Can a probiotic drop shape a Newborn's gut?
NCT ID NCT07882537
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Researchers are studying whether a probiotic supplement given to healthy preterm and full-term infants changes the bacteria in their gut. The trial includes infants born by caesarean section, starting the drops about 48 hours after birth for 28 days. Scientists compare infants who receive the probiotic with those who receive a placebo, checking stool samples for the probiotic strain and looking at overall gut bacterial balance, bowel movements, colic, growth, and general health over 84 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a probiotic supplement containing Lactobacillus paracasei DG
- What this could lead to
- If it works, this could offer a simple way to shape gut bacteria in newborns, especially those born by caesarean section who may miss some early microbes.
- What could go wrong
- The trial is small and early, so any effects on gut bacteria may not translate into clear health benefits. Probiotics can cause mild digestive upset, and preterm infants need careful monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
61 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
-
Jun 2020
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
0 to 48 hours
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 0-48 hours old; * Infants of both sexes with a birth weight ≥1000g; * Infants delivered by caesarean section; * Written informed consent from the infants' parents/guardians. Exclusion Criteria: * Vaginal delivery; * Extremely low birth weight (ELBW) (\<1000g); * Confirmed or suspected systemic infection; * Known severe neurological disease; * Known severe metabolic disease; * Known genetic disease and chromosome disorders; * Known severe maternal primary or secondary immunodeficiency; * Serious malformations (e.g. short bowel syndrome; intestinal occlusion; patency of the arterial duct may be included if asymptomatic and not requiring treatment); * Known maternal food allergies; * Maternal diabetes (including gestational diabetes); * Recent or suspected history of alcohol or drug abuse in the mother; * Any severe condition the investigator deems capable of interfering with treatment; * Inadequate reliability or presence of conditions capable of resulting in non-conformity or non-compliance of the patient with the protocol. * Administration of different probiotics other than the investigational product to the infant following start of the study. * Use of probiotics by a breastfeeding mother following start of the study. Only for NBW: * Systemic antibiotic treatment or prophylaxis from birth and throughout the duration of the study; * Systemic antibiotic treatment or prophylaxis by a breastfeeding mother (of an NBW infant) over the 30 days prior to the trial and throughout the duration of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gut microbiota modulation are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Neonatology Unit Policlinico Casilino
Roma, Roma, 00169, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.