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Matched Donor Human Milk for Premature Birth (MMOMSS Trial)

N/A

Recruiting

Led By Meghan B Azad, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Intestinal perforation or stage 2 necrotizing enterocolitis (NEC)

Presence prior to enrollment of intestinal perforation or stage 2 necrotizing enterocolitis (NEC) prior to tolerating fortified feeds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether matching a preterm infant's donor milk to their mother's secretor status impacts the gut microbiome.

Who is the study for?

This trial is for very preterm infants born before 34 weeks of gestation. Eligible babies must be able to receive donor human milk and have mothers who can consent and comply with the study's requirements. Infants with a high risk of not surviving, serious gut conditions like NEC, or those on long-term antibiotics are excluded.

What is being tested?

The MMOMSS Study is testing whether matching donated breast milk to an infant's mother's secretor status affects the baby’s gut bacteria. Preterm infants will either get matched donor milk or standard unmatched donor milk in this randomized control trial.

What are the potential side effects?

Since the intervention involves feeding with human breast milk, side effects may be minimal but could include potential allergic reactions or intolerance to certain components in the donor milk.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had an intestinal perforation or stage 2 necrotizing enterocolitis.

Select...

I had a bowel perforation or severe intestinal infection before starting solid foods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured when infant is discharged or transferred from unit, or up to 60 days, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fecal microbiome composition

Other study objectives

Days to full enteral feeds

Donor human milk composition - human milk oligosaccharide concentrations

Donor human milk composition - nutritional composition

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Matched donor human milkExperimental Treatment1 Intervention

Infants randomized to the matched donor human milk arm, will receive donor human milk which is matched to their mother's secretor status.

Group II: Standard issue donor human milkActive Control1 Intervention

Infants randomized to the standard issue donor human milk arm, will receive donor human milk which is prepared without consideration of secretor status as per standard practice.

0 / 2Eligibility criteria met