Healthy ParticipantsNCT05492253
First Complementary Foods and the Infant Gastrointestinal Microbiota
A study testing Infant fruit, Infant vegetable and Infant meat in people with Healthy Participants and Infants, run by University of Delaware at 1 site in United States.
Trial summary
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Infants, Gastrointestinal Microbiota
- What is being tested?
- Infant fruit, Infant vegetable and Infant meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant was born vaginally
- Infant was born full term
- Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
- Infant is at least 5 months old, but not 8 or more months old
- Infant consumes an exclusively human milk liquid diet only
- Infant has not yet begun consuming solid foods
Show all 10Show fewer
- Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
- Infant has not had antibiotics within the past month
- Infant's nursing mother has not had antibiotics within the past month
- Parent/legal guardian is at least 18 years old
Who cannot join
- Infant is not developmentally ready to begin solid foods
- Infant has a family history of food allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
Read the detailed description
The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.
- Conditions
- Healthy Participants, Infants, Gastrointestinal Microbiota
- Being tested
- Infant fruit, Infant vegetable, Infant meat, Infant grain
- Keywords
- Healthy term infant, Complementary diet, Gastrointestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant fruitOther
Infants will be fed prune puree
Infant vegetableOther
Infants will be fed carrot puree
Infant meatOther
Infants will be fed beef puree
Infant grainOther
Infants will be fed oatmeal cereal
| Study group | Role | What they receive |
|---|---|---|
| Infant cereal | Active comparator | Oatmeal cereal Receives: Other: Infant grain |
| Infant fruit | Experimental | Pureed prunes Receives: Other: Infant fruit |
| Infant vegetable | Experimental | Pureed carrots Receives: Other: Infant vegetable |
| Infant meat | Experimental | Pureed beef Receives: Other: Infant meat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal microbiota
Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food
Measured: Day 0, 3, 7, 10, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start30 Jan 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Nutrition
- Responsible party
- Principal investigator, Jill Trabulsi, University of Delaware
- Investigators
- Jillian Trabulsi, PhD, RD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492253
- Sponsor's protocol ID
- 1889964-1
- Status last verified
- May 2024
- First submitted
- 26 Jul 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferro LE, Bittinger K, Trudo SP, Kim JK, Hunt CM, Brewer B, Polson SW, Trabulsi JC. Influence of Singular First Foods on the Infant Gut Microbiome: A Randomized Controlled Trial. J Nutr. 2026 May;156(5):101470. doi: 10.1016/j.tjnut.2026.101470. Epub 2026 Mar 11.
PubMed 41825736
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
- ClinicalTrials.gov ID
- NCT05492253
- Acronym / sponsor ID
- 1889964-1
- Conditions
- Healthy Participants, Infants, Gastrointestinal Microbiota
- Keywords
- Healthy term infant, Complementary diet, Gastrointestinal microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- American Society for Nutrition
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.
Detailed description
The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infant cereal | Active comparator | Other: Infant grainOatmeal cereal |
| Infant fruit | Experimental | Other: Infant fruitPureed prunes |
| Infant vegetable | Experimental | Other: Infant vegetablePureed carrots |
| Infant meat | Experimental | Other: Infant meatPureed beef |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Infant was born vaginally
- Infant was born full term
- Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
- Infant is at least 5 months old, but not 8 or more months old
- Infant consumes an exclusively human milk liquid diet only
Key exclusion criteria (2 listed)
- Infant is not developmentally ready to begin solid foods
- Infant has a family history of food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant fruitInfants will be fed prune puree | Other | Infant fruit |
| Infant vegetableInfants will be fed carrot puree | Other | Infant vegetable |
| Infant meatInfants will be fed beef puree | Other | Infant meat |
| Infant grainInfants will be fed oatmeal cereal | Other | Infant cereal |
Primary outcome
Change in gastrointestinal microbiota
Time frame: Day 0, 3, 7, 10, 14
Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 41825736Ferro LE, Bittinger K, Trudo SP, Kim JK, Hunt CM, Brewer B, Polson SW, Trabulsi JC. Influence of Singular First Foods on the Infant Gut Microbiome: A Randomized Controlled Trial. J Nutr. 2026 May;156(5):101470. doi: 10.1016/j.tjnut.2026.101470. Epub 2026 Mar 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jillian Trabulsi, PhD, RD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant fruit, Infant vegetable and Infant meat in people with Healthy Participants and Infants, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal microbiota (time frame: Day 0, 3, 7, 10, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.