Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO) (NCT07302477) | Clinical Trial Compass
CompletedNot Applicable
Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)
Pakistan125 participantsStarted 2021-07-29
Plain-language summary
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs in a real-world setting. In addition to it considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas.
Who can participate
Age range
7 Days – 2 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
. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) has been informed of all pertinent aspects of the study
. Parent(s) Are willing and able to fulfill the requirements of the study protocol
. Healthy full term (37-42 weeks gestation) infant
. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
. Parent(s) must have independently elected, before enrollment, to formula feed. IF or mixed feeding. Prior to enrollment parents were counselled about the superiority and advantages of exclusive breastfeeding.
Exclusion criteria
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
World Health Organization (WHO) based weight-for-age z-scores Weight-for-age z-scores using WHO growth standards [Time Frame: 8 weeks (study end)]
Timeframe: 8 Weeks (Study End)
2
World Health Organization (WHO) based length-for-age z-scores
Timeframe: 8 Weeks (Study End)
3
World Health Organization (WHO) based weight-for-age z-scores
Timeframe: 8 Weeks (Study End)
4
World Health Organization (WHO) based weight-for-age z-scores
Timeframe: 8 Weeks (Study End)
5
World Health Organization (WHO) based weight-for-age z-scores
Timeframe: 8 Weeks (Study End)
6
Feeding Tolerance
Timeframe: 4 Weeks (Midpoint) and 8 Weeks (Study End Point)