Donor milk for Microbial Colonization

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Microbial Colonization+4 MoreDonor milk - Other
Eligibility
1 - 96
All Sexes
What conditions do you have?
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Study Summary

This trial will compare banked donor milk to formula for breastfeeding late preterm infants born in San Francisco to assess growth and impacts on the type of bacteria in the baby's intestine.

Eligible Conditions
  • Microbial Colonization
  • Premature Baby
  • Breast Milk Substitute Intolerance
  • Growth Delay
  • Breastfeeding

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: 1 week and 1 month after enrollment

Month 1
Bifidobacteria
Clostridium
Lactobacillus
Day 7
Weight change

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Donor milk
1 of 2
Preterm infant formula
1 of 2

Active Control

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Donor milk · Has Placebo Group · N/A

Preterm infant formula
Other
PlaceboComparator Group · 1 Intervention: Preterm infant formula · Intervention Types: Other
Donor milk
Other
ActiveComparator Group · 1 Intervention: Donor milk · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week and 1 month after enrollment

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,279 Previous Clinical Trials
11,577,240 Total Patients Enrolled
1 Trials studying Microbial Colonization
324 Patients Enrolled for Microbial Colonization
University of California, DavisOTHER
841 Previous Clinical Trials
5,003,360 Total Patients Enrolled
4 Trials studying Microbial Colonization
447 Patients Enrolled for Microbial Colonization
Valerie Flaherman, MD, MPHPrincipal InvestigatorUniversity of California, San Francisco
5 Previous Clinical Trials
4,115 Total Patients Enrolled
1 Trials studying Microbial Colonization
324 Patients Enrolled for Microbial Colonization

Eligibility Criteria

Age 1 - 96 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The clinical team plans to start supplementation with vitamin D in the near future to help improve the health of their patients.