Effect of Probiotics on Infant's Fecal Microbiota Composition (NCT05524649) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Probiotics on Infant's Fecal Microbiota Composition
Mexico, Spain120 participantsStarted 2022-06-01
Plain-language summary
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Who can participate
Age range
1 Day – 90 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
* Age between 1 and 90 days
* Gestational age between 37 and 42 weeks
* Appropiate birth weight for gestational age (between P10 and P90)
* APGAR test score for birth normal at 1' and 5' of 7-10
* Whose parents accept the follow-up of the study procedures and sign the informed consent
Exclusion Criteria:
* Infants participating in other clinical study
* Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study
* Infants who have taken antibiotics 4 weeks prior the start study
* Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases
* Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition
* Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant
* TORCH complex infections
* Every other diseases related with the immune system
* Parents who can not accomplish the follow-up of the study (medical criterium)
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
Change of Bifidobacterium longum and Pediococcus pentosaceus in feces