search
Back to results

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic (LGG)

Primary Purpose

Colic, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutramigen with Enflora
Nutramigen A+
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colic focused on measuring Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary, Breath Hydrogen, Clinical Design

Eligibility Criteria

3 Weeks - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nutramigen Lipil with Enflora

Nutramigen A+

Arm Description

Formula with probiotics (Lactobaccillus Rhamnosus GG)

Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fecal Microbiota
Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.
Fecal Calprotectin
Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.

Full Information

First Posted
January 12, 2011
Last Updated
October 7, 2015
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Mead Johnson Nutrition
search

1. Study Identification

Unique Protocol Identification Number
NCT01279265
Brief Title
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Acronym
LGG
Official Title
Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Mead Johnson Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic, Inflammation
Keywords
Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary, Breath Hydrogen, Clinical Design

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutramigen Lipil with Enflora
Arm Type
Active Comparator
Arm Description
Formula with probiotics (Lactobaccillus Rhamnosus GG)
Arm Title
Nutramigen A+
Arm Type
Placebo Comparator
Arm Description
Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutramigen with Enflora
Intervention Description
Hypoallergenic formula with probiotic - Lactobacillus GG
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutramigen A+
Other Intervention Name(s)
(Nutramigen Lipil)
Intervention Description
Hypoallergenic formula without lactobacillus
Primary Outcome Measure Information:
Title
Daily Average Crying and Fussing Duration According to Barr Diary Records
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Fecal Microbiota
Description
Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.
Time Frame
90 days
Title
Fecal Calprotectin
Description
Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks) Exclusion Criteria: chronic lung disease, diarrhea (stools that take the shape of a container > 5x daily) fever
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. M Rhoads, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19628216
Citation
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.
Results Reference
background
PubMed Identifier
30177353
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

We'll reach out to this number within 24 hrs