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