Functional Abdominal Pain (FAP) in Children Clinical Trial
Official title:
Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children
The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP.
Status | Completed |
Enrollment | 54 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 16 Years |
Eligibility |
Inclusion Criteria: Subjects will be recruited according to the following inclusion criteria: - FAP (Functional Abdominal Pain) according to Rome III criteria for Child/Adolescent; 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 of 5-16 years; - Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale; - Pain frequency of at least 1 or more episodes per week over the preceding 8 weeks; - Ability to understand and comply with the requirements of the trial; - Stated availability throughout the study period Exclusion Criteria: Subjects presenting with one or more of the following criteria will be excluded from participation in the study: - Chronic illness; - Surgery of gastrointestinal tract - Any symptoms/signs of organic disease and/or any abnormal results of laboratory assays (total blood count, serum glucose, urea, electrolytes, amylase, SGOT, SGPT, anti tTG antibodies, breath H2 test, suggesting disease other than FAP; - Weight loss of 5% or more in body weight over the preceding 3 months; - Exposure to any drugs for FAP in the past 2 weeks. - 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 interventional clinical trials in the past 3 months; - Subjects with special dietary needs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Athens Children's Hospital "AGIA SOPHIA" | Athens | Attica |
Poland | University of Warsaw, Department of Pediatrics | Warsaw | |
Slovenia | University of Ljubljana, Children's Hospital, Department of Gastroenterology | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Aghia Sophia Children's Hospital of Athens | BioGaia AB |
Greece, Poland, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abdominal pain frequency and severity over the 4-week treatment period. | Reduction in pain frequency measured by a subject diary, in the L. reuteri DSM 17938 group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri DSM 17938 vs placebo over the treatment period. Reduction in pain severity is assessed using the face score system of Wong-Baker at day 14 and at the end of treatment (day 28)vs. baseline. Area under the pain-intensity curve will be assessed for Weeks 1-4 and Weeks 1-2 |
4 weeks | No |
Secondary | Reduction in pain frequency and intensity over the 8-week study period | Reduction in pain frequency measured by a subject diary in the L. reuteri group expressed as area under the L. reuteri pain-frequency curve compared to placebo over the initial 2 weeks of the treatment period as well as over the whole study period. Reduction in pain intensity, measured by the face score system of Wong-Baker at day 14, end of treatment (day 28), and end of follow-up period (day 56) vs baseline. Area under the pain-intensity curve for Weeks 1-4 and Weeks 1-2 will be compared. |
8 weeks | No |
Secondary | Reduction in other GI symptoms over the whole study period | Reduction in other GI symptoms as measured by Gastrointestinal Symptom Rating Scoring system. Time points: baseline, day 14, end of treatment and end of follow-up, in the L. reuteri group vs. placebo. | 8 weeks | No |
Secondary | Days of absence from school and other activities due to abdominal pain over the whole study period | The number of days of absence from school and other activities due to abdominal pain will be compared between the L. reuteri group vs placebo. | 8 weeks | No |
Secondary | Reduction in absence from work by parents over the whole study period | he number of days of absence from work by parents due to abdominal pain of the child will be compared between the L. reuteri group vs placebo. | 8 weeks | No |
Secondary | Safety outcome over the whole study period | The number of adverse events will be observed and recorded during the entire study period | 8 weeks | Yes |