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Lactobacillus Reuteri for the Treatment of Infantile Colic:

NCT01046617 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-06-05

No results posted yet for this study

Summary

Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as \>3 hours of crying on \>3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported.

Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.

Conditions

  • Infantile Colic
  • Crying

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri (DSM 17938)

5 drops once daily (10(8) CFU) for 21 days

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01046617 on ClinicalTrials.gov