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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01498666
Recruitment Status : Terminated (The recruitment rate was too slow according to study protocol and agreement.)
First Posted : December 23, 2011
Last Update Posted : December 3, 2013
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
BioGaia AB

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

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 Type : Interventional  (Clinical Trial)
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 : December 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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 Name: Placebo

Primary Outcome Measures :
  1. Primary endpoint [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01498666

AO "San Paolo"
Milano, Italy, 201442
AO Niguarda Ca' granda
Milan, Italy, 20162
Sponsors and Collaborators
BioGaia AB
Sprim Advanced Life Sciences
Principal Investigator: Costantino DeGiacomo, MD Niguarda Hospital

Responsible Party: BioGaia AB Identifier: NCT01498666     History of Changes
Other Study ID Numbers: Q-PRE-0111-CLI-018
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive