Effects of Probiotic and Prebiotic Combinations on Premature Infants

Growth Clinical Trial

Official title:

Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282113
• Other study ID #: 2004122333-1
• Status: Completed
• Phase: N/A
• First received: January 23, 2006
• Last updated: December 31, 2009
• Start date: October 2004
• Est. completion date: August 2007

Study information

• Verified date: December 2009
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Growth
• Premature Birth
• Premature Infants
• Stool Bacterial Composition

Intervention

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.
• Culturelle
Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.

Other:
• Placebo
A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain		5 weeks	No
Secondary	Stool Colonization With Bifidobacteria		4 weeks	No
Secondary	Stool Short Chain Butyric Acid Content		4 weeks	No