The Motility Mother-Child Cohort (NCT05491161) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Motility Mother-Child Cohort
Denmark250 participantsStarted 2022-08-22
Plain-language summary
The overall aim of the project is to investigate how bowel habits and nutrition in early life relate to the infant gut microbiome and metabolome from birth to 1 year of age. By unravelling links between these factors in early life, we might be able to identify new putative mechanisms by which diet via microbiota-dependent pathways affects intestinal motility in early life. Furtermore, it will be explored how the development of the gut microbiome associates with the child´s development.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Mothers Inclusion Criteria:
* Age: 18-40 years of age at inclusion
* Speaking Danish (since all written and oral information will be in Danish)
* Willing to store their child's biological samples in a small closed container in their own freezer at home
Mothers Exclusion Criteria:
* Gestational age more than 34 weeks at time of recruitment
* Diagnosed with gestational diabetes during this current pregnancy
* Diagnosed with preeclampsia during this current pregnancy
* Diagnosed with any severe or chronic diseases\*
* Expecting triplets or higher order of multiple pregnancy
* Concurrent participation in another study
* Not capable of following the examinations according to the investigator´s instructions
Infants Inclusion Criteria:
\- Gestational age at birth: 36 weeks or later
Infants Exclusion Criteria:
\- Severe chronic illness
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
Infant gut microbiome composition
Timeframe: Faecal samples collected bi-weekly from birth until 12 months