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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046617
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : June 5, 2012
Information provided by:
Medical University of Warsaw

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Dietary Supplement: Lactobacillus reuteri (DSM 17938)
    5 drops once daily (10(8) CFU) for 21 days

Primary Outcome Measures :
  1. Duration of crying (minutes per day) [ Time Frame: 21 days ]
  2. Reduction on the daily average crying time >50% during the study [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day [ Time Frame: 21 days ]
  2. Persistence of infantile colic after the intervention [ Time Frame: 21 days ]
  3. Parental perception of severity [ Time Frame: 21 days ]
  4. Parental or family quality of life [ Time Frame: 21 days ]
  5. Growth parameters [ Time Frame: 21 days ]
  6. Adverse effects (e.g. vomiting, constipation, etc.) [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046617

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hania Szajewska, Department of Paediatrics, The Medical University of Warsaw Identifier: NCT01046617     History of Changes
Other Study ID Numbers: 153/2009
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Infant, Newborn, Diseases