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New treatment option for Microbial Colonization
Official title DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
ClinicalTrials.gov ID: NCT06177184
What this study is testing
- What it's testing
- The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 37 and older. Healthy volunteers may be eligible.
You may be able to join if
- Gestation greater than 37 weeks gestation (full-term)
- Caesarean Section delivery
- Intending to breastfeed
- Consent for infant to receive DHM
- Working understanding (proficient in reading and understanding) of English
You likely can't join if
- Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
- No intention to breastfeed
See the full eligibility criteria
- Gestation greater than 37 weeks gestation (full-term)
- Caesarean Section delivery
- Intending to breastfeed
- Consent for infant to receive DHM
- Working understanding (proficient in reading and understanding) of English
- Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
- In the investigator's opinion, the subject mother understands and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
- Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth
- No intention to breastfeed
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 37 weeks and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.