Lactobacillus Reuteri for the Treatment of Infantile Colic: (LRTIC)
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|ClinicalTrials.gov Identifier: NCT01046617|
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : June 5, 2012
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lactobacillus Reuteri (DSM 17938) for the Treatment of Infantile Colic: a Randomized Double-blind Placebo Controlled Trial|
|Study Start Date :||December 2009|
|Primary Completion Date :||April 2012|
|Study Completion Date :||April 2012|
Dietary Supplement: Lactobacillus reuteri (DSM 17938)
- Duration of crying (minutes per day) [ Time Frame: 21 days ]
- Reduction on the daily average crying time >50% during the study [ Time Frame: 21 days ]
- Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day [ Time Frame: 21 days ]
- Persistence of infantile colic after the intervention [ Time Frame: 21 days ]
- Parental perception of severity [ Time Frame: 21 days ]
- Parental or family quality of life [ Time Frame: 21 days ]
- Growth parameters [ Time Frame: 21 days ]
- Adverse effects (e.g. vomiting, constipation, etc.) [ Time Frame: 21 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT01046617
|The Medical University of Warsaw, Outpatient Clinic|
|Warsaw, Poland, 01-184|