Abdominal Pain
Conditions
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.
Interventions
DIETARY_SUPPLEMENTL. reuteri protectis
1 tablet once daily for 4 weeks
DIETARY_SUPPLEMENTPlacebo tablet
1 tablet once daily for 4 weeks
Sponsors
Sprim CRO, Italia
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed