The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2009 |
| End Date: | April 2015 |
| Contact: | Majid Mirmiran, MD, PhD |
| Email: | majid.mirmiran@ucdmc.ucdavis.edu |
| Phone: | 916-734-4790 |
Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
The purpose of this study is to see whether dietary supplements can change the germs in the
intestines of premature infants to be more like those of healthy breast fed term babies.
intestines of premature infants to be more like those of healthy breast fed term babies.
To determine the optimum dose and optimum dietary supplement to promote a fecal microflora
in the formula fed premature infant that is similar to that of the term breast fed infant (a
predominance of bifidobacteria). In the initial phase of this trial, 30 premature infants
will be randomly assigned to receive increasing doses of one of four dietary supplements:
Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides
processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods),
Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be
examined by PCR to determine content of bifidobacteria and total bacteria. This study is
limited to formula fed infants in order to avoid the confounding effects of the human milk
oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled
and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate
containing humna milk oligosaccharides) or powdered human milk fortifier for comparison
in the formula fed premature infant that is similar to that of the term breast fed infant (a
predominance of bifidobacteria). In the initial phase of this trial, 30 premature infants
will be randomly assigned to receive increasing doses of one of four dietary supplements:
Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides
processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods),
Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be
examined by PCR to determine content of bifidobacteria and total bacteria. This study is
limited to formula fed infants in order to avoid the confounding effects of the human milk
oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled
and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate
containing humna milk oligosaccharides) or powdered human milk fortifier for comparison
Inclusion Criteria:
- Born in or transferred to UCDMC within the first two weeks of life. Birth weight less
than 1500 grams. Gestational age less than 33 completed weeks. Exclusively formula
fed.
Exclusion Criteria:
- Gastrointestinal or cardiac anomalies.
We found this trial at
1
site
Click here to add this to my saved trials
