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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01279265
Recruitment Status : Completed
First Posted : January 19, 2011
Results First Posted : November 11, 2015
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Colic
Inflammation
Interventions Dietary Supplement: Nutramigen with Enflora
Dietary Supplement: Nutramigen A+
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+
Hide Arm/Group Description Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without lactobacilli

Nutramigen A+: Hypoallergenic formula without lactobacillus

Period Title: Overall Study
Started 13 17
Completed 9 11
Not Completed 4 6
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+ Total
Hide Arm/Group Description Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without lactobacilli

Nutramigen A+: Hypoallergenic formula without lactobacillus

Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
9
 100.0%
11
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
4
  44.4%
4
  36.4%
8
  40.0%
Male
5
  55.6%
7
  63.6%
12
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  33.3%
4
  36.4%
7
  35.0%
White
6
  66.7%
7
  63.6%
13
  65.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
1.Primary Outcome
Title Daily Average Crying and Fussing Duration According to Barr Diary Records
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+
Hide Arm/Group Description:
Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without lactobacilli

Nutramigen A+: Hypoallergenic formula without lactobacillus

Overall Number of Participants Analyzed 9 11
Mean (95% Confidence Interval)
Unit of Measure: minutes
111
(65 to 157)
133
(60 to 205)
2.Secondary Outcome
Title Fecal Microbiota
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+
Hide Arm/Group Description:
Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without lactobacilli

Nutramigen A+: Hypoallergenic formula without lactobacillus

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: Shannon's diversity index value
Visit 1 - Baseline .946  (.927) .991  (.415)
Visit 2- Day 14 1.314  (.789) .537  (.289)
Visit 3 - Day 42 1.047  (.350) 1.161  (.612)
Visit 4 - Day 90 .676  (.444) .737  (.409)
3.Secondary Outcome
Title Fecal Calprotectin
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+
Hide Arm/Group Description:

Formula with probiotics (Lactobaccillus Rhamnosus GG)

Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Nutramigen A+: Hypoallergenic formula without lactobacillus

Overall Number of Participants Analyzed 9 11
Mean (95% Confidence Interval)
Unit of Measure: µg/g (feces)
Visit 1- Baseline
285
(199 to 371)
294
(184 to 404)
Visit 2 - Day 14
226
(182 to 270)
305
(186 to 423)
Visit 3 - Day 42
229
(113 to 345)
250
(154 to 347)
Visit 4 - Day 90
211
(80 to 342)
332
(225 to 440)
Time Frame 90 days (3 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nutramigen Lipil With Enflora Nutramigen A+
Hide Arm/Group Description Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG

Hypoallergenic formula without lactobacilli

Nutramigen A+: Hypoallergenic formula without lactobacillus

All-Cause Mortality
Nutramigen Lipil With Enflora Nutramigen A+
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nutramigen Lipil With Enflora Nutramigen A+
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nutramigen Lipil With Enflora Nutramigen A+
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
75% of eligible babies either declined to enter the study or dropped out.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. J. Marc Rhoads, Director, Pediatric Gastroenterology
Organization: University of Texas Health Science Center at Houston
Phone: 713-500-7642
EMail: j.marc.rhoads@uth.tmc.edu
Layout table for additonal information
Responsible Party: J. Marc Rhoads, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01279265    
Other Study ID Numbers: HSC-MS-10-0048
First Submitted: January 12, 2011
First Posted: January 19, 2011
Results First Submitted: June 11, 2015
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015