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

Not Applicable

Terminated

• Conditions: Abdominal Pain
• Interventions: Dietary Supplement: L. reuteri protectis; Dietary Supplement: Placebo tablet

• Registration Number: NCT01498666
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-23
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-12
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L. reuteri protectis tablets	L. reuteri protectis	one tablet a day for 4 weeks
Placebo tablet	Placebo tablet	one tablet a day for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

AO Niguarda Ca' granda; 🇮🇹 Milan, Italy

AO "San Paolo"; 🇮🇹 Milano, Italy