What is the mechanism of action of this treatment?

Common treatments for microbial colonization, such as Donor Human Milk (DHM), probiotics, and fecal microbiota transplantation (FMT), work by restoring and maintaining a healthy gut microbiome. DHM minimizes gut microbiome dysbiosis and fosters homeostasis by providing beneficial bacteria and nutrients. Probiotics introduce beneficial bacteria to outcompete harmful ones, while FMT transfers a diverse microbial community from a healthy donor to the patient. These treatments are crucial for patients as they help restore the natural balance of the gut microbiome, essential for overall health, digestion, and immune function.

What side effects are associated with this type of intervention?

Common treatments for microbial colonization, such as probiotics and prebiotics, are generally considered safe but can have side effects. Probiotics may cause mild digestive symptoms like gas, bloating, and diarrhea. In rare cases, they can lead to infections, particularly in immunocompromised individuals. Prebiotics, which are nondigestible carbohydrates that promote the growth of beneficial bacteria, can also cause gastrointestinal discomfort, including gas and bloating. It is important to note that while these treatments aim to improve gut microbiome health, they should be used with caution in certain populations, such as those with severe underlying health conditions.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at modulating the gut microbiome, including probiotics and prebiotics. Probiotics such as Lactobacillus and Bifidobacterium species are commonly used to promote a healthy gut microbiome. While specific FDA approvals for Donor Human Milk (DHM) are not mentioned, the concept of using DHM to minimize gut microbiome dysbiosis and foster homeostasis aligns with the broader category of microbiome-modulating therapies. These treatments are generally recognized as safe (GRAS) and are used to support gut health, particularly in infants and individuals with disrupted microbiomes.

What other types of research exist?

Promising alternatives to Donor Human Milk (DHM) for minimizing gut microbiome dysbiosis and fostering homeostasis include probiotics (e.g., Lactobacillus rhamnosus GG, Bifidobacterium breve) and synbiotics (combinations of probiotics and prebiotics). These interventions have shown efficacy in promoting beneficial gut microbiota and improving gut health.

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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

No Placebo-Only Group

Summary

This trial is testing whether giving donor human milk instead of formula to full-term infants can help maintain healthy gut bacteria. The study aims to see if this can improve the babies' sleep, growth, and overall health. The trial also looks at how this affects the mothers' mental health and breastfeeding success.

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.

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.

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.

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

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

Primary study objectives

Infant gut microbiome - shallow shotgun metagenomics (RA)

Infant gut microbiome - shallow shotgun metagenomics (alpha diversity)

Infant gut microbiome - shallow shotgun metagenomics (beta diversity)

Secondary study objectives

Infant Growth - BMI

Infant Growth - head

Infant Growth - length

+8 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: 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for microbial colonization, such as Donor Human Milk (DHM), probiotics, and fecal microbiota transplantation (FMT), work by restoring and maintaining a healthy gut microbiome. DHM minimizes gut microbiome dysbiosis and fosters homeostasis by providing beneficial bacteria and nutrients. Probiotics introduce beneficial bacteria to outcompete harmful ones, while FMT transfers a diverse microbial community from a healthy donor to the patient. These treatments are crucial for patients as they help restore the natural balance of the gut microbiome, essential for overall health, digestion, and immune function.