Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiot… (NCT04304014) | Clinical Trial Compass
CompletedNot Applicable
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
Spain120 participantsStarted 2020-03-05
Plain-language summary
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10\^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10\^9 CFU) once a day.
Who can participate
Age range
25 Days
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:
* Healthy infants up to 25 days of life
* Infants with adequate weight according to the gestational age.
* Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
* Gestational birth equal or greater than 37 weeks.
* Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day).
Exclusion Criteria:
* Infants with smoker mother during pregnancy and after delivery.
* Infants whose parents cannot follow the study requirements
* Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
* Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
* Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
* Infants who ingest special formulas as extensively hydrolysed formulas.
* Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
* Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
* Infants undergoing therapies with…
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
Relative abundance of bifidobacteria
Timeframe: 1 month
Trial details
NCT IDNCT04304014
SponsorFundacion Clinic per a la Recerca Biomédica