Effect of Probiotics in Childhood Abdominal Pain

The Effect of Probiotics in Childhood Abdominal Pain

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180556

Enrollment

101

Registered

2010-08-12

Start date

2011-03-31

Completion date

2013-10-31

Last updated

2016-03-29

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

Conditions

Abdominal Pain

Keywords

childhood, abdominal pain, probiotics

Brief summary

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.

Detailed description

Prospective randomized double-blind placebo-controlled trial.

Interventions

DIETARY_SUPPLEMENTProbiotics

Daily oral supplementation for four weeks

DIETARY_SUPPLEMENTPlacebo

Placebo administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

Inclusion criteria

* Healthy children

Exclusion criteria

* Any chronic or organic illness

Design outcomes

Primary

Measure	Time frame	Description
Frequency and intensity of abdominal pain	Eight weeks	Number of pain episodes and pain intensity based on a visual scale

Secondary

Measure	Time frame	Description
School absenteeism	Eight weeks	Number of patients with school absenteeism
Other gastrointestinal symptoms	Eight weeks	Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating
Adverse effects related to treatment	Eight weeks	Any adverse effects related to the probiotic supplementation

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026