Effects of Complementary Feeding on Infant Growth and Gut Health (NCT05012930) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Complementary Feeding on Infant Growth and Gut Health
United States267 participantsStarted 2021-08-01
Plain-language summary
This study plans to learn more about how consuming different foods during the time of early complementary feeding (\~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.
The three primary aims include:
Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.
Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.
Aim 3. Identify gut microbial taxa and genes that affect infant growth.
Who can participate
Age range
4 Months – 60 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:
* Full term;
* Generally healthy without conditions that would affect protein metabolism or growth
* No previous complementary food exposure
* Vaginal delivery
* No prior exposure of antibiotics during delivery or after birth
* Able to consume study foods
* Single birth.
Exclusion Criteria:
* Pre-term infants.
* Having conditions that would affect normal growth
* Had complementary foods prior to the start of the study
* Not willing to consume the complementary foods provided
* Antibiotics exposure during delivery or from birth to 5 months of life
* Multiple births
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.