Effectiveness of probiotics of children with chronic abdominal pain en bacterial overgrowth.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20319

Enrollment

Registered

2012-02-14

Start date

2012-03-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic abdominal pain, small intestinal bacterial overgrowth

Interventions

The probiotics consist of a mixture of Bifidobacterium and Lactobacillus (8 grams of powder 4 x 10E9 cfu Bifidobacterium and Lactobacillus (Ecologic junior)). This has te be used once a day for 8 week

Eligibility

Inclusion criteria

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

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; 3. Children who are critically ill or admitted at the ICU. Children who receive feeding via a tube.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary outcome measures is the presence of small intestinal bacterial overgrowth.	—

Contacts

Public ContactJ.J. Korterink

Postbus 90153

j.korterink@jbz.nl+31 (0)73 5337932

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)