Lactobacillus Reuteri for the Treatment of Infantile Colic:

NCT01046617 | Completed Phase 3 DMC

• 1 other identifier: 153/2009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infantile colic; Lactobacillus reuteri; duration of crying

Outcome Measures

Primary Outcomes (2)

• Duration of crying (minutes per day)

  21 days

• Reduction on the daily average crying time >50% during the study

  21 days

Secondary Outcomes (6)

• Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day

  21 days

• Persistence of infantile colic after the intervention

  21 days

• Parental perception of severity

  21 days

• Parental or family quality of life

  21 days

• Growth parameters

  21 days

Interventions

Lactobacillus reuteri (DSM 17938) DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 1 Month - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full-term infants age \<5 months
• Infantile colic (\>3 hours of crying on \>3 days in the week) within 7 days prior to enrollment
• Exclusive or predominant (\>50%) breastfeeding
• Informed consent

You may not qualify if:

• Acute or chronic illness
• Gastrointestinal disorders
• Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

The Medical University of Warsaw, Outpatient Clinic

Warsaw, 01-184, Poland

Location

Related Publications (1)

• Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.

  PMID: 22981952 DERIVED

MeSH Terms

Conditions

Colic; Crying

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: December 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

PL (1)