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NCT Number: NCT01279265

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

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.

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Key information

Conditions

Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 week–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutramigen with Enflora

Dietary Supplement

Hypoallergenic formula with probiotic - Lactobacillus GG

Nutramigen A+

Dietary Supplement

Hypoallergenic formula without lactobacillus

Other names: (Nutramigen Lipil)

Primary outcomes

  1. Daily Average Crying and Fussing Duration According to Barr Diary Records

    Time frame: 90 days

    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 outcomes

  1. Fecal Microbiota

    Time frame: 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.

  2. Fecal Calprotectin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study title

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

Acronym: LGG

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 19, 2011
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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