Lactobacillus Reuteri for the Treatment of Infantile Colic:
Condition: Infantile Colic; Crying
MeSH terms: Colic
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Lactobacillus reuteri (DSM 17938)
Intervention type(s): Dietary Supplement
Intervention description(s): 5 drops once daily (10(8) CFU) for 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infantile colic; Lactobacillus reuteri; duration of crying