- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046617
Lactobacillus Reuteri for the Treatment of Infantile Colic: (LRTIC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Warsaw, Poland, 01-184
- The Medical University of Warsaw, Outpatient Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of crying (minutes per day)
Time Frame: 21 days
|
21 days
|
Reduction on the daily average crying time >50% during the study
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of the daily average crying time, from baseline to the end of the treatment period, to <3 hours/day
Time Frame: 21 days
|
21 days
|
Persistence of infantile colic after the intervention
Time Frame: 21 days
|
21 days
|
Parental perception of severity
Time Frame: 21 days
|
21 days
|
Parental or family quality of life
Time Frame: 21 days
|
21 days
|
Growth parameters
Time Frame: 21 days
|
21 days
|
Adverse effects (e.g. vomiting, constipation, etc.)
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infantile Colic
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SOFAR S.p.A.CompletedInfantile Colic | Colic, InfantileItaly
-
Federico II UniversityCompleted
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University of NebraskaiHealthTerminatedInfantile ColicUnited States
-
Lallemand Health SolutionsProbiSearch SLWithdrawn
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BioGaia ABHopital Universitaire Robert-Debre; Association Clinique Thérapeutique Infantile... and other collaboratorsWithdrawnInfantile ColicFrance
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Nordic Institute of Chiropractic and Clinical BiomechanicsResearch Unit of General Practice, OdenseCompleted
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Nordic Institute of Chiropractic and Clinical BiomechanicsUniversity of Southern Denmark; Foundation for the Advancement of Chiropractic...TerminatedInfantile ColicDenmark
-
Menarini GroupWithdrawn
Clinical Trials on Lactobacillus reuteri (DSM 17938)
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Medical University of WarsawCompletedGastroenteritis | Diarrhea | Nosocomial InfectionPoland
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Vastra Gotaland RegionCompletedInsulin Resistance | Type 2 DiabetesSweden
-
Örebro University, SwedenBioGaia ABCompletedAbdominal Pain | Constipation | Diarrhea | Reflux | IndigestionSweden
-
Szpital im. Św. Jadwigi ŚląskiejCompletedAcute GastroenteritisPoland
-
Hospital General Naval de Alta Especialidad - Escuela...Unknown
-
Children's Memorial Health Institute, PolandUnknown
-
Children's Hospital and Institute of Child Health...UnknownSepsis | Necrotizing Enterocolitis
-
Medical University of WarsawCompleted
-
Good Food Practice, SwedenBioGaia ABCompleted
-
University of CopenhagenCompleted