Effectiveness of probiotics in the treatment of children with chronic abdominal pain and small intestinal bacterial overgrowth. A randomized placebo-controlled trial.

Completed

Conditions: chronic abdominal pain
small intestinal bacterial overgrowth
10018012

Registration Number: NL-OMON39168

Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

Children with abdominal pain as result of inflammatory, anatomic, metabolic or neoplastic disease. Children who were prescribed antibiotics or probiotics in the last month. Children who are critically ill or admitted at the ICU. Children who receive feeding via a tube.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures are the percentages of patients with complete<br /><br>remission of chronic abdominal pain after the treatment phase<br /><br>(t = 1), at six months follow up (t = 2) and 12 month after starting the<br /><br>therapy (t=3). Clinical remission is defined as a decrease of the pain<br /><br>intensity score and pain frequency score of > 80%; significant improvement is<br /><br>defined as a decrease of pain intensity score and pain frequency score between<br /><br>30% and 80% and treatment is considered unsuccessful if the scores improved <<br /><br>30% or got worse. </p><br>

Secondary Outcome Measures