Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of P… (NCT04584320) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
France40 participantsStarted 2021-10-18
Plain-language summary
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.
Who can participate
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.
Inclusion Criteria:
* Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
* Affiliated or beneficiary of a health insurance plan.
* Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.
Exclusion Criteria:
* Newborn with malformative digestive pathology
* Newborn baby participating in another category 1 trial
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
Presence of C. butyricum
Timeframe: Each day of hospitalization (maximum 120 days)
2
Presence of C. neonatale
Timeframe: Each day of hospitalization (maximum 120 days)
3
Culture of C. butyricum
Timeframe: Each day of hospitalization (maximum 120 days)
4
Culture of C. neonatale
Timeframe: Each day of hospitalization (maximum 120 days)