NCT01541046

Brief Summary

Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment. We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo. An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

February 23, 2012

Last Update Submit

November 19, 2014

Conditions

Colic

Keywords

pediatricinfantile colicprobiotic treatment

Outcome Measures

Primary Outcomes (1)

  • Mean change in crying time

    Reduction of daily median crying time (measured with parental diary) with L. reuteri DSM 17938 versus placebo at any of the time points 7, 14, and 21 days

    Baseline, 7 days, 14 days, 21 days

Secondary Outcomes (5)

  • Number of responders vs. non-responders

    Baseline, at 7, 14 and 21 days

  • Parental quality of life

    Daily for 21 days

  • Number of episodes of crying

    Over 21 days

  • Duration of episodes of crying

    Over 21 days

  • Changes in stool consistency

    Over 21 days

Study Arms (2)

Biogaia L. reuteri DSM 17938

EXPERIMENTAL

Biogaia L. reuteri DSM 17938, probiotic infant drops (5 drops=10\^8 cfu),5 drops, once per day for 21 days.

Biological: Biogaia L. reuteri DSM 17938

Probiotic Placebo

PLACEBO COMPARATOR

Placebo drops (sunflower oil, medium chain triglyceride oil, silicon chloride), 5 drops, once a day for 21 days.

Biological: Probiotic Placebo

Interventions

Biogaia L. reuteri DSM 17938BIOLOGICAL

Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™

Biogaia L. reuteri DSM 17938
Probiotic PlaceboBIOLOGICAL

Description of Placebo: contains same excipients as Active Agent, without the active ingredient

Probiotic Placebo

Eligibility Criteria

Age21 Days - 180 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term infant 21-90 days of age
  • Birth weight ≥2500 g
  • Exclusively breastfed (to reduce variability in the intestinal microflora attributable to dietary variations)
  • With colic symptoms (\>3 hours of crying on \>3 days per week) with debut 10 ± 5 days before enrollment
  • Gestational age between 37 and 42 weeks
  • Apgar score higher than 7 at 5 minutes
  • Written informed consent from a parent

You may not qualify if:

  • Any chronic illness or gastrointestinal disorder as judged by the pediatrician
  • Any history of antibiotic treatment or probiotic supplementation
  • Failure to obtain a written consent by parent/legal guardian
  • Participation in other clinical trials
  • Infants with acute illness
  • Subjects with allergies or family history of allergies to any of the ingredients of the study product or placebo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Related Publications (1)

  • Chau K, Lau E, Greenberg S, Jacobson S, Yazdani-Brojeni P, Verma N, Koren G. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. J Pediatr. 2015 Jan;166(1):74-8. doi: 10.1016/j.jpeds.2014.09.020. Epub 2014 Oct 23.

    PMID: 25444531DERIVED

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gideon Koren, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

November 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

CA(1)