Effects of Probiotic and Prebiotic Combinations on Premature Infants - Full Text View

Purpose

The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. Our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.

Condition	Intervention
Premature Infants Stool Bacterial Composition Growth	Dietary Supplement: ProBioPlus Dietary Supplement: Culturelle Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Premature Babies

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Weight Gain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stool Colonization With Bifidobacteria [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Stool Short Chain Butyric Acid Content [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	October 2004
Study Completion Date:	August 2007
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ProBioPlus	Dietary Supplement: ProBioPlus ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily.
Active Comparator: Culturelle	Dietary Supplement: Culturelle Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.
Placebo Comparator: Placebo	Other: Placebo A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products

Detailed Description:

Premature infants are at risk for a devastating infection of the intestines due to the immaturity of their intestines and immune system. Probiotics are bacteria with healthful qualities that are taken by mouth to improve the number of healthy bacteria in the intestines. Probiotics have been shown in several studies outside the U.S. to decrease the risk of serious intestinal infection and in one small study to improve the rate of weight gain in premature infants. Prebiotics are food supplements that stimulate the growth of healthy bacteria and suppress the growth of unhealthy bacteria. Prebiotics have been shown to improve the numbers of healthy bacteria in the stool of premature babies. Our study is designed to compare two over the counter probiotic/prebiotic combinations to each other and to a control group. Infants less than 35 weeks with a birthweight of 750-2000 gm are eligible and must be enrolled in the study within the first week of life. The babies are randomly assigned to either a control group (no probiotic/prebiotic, just a placebo), a group which receives Culturelle (Lactobacillus rhamnosus GG plus fructo-oligosaccharide, ConAgra), or a group which receives ProBioPlus (three strains of Bifidobacteria plus Lactobacillus acidophilus plus fructo-oligosaccharide, UAS Laboratories). The babies receive the study product by mouth twice daily for 28 days or until discharge (whichever comes first). Weekly measurements (weight, length, head size) and stool cultures are performed. Clinical progress is closely monitored and any episodes of infection are recorded.

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

less than 35 weeks gestation, birth weight 750-2000 grams
born in or transferred to University of California Davis Medical Center within first week of life
less than eight days of age at the time of enrollment

Exclusion Criteria:

Severe intestinal or cardiac congenital anomalies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282113

Locations

United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Michael P Sherman, MD

University of California, Davis

More Information

Publications:

Underwood MA, Salzman NH, Bennett SH, Barman M, Mills DA, Marcobal A, Tancredi DJ, Bevins CL, Sherman MP. A randomized placebo-controlled comparison of 2 prebiotic/probiotic combinations in preterm infants: impact on weight gain, intestinal microbiota, and fecal short-chain fatty acids. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):216-25.

Responsible Party:	Mark A. Underwood, UC Davis
ClinicalTrials.gov Identifier:	NCT00282113 History of Changes
Other Study ID Numbers:	2004122333-1
Study First Received:	January 23, 2006
Results First Received:	November 19, 2009
Last Updated:	December 31, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Probiotic
Prebiotic
NEC
Premature infants
commensal flora

ClinicalTrials.gov processed this record on June 18, 2013