Lactobacillus Reuteri for the Treatment of Infantile Colic:

Infantile Colic Clinical Trial

— LRTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046617
• Other study ID #: 153/2009
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: June 4, 2012
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Crying
• Infantile Colic

Intervention

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

Locations

Country	Name	City	State
Poland	The Medical University of Warsaw, Outpatient Clinic	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of crying (minutes per day)		21 days	No
Primary	Reduction on the daily average crying time >50% during the study		21 days	No
Secondary	Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day		21 days	No
Secondary	Persistence of infantile colic after the intervention		21 days	No
Secondary	Parental perception of severity		21 days	No
Secondary	Parental or family quality of life		21 days	No
Secondary	Growth parameters		21 days	Yes
Secondary	Adverse effects (e.g. vomiting, constipation, etc.)		21 days	Yes