The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth (NCT06686433) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
China342 participantsStarted 2025-01-13
Plain-language summary
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
Who can participate
Age range
42 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
. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
. Healthy term infant (≥ 37 weeks of gestation).
. Infants birth weight ≥ 2500 and ≤ 4500 g.
. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.
Exclusion criteria
. Conditions requiring infant feedings other than those specified in the protocol.
. Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
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
Daily body weight gain between V1 and V3
Timeframe: From baseline to the age of 6 months
2
Fecal total pathogens load
Timeframe: From baseline to the age of 6 months
Trial details
NCT IDNCT06686433
SponsorBiostime (Guangzhou) Health Products Limited
. Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.
. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:
. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);