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CompletedNCT01180556Updated Mar 29, 2016

Effect of Probiotics in Childhood Abdominal Pain

An interventional study of Probiotics and Placebo in Abdominal Pain, sponsored by Soroka University Medical Center. Completed at 1 site in Israel. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
6 Years to 15 Years
Sex
All
01

Study 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.

Read the detailed description

Prospective randomized double-blind placebo-controlled trial.

02

Conditions studied

  • Abdominal Pain

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Keywords

  • childhood
  • abdominal pain
  • probiotics
03

In context

Abdominal Pain

344 studies on the registry are indexed under Abdominal Pain; 53 are open to participants now.

This study's enrollment of 101 is above the median of 70 across 256 interventional studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

Soroka University Medical Center is the lead sponsor of 159 studies on the registry; 2 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy children

Exclusion criteria

Exclusion Criteria:

  • Any chronic or organic illness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Probiotics supplementation

    Supplementation by probiotics for 4 weeks

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Supplementation of placebo for 4 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotics

    Daily oral supplementation for four weeks

    Also known as: probiotic agent, L. reuteri

  • Dietary supplementPlacebo

    Placebo administration

    Also known as: placebo tablets

06

What researchers measure

Primary outcomes

  1. Frequency and intensity of abdominal pain

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

    Time frame: Eight weeks

Secondary outcomes

  1. School absenteeism

    Number of patients with school absenteeism

    Time frame: Eight weeks

  2. Other gastrointestinal symptoms

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

    Time frame: Eight weeks

  3. Adverse effects related to treatment

    Any adverse effects related to the probiotic supplementation

    Time frame: Eight weeks

07

Study locations

1 site
  • Soroka Medical Center
    Beersheba, 84101, Israel
08

References and documents

Publications

  • 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. PubMed 27156182 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2010
First posted
Aug 12, 2010
Start
Mar 2011
Primary completionActual
Oct 2013
CompletionActual
Oct 2013
Last update
Mar 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01180556
Lead sponsor
Soroka University Medical Center
Responsible party
Sponsor
First posted
Aug 12, 2010
Start date
Mar 2011
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Mar 29, 2016

Study contacts

Zvi Weizman, MD
principal investigator · Soroka University Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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