NCT01017991

Brief Summary

The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

November 20, 2009

Last Update Submit

November 13, 2017

Conditions

Crying

Keywords

infantsformulaprobioticcrying

Outcome Measures

Primary Outcomes (1)

  • daily total crying time

    28 days

Secondary Outcomes (2)

  • Formula intake

    4 days

  • Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies

    4 days

Study Arms (2)

Infant formula with probiotic

EXPERIMENTAL

Infant formula with probiotic for 0 to 12 months of age

Other: Milk based infant formula with probiotic

Standard infant formula

PLACEBO COMPARATOR

Infant formula for 0 to 12 months of age

Other: Milk based infant formula

Interventions

Milk based infant formula with probioticOTHER

formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration

Infant formula with probiotic
Milk based infant formulaOTHER

supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days

Standard infant formula

Eligibility Criteria

Age3 Weeks - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • full term infants greater than or equal to 37 wks gestation
  • weeks to less than or equal to 4 months of age upon enrollment
  • experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
  • otherwise healthy as reported by parent/caregiver
  • is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
  • taking no more than one feeding of breast milk per day
  • having not initiated weaning foods or beverages other than infant formula or breast milk
  • study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
  • informed consent signed(parent/legal representative)

You may not qualify if:

  • Chromosomal or major congenital anomalies
  • known cow's milk allergy
  • receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
  • receiving an antibiotic or probiotic in the week prior to enrollment
  • complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
  • infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
  • infant currently participating in another conflicting clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Children's Investigational Research Program, LLC

Bentonville, Arkansas, 72712, United States

Location

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 2007, United States

Location

Florida Institute for Clinical Research

Orlando, Florida, 32822, United States

Location

Pedia Research, LLC

Newburgh, Indiana, 47630, United States

Location

Pedia Research

Owensboro, Kentucky, 42301, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Southwest Children's Research Associates, P.A.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Crying

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Michael D Cabana, MD,MPH

    University of California, San Francisco, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2012

Study Completion

March 1, 2013

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(9)