UnknownPhase 4

Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section

Italy60 participantsStarted 2017-06-01

Plain-language summary

The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.

Who can participate

Age range

1 Hour – 4 Months

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: * Term newborn * Adeguate for gestational age * Born by elective cesarean section * Otherwise healthy newborn Exclusion Criteria: * major acute or chronic disease * use of probiotics/antibiotics * gastrointestinal malformation, cystic fibrosis, other genetic diseases * concurrent participation in other clinical trials

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

Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample

Timeframe: 21 days after supplementation start

Number of participants with treatment-related adverse event

Timeframe: During 21 days after supplementation

Trial details

NCT IDNCT03154866

SponsorPoliclinico Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-31

View on ClinicalTrials.gov More Caesarean Section;Stillbirth trials