The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Microflora in the Formula Fed Premature Infant |
Dietary Supplement: ProlactPlus Dietary Supplement: GOS galacto-oligosaccharides Dietary Supplement: Bifidobacterium infantis Dietary Supplement: Bifidobacterium animalis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants |
- 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). [ Time Frame: six weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Permeate
|
Dietary Supplement: ProlactPlus
Group 1 infants will be fed a concentration of Permeate mixed with formula. The ProlactPlus will be increased each week as follows: week 1 95:5 (formula:ProlactPlus), week 2 90:10, week 3 85:15, week 4 80:20, and week 5 75:25. Caloric content is roughly as follows: week 1 21 cal/oz, week 2 22 cal/oz, week 3 23 cal/oz, week 4 24 cal/oz, and week 5 25 cal/oz.
Other Name: human milk oligosaccharides
|
|
Active Comparator: 2
GOS
|
Dietary Supplement: GOS galacto-oligosaccharides
Group 2 infants will have their formula supplemented with galacto-oligosaccharides (GOS) for each feeding as follows: week 1 0.25 g/dL, week 2 0.5 g/dL, week 3 1.0 g/dL, week 4 1.5 g/dL, and week 5 2.0 g/dL.
Other Name: galacto-oligosaccharides
|
|
Active Comparator: 3
Bifidobacterium infantis
|
Dietary Supplement: Bifidobacterium infantis
Group 3 infants will have their formula supplemented with B. infantis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
Other Names:
|
|
Active Comparator: 4
Bifidobacterium animalis
|
Dietary Supplement: Bifidobacterium animalis
Group 4 infants will have their formula supplemented with B. animalis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
Other Names:
|
Detailed Description:
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Majid Mirmiran, MD, PhD | 916-734-4790 | majid.mirmiran@ucdmc.ucdavis.edu |
| Contact: Mark A Underwood, MD | 916-762-7892 | mark.underwood@ucdmc.ucdavis.edu |
| United States, California | |
| UC Davis Medical Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Majid Mirmiran, MD, PhD 916-734-4790 majid.mirmiran@ucdmc.ucdavis.edu | |
| Contact: Mark A Underwood, MD 916-762-7892 mark.underwood@ucdmc.ucdavis.edu | |
| Principal Investigator: Mark Underwood, MD | |
| Sub-Investigator: David Mills, Ph.D. | |
| Principal Investigator: | Mark Underwood, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Mark Underwood, MD, UCD Health System |
| ClinicalTrials.gov Identifier: | NCT00810160 History of Changes |
| Other Study ID Numbers: | HD059127-01, R01HD059127 |
| Study First Received: | December 15, 2008 |
| Last Updated: | March 14, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of California, Davis:
|
probiotic prebiotic oligosaccharides GOS |
galacto oligosaccharides Bifidobacterium infantis Bifidobacterium animalis |
ClinicalTrials.gov processed this record on May 22, 2013