162

    Sponsors and Collaborators

    • BioGaia AB
    • Sprim CRO, Italia

    Investigators

    • Principal Investigator: Costantino DeGiacomo, MD, Niguarda Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioGaia AB
    ClinicalTrials.gov Identifier:
    NCT01498666
    Other Study ID Numbers:
    • Q-PRE-0111-CLI-018
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Abdominal Pain

    Study Results

    No Results Posted as of Jun 2, 2021