A Phase 1 interventional study of ProlactPlus and GOS galacto-oligosaccharides in Fecal Microflora in the Formula Fed Premature Infant, sponsored by University of California, Davis. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by University of California, Davis · Phase 1, Interventional, and Prevention
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.
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
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 59 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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Exclusion Criteria:
Permeate
Dietary Supplement: ProlactPlus
GOS
Dietary Supplement: GOS galacto-oligosaccharides
Bifidobacterium infantis
Dietary Supplement: Bifidobacterium infantis
Bifidobacterium animalis
Dietary Supplement: Bifidobacterium animalis
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.
Also known as: human milk 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.
Also known as: galacto-oligosaccharides
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.
Also known as: bifidobacteria, B. infantis
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.
Also known as: B. animalis, bifidobacteria
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
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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University of California, Davis