Baby formula with probiotics may improve poop regularity in infants
NCT ID NCT06159088
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a special infant formula containing probiotics and hydrolyzed whey protein can improve gut health in newborns. 240 healthy, full-term infants were assigned to receive either the test formula, a standard formula, or breast milk for 12 months. The main goal was to see if the test formula led to more regular bowel movements. Researchers also looked at stool consistency and overall growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- probiotics and hydrolyzed whey protein in infant formula
- What this could lead to
- If the formula works, it could offer a way to support regular bowel movements and gut health in formula-fed infants.
- What could go wrong
- This is a single completed study with modest outcomes (stool frequency). Results may not apply to all infants, and the product is not a treatment for any disease.
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
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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
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240 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Apr 2025
- Lead sponsor
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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
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1 day to 28 days
- Sex
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Anyone
- Healthy volunteers
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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: * Newborn baby, study entry before weaning (within 28 days of birth) * Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group). * Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age). * Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.). * Signed informed consent obtained for infant's participation in the study. * Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study. Exclusion Criteria: * History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant. * Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion). * Evidence of growth problems or concern for growth. * Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth. * Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury. * Use of probiotics/prebiotics before the study.
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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
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Jinhua Nanyuan Community Health Center
Jinhua, Zhejiang, China
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Li Pu Community Hospital
Jinhua, Zhejiang, China
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Qiu Bin Community Hospital
Jinhua, Zhejiang, China
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