Restoration of the Gut Microbiome After Cesarean Section (NCT06264219) | Clinical Trial Compass
RecruitingPhase 1
Restoration of the Gut Microbiome After Cesarean Section
Denmark80 participantsStarted 2024-08-02
Plain-language summary
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Gestational age \< week 38+0 days
* Proficient in spoken/written Danish
* Single pregnancy (no twins or triplets)
* Pre-pregnancy BMI between 18.5 and 35 kg/m2
* No chronic intestinal, endocrine, cardiac, or kidney disorders
* No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)
* No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.
* Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).
Exclusion Criteria:
Maternal:
* Use of antibiotics within one month of stool donation
* Acute gastroenteritis within one month of stool donation
* Use of antibiotics within one month of birth
* Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk)
* Positive test results for pathogens during donor material screening.
* Antibiotic treatment at birth (vaginal births only)
* Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.
Infant:
* Instances of major birth defects or intrauterine growth retardation (IUGR)
* Infants requiring pediatric support at the time of transplant administration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microbial compositional differences compared with placebo-treated infants