Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05272566
Eligibility Criteria:
Inclusion criteria for infants
* The donor must be of term (\>37+0 weeks GA, \< 41+0 weeks GA),
* Be born vaginally with no maternal pre-birth infection,
* Be exclusively breastfed un till fulfilled donation at 4 weeks of age,
* Have no known predisposition for disease.
Exclusion criteria for infants
* Antibiotic exposure before collection of faecal material for donation,
* Disease between time of birth and collection of feces for donation,
* Major congenital anomalies or birth defects, perinatal asphyxia, need for mechanical ventilation or cardiovascular support before time of inclusion.
* Positive stool sample for C. difficile toxin, parasites or other pathogens
* Positive HIV, HBV, or HCV or CMV
* Parents who do not want to know the HIV, HBV or HCV status of the child
Inclusion criteria for mothers
* Women aged 18-45 and currently healthy
* No continuous medical consumption with effects on microbiome
* Non-smoking
* Ability to give informed consent
Exclusion criteria for mothers
* Known or high risk of infectious disease such as HIV, HBV, or HCV
* Positive CMV IgM during pregnancy
* Positive stool sample for C. difficile toxin, parasites or other pathogens
* Systemic antibiotic treatment \< 1 months prior to study
* New tattoo \< 1 month prior to study
* Risky sexual behavior
* Gestational diabetes
* Family history of inflammatory bowel disease
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05272566
Study Brief:
Protocol Section:
NCT05272566