Effects of Probiotic and Prebiotic Combinations on Premature Infants

• ClinicalTrials.gov Identifier: NCT00282113
• Recruitment Status: Completed
• First Posted: January 25, 2006
• Results First Posted: January 28, 2010
• Last Update Posted: January 28, 2010
• Sponsor: University of California, Davis
• Information provided by: University of California, Davis

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Premature Infants; Stool Bacterial Composition; Growth	Dietary Supplement: ProBioPlus; Dietary Supplement: Culturelle; Other: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants
• Study Start Date: October 2004
• Actual Primary Completion Date: August 2006
• Actual Study Completion Date: August 2007

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Weight Gain [ Time Frame: 5 weeks ]
   Weight at five weeks minus birth weight

Secondary Outcome Measures :

1. Stool Colonization With Bifidobacteria [ Time Frame: 4 weeks ]
   Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.
2. Stool Short Chain Butyric Acid Content [ Time Frame: 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: up to 7 Days (Child)
• Sexes Eligible for Study: All
• 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

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 of Results:

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. doi: 10.1097/MPG.0b013e31818de195.

• Responsible Party: Mark A. Underwood, UC Davis
• ClinicalTrials.gov Identifier: NCT00282113
• Other Study ID Numbers: 2004122333-1
• First Posted: January 25, 2006
• Results First Posted: January 28, 2010
• Last Update Posted: January 28, 2010
• Last Verified: December 2009

Keywords provided by University of California, Davis:

Probiotic; Prebiotic; NEC; Premature infants; commensal flora

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications