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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Dietary Supplement: L. reuteri protectis
* Dietary Supplement: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L. reuteri protectis tablets<br>one tablet a day for 4 weeks | Dietary Supplement: L. reuteri protectis<br>* 1 tablet once daily for 4 weeks<br>|
| Placebo Comparator: Placebo tablet<br>one tablet a day for 4 weeks | Dietary Supplement: Placebo tablet<br>* 1 tablet once daily for 4 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint | 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. | 56 days |