Lactobacillus Reuteri for the Treatment of Infantile Colic: (LRTIC)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01046617
First received: January 11, 2010
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Infantile Colic
Crying
Dietary Supplement: Lactobacillus reuteri (DSM 17938)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lactobacillus Reuteri (DSM 17938) for the Treatment of Infantile Colic: a Randomized Double-blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Duration of crying (minutes per day) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Reduction on the daily average crying time >50% during the study [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Persistence of infantile colic after the intervention [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Parental perception of severity [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Parental or family quality of life [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Growth parameters [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Adverse effects (e.g. vomiting, constipation, etc.) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Lactobacillus reuteri (DSM 17938)
    5 drops once daily (10(8) CFU) for 21 days
Detailed Description:

Eligible infants will be randomly assigned to receive either L. reuteri 108 CFU per day or placebo. Both the active treatment and placebo will be taken orally, 1 times daily, for 21 days.

All infants are eligible for screening. If a patient appears to meet the criteria for enrollment and express interest in the study, cow's milk elimination diet will be prescribed for 1 week to a breastfeeding mother (and to an infant, in case of formula fed infants). Care givers will be asked to record for 1 week symptoms of colic. Children fulfilling inclusion criteria will be asked to participate in the study.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Acute or chronic illness
  • Gastrointestinal disorders
  • Use of any antibiotics and/or probiotic pharmaceutical products within 7 days prior to the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046617

Locations
Poland
The Medical University of Warsaw, Outpatient Clinic
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
  More Information

No publications provided by Medical University of Warsaw

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hania Szajewska, Department of Paediatrics, The Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01046617     History of Changes
Other Study ID Numbers: 153/2009
Study First Received: January 11, 2010
Last Updated: June 4, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
infantile colic
Lactobacillus reuteri
duration of crying

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 29, 2014