NCT01180556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

August 9, 2010

Last Update Submit

March 27, 2016

Conditions

Abdominal Pain

Keywords

childhoodabdominal painprobiotics

Outcome Measures

Primary Outcomes (1)

  • Frequency and intensity of abdominal pain

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

    Eight weeks

Secondary Outcomes (3)

  • School absenteeism

    Eight weeks

  • Other gastrointestinal symptoms

    Eight weeks

  • Adverse effects related to treatment

    Eight weeks

Study Arms (2)

Probiotics supplementation

EXPERIMENTAL

Supplementation by probiotics for 4 weeks

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Supplementation of placebo for 4 weeks

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

Daily oral supplementation for four weeks

Also known as: probiotic agent, L. reuteri
Probiotics supplementation
PlaceboDIETARY_SUPPLEMENT

Placebo administration

Also known as: placebo tablets
Placebo

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children

You may not qualify if:

  • Any chronic or organic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Related Publications (1)

  • Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.

    PMID: 27156182DERIVED

MeSH Terms

Conditions

Abdominal Pain

Interventions

Probiotics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Zvi Weizman, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 12, 2010

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

IL(1)