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Sweet potato vs. pear: which first food shapes Baby's gut best?

NCT ID NCT03229863

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how introducing solid foods like sweet potato or pear changes the gut bacteria of breastfed babies. Researchers will track 102 infants and their mothers to see how these first foods affect digestion, health, and early brain development. The goal is to learn how nutrition in infancy supports healthy growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sweet potato or pear baby food
What this could lead to
If successful, this could help understand how early foods shape a baby's gut health and development.
What could go wrong
This is an observational study with a small sample (102 infants). Results may not apply to all babies or feeding patterns.

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

102 people

The number who actually took part.

Started

Apr 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Women, age 21 to 45 years who have delivered a healthy single infant by vaginal delivery and their infants, age 4 to 7.5 months; * Infants who are developmentally ready for solids; * Generally healthy women and infants; * Mothers who plan to exclusively (without solids or infant formula) breastfeed (at the breast or feed breast milk by bottle) their infants for at least 5 months of age and plan to continue to breastfeed with solids and/or infant formula until 12 months of age; * Mothers who are willing to either use their own breast pump, or hand-express, or use a manual pump provided by the study to collect milk samples; * Mothers who are willing to refrain from feeding their infants infant formula, non-study solid foods; probiotic or iron supplements (confounding variables of the intestinal microbiome) before the end of the feeding intervention period; * Term infants born \>37 weeks gestation; * Mother-infant pairs who live within a 20-mile radius from University of California, Davis campus in Davis, California (includes Woodland, Vacaville, Dixon and surrounding areas) or within a 20-mile radius of the University of California, Davis Medical Center (UCDMC) (2221 Stockton Blvd, Sacramento, CA 95817). Exclusion Criteria: * Infants with any GI tract abnormalities; * Infants born by cesarean section; * Family history of immunodeficiency syndrome(s); * Multiple infants born to one mother at the same time (no twins, triplets, etc.); * Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection; * Mothers diagnosed with any metabolic or endocrine, liver, kidney disease, any autoimmune disease, cirrhosis, hepatitis C, HIV, AIDS, cancer, obesity (pre-pregnancy BMI \>34.9), polycystic ovary syndrome (PCOS), celiac disease, Crohn's disease, heart disease, hyper- or hypothyroidism, hyper- or hypotension (including pre-eclampsia), type 1 or type 2 diabetes. * Mothers who smoked cigarettes less than one month before becoming pregnant, during pregnancy, and currently or mothers who plan to initiate smoking during the study duration; * Infants who have taken antibiotics within the past 4 weeks; * Infants who have taken iron supplements within the past 4 weeks; * Infants who have consumed infant formula in the past 4 weeks; * Infants who have consumed infant formula more than 10 days between birth and 4 weeks prior to screening; * Infants who have consumed any solids; * Mothers who plan to feed infants solids before 5 months of age; * Mothers who plan to administer any probiotics to infants throughout the feeding intervention period (first 18 days of the study); * Infants who have consumed probiotics containing Bifidobacterium within the past 4 weeks or other probiotics within the past 7 days; * Mothers who live in more than one location (should only live in one house to ensure samples are correctly collected and stored); * Infants who have hypotonia, * Infants who have been diagnosed with any medical or nutritional condition that would require iron supplementation. * Infants who on average pass less than one stool per week.

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Conditions

The condition(s) this trial relates to.

Breast Feeding infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of California, Davis

    Davis, California, 95616, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.