Status:
TERMINATED
Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
Lead Sponsor:
BioGaia AB
Collaborating Sponsors:
Sprim CRO, Italia
Conditions:
Abdominal Pain
Eligibility:
All Genders
8-14 years
Phase:
NA
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 (severit...
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 comple...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01498666
Start Date
December 1 2011
End Date
April 1 2013
Last Update
June 2 2021
Active Locations (2)
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1
AO Niguarda Ca' granda
Milan, Italy, 20162
2
AO "San Paolo"
Milan, Italy, 201442