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Completed

NCT Number: NCT01180556

Effect of Probiotics in Childhood Abdominal Pain

The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.

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Key information

Conditions

Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center

Beersheba, 84101, Israel

About this study

Prospective randomized double-blind placebo-controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children

Exclusion criteria

  • Any chronic or organic illness

Treatment and study plan

Probiotics

Dietary Supplement

Daily oral supplementation for four weeks

Other names: probiotic agent, L. reuteri

Placebo

Dietary Supplement

Placebo administration

Other names: placebo tablets

Primary outcomes

  1. Frequency and intensity of abdominal pain

    Time frame: Eight weeks

    Number of pain episodes and pain intensity based on a visual scale

Secondary outcomes

  1. School absenteeism

    Time frame: Eight weeks

    Number of patients with school absenteeism

  2. Other gastrointestinal symptoms

    Time frame: Eight weeks

    Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating

  3. Adverse effects related to treatment

    Time frame: Eight weeks

    Any adverse effects related to the probiotic supplementation

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

The Effect of Probiotics in Childhood Abdominal Pain

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2010
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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