NCT01279265

Brief Summary

This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

January 12, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 11, 2015

Completed
Last Updated

November 11, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

January 12, 2011

Results QC Date

June 11, 2015

Last Update Submit

October 7, 2015

Conditions

ColicInflammation

Keywords

LactobacillusProbioticCrying timeFecal microbiotaCalprotectinColicInfant CryingBarr DiaryBreath HydrogenClinical Design

Outcome Measures

Primary Outcomes (1)

  • Daily Average Crying and Fussing Duration According to Barr Diary Records

    The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.

    90 days

Secondary Outcomes (2)

  • Fecal Microbiota

    90 days

  • Fecal Calprotectin

    90 days

Study Arms (2)

Nutramigen Lipil with Enflora

ACTIVE COMPARATOR

Formula with probiotics (Lactobaccillus Rhamnosus GG)

Dietary Supplement: Nutramigen with Enflora

Nutramigen A+

PLACEBO COMPARATOR

Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Dietary Supplement: Nutramigen A+

Interventions

Nutramigen with EnfloraDIETARY_SUPPLEMENT

Hypoallergenic formula with probiotic - Lactobacillus GG

Nutramigen Lipil with Enflora
Nutramigen A+DIETARY_SUPPLEMENT

Hypoallergenic formula without lactobacillus

Also known as: (Nutramigen Lipil)
Nutramigen A+

Eligibility Criteria

Age3 Weeks - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

You may not qualify if:

  • chronic lung disease,
  • diarrhea (stools that take the shape of a container \> 5x daily)
  • fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22.

    PMID: 19628216BACKGROUND

  • Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.

    PMID: 30177353DERIVED

MeSH Terms

Conditions

ColicInflammation

Interventions

pregestimil

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

75% of eligible babies either declined to enter the study or dropped out.

Results Point of Contact

Title
Dr. J. Marc Rhoads, Director, Pediatric Gastroenterology
Organization
University of Texas Health Science Center at Houston
j.marc.rhoads@uth.tmc.edu
713-500-7642

Study Officials

  • J. M Rhoads, M.D.

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Pediatrics, Gastroenterology

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 19, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 11, 2015

Results First Posted

November 11, 2015

Record last verified: 2015-10

Locations

US(1)