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Completed

NCT Number: NCT01046617

Lactobacillus Reuteri for the Treatment of Infantile Colic:

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.

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Key information

Age range

1 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Medical University of Warsaw, Outpatient Clinic

Warsaw, 01-184, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri (DSM 17938)

Dietary Supplement

5 drops once daily (10(8) CFU) for 21 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Lactobacillus Reuteri (DSM 17938) for the Treatment of Infantile Colic: a Randomized Double-blind Placebo Controlled Trial

Acronym: LRTIC

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2010
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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