Effectiveness of probiotics of children with chronic abdominal pain en bacterial overgrowth.
Suspended
- Conditions
- chronic abdominal pain, small intestinal bacterial overgrowth
- Registration Number
- NL-OMON20319
- Lead Sponsor
- Jeroen Bosch hospital, Den Bosch
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Children aged 8-18 years are included if they meet the criteria for functional dyspepsia, IBS, functional abdominal pain (FAP) or abdominal migraine, based on the Rome III Criteria for Functional Bowel Disorders Associated with Abdominal Pain or Discomfort in Children and have small intestinal bacterial overgrowth, diagnosed on hydrogen breath test as a fasting breath hydrogen concentration > 20 ppm or an increase of H2 levels of > 12 p.p.m. over the baseline value after ingestion of glucose.
Exclusion Criteria
1. Children with abdominal pain as result of inflammatory, anatomic, metabolic or neoplastic disease;
2. Children who were prescribed antibiotics or probiotics in the last month;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The reduction of abdominale pain is our primairy outcome. Abdominale pain is measured by an abdominal pain diary. Patients will be instructed to score pain intensity and pain frequency during 1 month at baseline period, after finishing the treatment and at 6 and 12 months follow up. Clinical remission is defined as a decrease of the pain intensity score and pain frequency score of > 80%; significant improvement is defined as a decrease of pain intensity score and pain frequency score between 30% and 80% and treatment is considered unsuccessful if the scores improved < 30% or got worse.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures is the presence of small intestinal bacterial overgrowth.