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Prebiotic

Prebiotic for Premature Infants

N/A

Waitlist Available

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment through study day 45

Awards & highlights

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.

Who is the study for?

This trial is for preterm infants born between 26 and 32 weeks gestation, weighing 700 to 1800 grams. Eligible babies must have parents or guardians who consent by day 10 after birth, plan to provide human milk (mother's own or donor), and not have certain health conditions like severe brain hemorrhage, congenital anomalies, necrotizing enterocolitis, sepsis, steroid use at randomization time, ventilator dependence over two days before enrollment or maternal substance abuse.Check my eligibility

What is being tested?

The study tests the effects of adding a prebiotic to the diet of premature infants fed with human milk. It's a double-blind trial where neither doctors nor participants know who gets the prebiotic or placebo. The main goal is to see if there are differences in growth measurements and how quickly full feedings are reached. Neurodevelopmental outcomes and changes in gut inflammation and microbiome will also be explored.See study design

What are the potential side effects?

Potential side effects from prebiotics may include digestive discomfort such as gas or bloating due to changes in gut bacteria activity. However, specific side effects will be monitored throughout this particular study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment through study day 45

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment through study day 45

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through study day 45 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Head Circumference

Length

Weight

Secondary outcome measures

Adaptation

Other outcome measures

Fecal microbiome

Gut inflammation

Neurobehavior

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Experimental Arm

Group II: ControlPlacebo Group1 Intervention

Placebo Control Arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prebiotic

2016

Completed Phase 2

~720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,459 Total Patients Enrolled

1 Trials studying Infant Development

130 Patients Enrolled for Infant Development

Media Library

Prebiotic (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03306316 — N/A

Infant Development Research Study Groups: Experimental, Control

Infant Development Clinical Trial 2023: Prebiotic Highlights & Side Effects. Trial Name: NCT03306316 — N/A

Prebiotic (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03306316 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include members of the geriatric population?

"As outlined in the trial's enrollment requirements, infants between 7 and 10 days old are eligible to participate."

Answered by AI

Is it possible to get enrolled in this medical experiment?

"This trial is searching for 90 preterm infants that were born between 700 and 1800g, ranging from 26 weeks to 31 6/7 weeks of gestation. In order to be considered, a signed parental consent must be obtained by 10 days post-birth, as well as the mother's agreement to either provide her own milk or accept donated human milk in NICU."

Answered by AI

Is enrollment currently open for volunteers to participate in this medical experiment?

"Data provided on clinicaltrials.gov confirms the active recruitment of patients for this medical trial, which was initially posted July 4th 2018 and last updated September 21st 2022."

Answered by AI

How many participants are taking part in this clinical experiment?

"Affirmative. Clinicaltrials.gov attests to the fact that, as of September 21st 2022, this medical experiment is still recruiting participants - a process which began on July 4th 2018. A total of 90 subjects need to be enlisted from one single site for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prebiotic in Preterm Infants

Ethan Mezoff 2018. "Prebiotic in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03306316.