Prebiotic for Infant Development

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Infant Development+2 MorePrebiotic - DietarySupplement
Eligibility
7 - 10
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal is to compare weight, length, and head circumference Z-score growth between the study and placebo groups.

Eligible Conditions
  • Infant Development
  • Premature Baby
  • Nutrition

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Enrollment through study day 45

Day 45
Adaptation
Fecal microbiome
Gut inflammation
Head Circumference
Length
Neurobehavior
Weight

Trial Safety

Trial Design

2 Treatment Groups

Experimental
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

90 Total Participants · 2 Treatment Groups

Primary Treatment: Prebiotic · Has Placebo Group · N/A

Experimental
DietarySupplement
Experimental Group · 1 Intervention: Prebiotic · Intervention Types: DietarySupplement
Control
DietarySupplement
PlaceboComparator Group · 1 Intervention: Dextrose Control · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prebiotic
2016
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment through study day 45

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
311 Previous Clinical Trials
5,216,347 Total Patients Enrolled
1 Trials studying Infant Development
130 Patients Enrolled for Infant Development

Eligibility Criteria

Age 7 - 10 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are the mother of a newborn who is in the neonatal intensive care unit.
Subjects have voluntarily signed and dated an informed consent form (ICF)