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Nutritional Replacement

Donor Human Milk for Infant Gut Health (PPDHM Trial)

N/A

Recruiting

Led By Meredith Brockway, PhD RN

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up twelve weeks postpartum

Awards & highlights

PPDHM Trial Summary

This trial will explore if DHM can improve microbiome, sleep, and growth in infants, and reduce depression and anger in mothers.

Who is the study for?

This trial is for full-term infants exposed to antibiotics during labor and their mothers who plan on breastfeeding. Eligible moms must understand English, agree to let their baby have donor milk, and be able to follow the study's rules. Babies with major birth defects affecting feeding or growth, or those needing long-term antibiotics beyond labor treatment can't join.Check my eligibility

What is being tested?

The study tests if using donated human milk instead of formula helps develop a healthier gut in babies given antibiotics at birth. It also looks at whether this affects infant sleep and growth, as well as maternal mood, confidence in breastfeeding, and rates of exclusive breastfeeding.See study design

What are the potential side effects?

Since the intervention involves nutritional replacement with donor human milk versus formula, side effects are not typical but may include potential allergic reactions or intolerance to donor milk.

PPDHM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ twelve weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~twelve weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and twelve weeks postpartum for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Infant gut microbiome - shallow shotgun metagenomics (RA)

Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)

Infant gut microbiome - shallow shotgun metagenomics (beta diversity)

Secondary outcome measures

Infant Growth - BMI

Infant Growth - head

Infant Growth - length

+8 more

PPDHM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Donor Human MilkExperimental Treatment1 Intervention

Infants randomized to the intervention group will receive DHM each time supplementation is required for the first 7 days of life.

Group II: Standard Care (Infant Formula)Active Control1 Intervention

Infants randomized to the standard care group will receive formula each time supplementation is required for the first 7 days of life.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,094 Total Patients Enrolled

4 Trials studying Microbial Colonization

1,350 Patients Enrolled for Microbial Colonization

University of British ColumbiaOTHER

1,418 Previous Clinical Trials

2,467,058 Total Patients Enrolled

3 Trials studying Microbial Colonization

219 Patients Enrolled for Microbial Colonization

NorthernStar Mothers Milk BankUNKNOWN

1 Previous Clinical Trials

90 Total Patients Enrolled

1 Trials studying Microbial Colonization

90 Patients Enrolled for Microbial Colonization

Media Library

Donor Human Milk (Nutritional Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05815433 — N/A

Microbial Colonization Research Study Groups: Donor Human Milk, Standard Care (Infant Formula)

Microbial Colonization Clinical Trial 2023: Donor Human Milk Highlights & Side Effects. Trial Name: NCT05815433 — N/A

Donor Human Milk (Nutritional Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05815433 — N/A

Frequently Asked Questions

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

Is there still availability for enrollment in this research endeavor?

"As per the information on clinicaltrials.gov, this trial is actively recruiting patients with a posting date of July 1st 2023 and most recent edit also occurring on that same day."

Answered by AI

How many patients can take part in the current research?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently open for recruitment and was initially posted on July 1st 2023 with the last update also being made on that date. The study requires 60 patients to enroll from one site."

Answered by AI

What goal is this clinical experiment attempting to achieve?

"The pivotal assessment of this twelve-week trial is the variation in infant gut microbiome - with shallow shotgun metagenomics employed to measure alpha diversity. Secondary objectives include measuring maternal depression through Edinburgh Postnatal Depression Screening (0-30), assessing infant sleep quality via Brief Infant Sleep Questionnaire (scaled 0-100) and tracking baby growth rate by calculating body mass index (kg/m^2)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

Meredith Brockway 2023. "Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05815433.