Trial Outcomes & Findings for Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic (NCT NCT01279265)

Last Updated: 2015-11-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

90 days

Results posted on

2015-11-11

Participant Flow

Participant milestones

Participant milestones
Measure	Nutramigen Lipil With Enflora Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG	Nutramigen A+ Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus
Overall Study STARTED	13	17
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nutramigen Lipil With Enflora n=9 Participants Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG	Nutramigen A+ n=11 Participants Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Nutramigen Lipil With Enflora n=9 Participants Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG	Nutramigen A+ n=11 Participants Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus
Daily Average Crying and Fussing Duration According to Barr Diary Records	111 minutes Interval 65.0 to 157.0	133 minutes Interval 60.0 to 205.0

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Outcome measures
Measure	Nutramigen Lipil With Enflora n=9 Participants Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG	Nutramigen A+ n=11 Participants Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus
Fecal Microbiota Visit 1 - Baseline	.946 Shannon's diversity index value Standard Deviation .927	.991 Shannon's diversity index value Standard Deviation .415
Fecal Microbiota Visit 2- Day 14	1.314 Shannon's diversity index value Standard Deviation .789	.537 Shannon's diversity index value Standard Deviation .289
Fecal Microbiota Visit 3 - Day 42	1.047 Shannon's diversity index value Standard Deviation .350	1.161 Shannon's diversity index value Standard Deviation .612
Fecal Microbiota Visit 4 - Day 90	.676 Shannon's diversity index value Standard Deviation .444	.737 Shannon's diversity index value Standard Deviation .409

SECONDARY outcome

Timeframe: 90 days

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.

Outcome measures

Outcome measures
Measure	Nutramigen Lipil With Enflora n=9 Participants Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG	Nutramigen A+ n=11 Participants Hypoallergenic formula without lactobacilli Nutramigen A+: Hypoallergenic formula without lactobacillus
Fecal Calprotectin Visit 1- Baseline	285 µg/g (feces) Interval 199.0 to 371.0	294 µg/g (feces) Interval 184.0 to 404.0
Fecal Calprotectin Visit 2 - Day 14	226 µg/g (feces) Interval 182.0 to 270.0	305 µg/g (feces) Interval 186.0 to 423.0
Fecal Calprotectin Visit 3 - Day 42	229 µg/g (feces) Interval 113.0 to 345.0	250 µg/g (feces) Interval 154.0 to 347.0
Fecal Calprotectin Visit 4 - Day 90	211 µg/g (feces) Interval 80.0 to 342.0	332 µg/g (feces) Interval 225.0 to 440.0

Adverse Events

Nutramigen Lipil With Enflora

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nutramigen A+

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. J. Marc Rhoads, Director, Pediatric Gastroenterology

University of Texas Health Science Center at Houston

Phone: 713-500-7642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place