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

BioGaia

Status

Terminated

Conditions

Abdominal Pain

Treatments

Dietary Supplement: Placebo tablet

Dietary Supplement: L. reuteri protectis

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01498666

Q-PRE-0111-CLI-018

Details and patient eligibility

About

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).

Full 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.

Enrollment

9 patients

Sex

All

Ages

8 to 14 years old

Volunteers

No Healthy Volunteers

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