NCT01067027

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

February 9, 2010

Last Update Submit

June 28, 2011

Conditions

Colic

Keywords

ColicColic in Breast-fed Infants

Outcome Measures

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.

    7, 14 and 21 days

Secondary Outcomes (1)

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

    21 days

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

5 drops of study product 30 minutes before feeding.

Eligibility Criteria

Age14 Days - 60 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Major chronic disease
  • Administration of anitbiotics the week before randomization
  • Administration of probiotics the week before randomization
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Investigational Research Program

Bentonville, Arkansas, 72712, United States

RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bryan M Harvey, M.D.

    Children's Investigational Research Program

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Misty R Ross, MA

CONTACT

479-254-6772mross@chirpresearch.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

US(1)