COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effects of Probiotic and Prebiotic Combinations on Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00282113
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : January 28, 2010
Last Update Posted : January 28, 2010
Information provided by:
University of California, Davis

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.

Layout table for study information
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

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

Primary Outcome Measures :
  1. Weight Gain [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Stool Colonization With Bifidobacteria [ Time Frame: 4 weeks ]
  2. Stool Short Chain Butyric Acid Content [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00282113

Layout table for location information
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Layout table for investigator information
Principal Investigator: Michael P Sherman, MD University of California, Davis
Publications of Results:
Layout table for additonal information
Responsible Party: Mark A. Underwood, UC Davis Identifier: NCT00282113    
Other Study ID Numbers: 2004122333-1
First Posted: January 25, 2006    Key Record Dates
Results First Posted: January 28, 2010
Last Update Posted: January 28, 2010
Last Verified: December 2009
Keywords provided by University of California, Davis:
Premature infants
commensal flora
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications