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Status unknownNCT01067027Updated Jun 29, 2011

Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri

A Phase 4 interventional study of Lactobacillus reuteri in Colic, sponsored by Children's Investigational Research Program, LLC. Status unknown at 1 site in United States. Open to participants aged 14 Days to 60 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-29.

Sponsored by Children's Investigational Research Program, LLC · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
14 Days to 60 Days
Sex
All
01

Study summary

It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.

02

Conditions studied

  • Colic

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Keywords

  • Colic
  • Colic in Breast-fed Infants
03

In context

Colic

148 studies on the registry are indexed under Colic; 21 are open to participants now.

This study's planned enrollment of 50 is below the median of 88 across 122 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

This is the only study on the registry with Children's Investigational Research Program, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Days to 60 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ifants aged between 14 and 60 days
  • Breast fed, exclusively during length of trial
  • Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
  • Debut of colic symptoms 6+/-1 days before randomization
  • Gestational age between 37 and 42 weeks
  • Apgar score higher than 7 at 5 minutes
  • Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
  • Written informed consent from one or both parents
  • Stated availability throughout the study period

Exclusion criteria

Exclusion Criteria:

  • Major chronic disease
  • Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
  • Administration of anitbiotics the week before randomization
  • Administration of probiotics the week before randomization
  • Participation in other clinical trials
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Interventions

  • Dietary supplementLactobacillus reuteri

    5 drops of study product 30 minutes before feeding.

06

What researchers measure

Primary outcomes

  1. * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.

    Time frame: 7, 14 and 21 days

Secondary outcomes

  1. Number of responders versus non-responders with L. reuteri versus placebo at end of the study.

    Time frame: 21 days

07

Study locations

1 of 1 sites recruiting
  • Children's Investigational Research Program
    Bentonville, Arkansas 72712, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01067027
Lead sponsor
Children's Investigational Research Program, LLC
First posted
Feb 11, 2010
Start date
Jun 2009
Primary completion
Dec 2011 (estimated)
Completion
Jun 2012 (estimated)
Last update
Jun 29, 2011

Study contacts

Misty R Ross, MA
Contact
mross@chirpresearch.com
479-254-6772 ext. 21
Bryan M Harvey, M.D.
principal investigator · Children's Investigational Research Program

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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