Obesity, ChildhoodNCT03751137
GI Tract Biomarkers in Infants With Different Diets
An observational study of Obesity, Childhood, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Read more about this study
- Who is it for?
- Ages 6 weeks to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2016to 30 May 2025
- Phase
- Observational
- 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 6 weeks to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants who are either exclusively breast feeding or exclusively formula feeding are eligible to enroll if meeting other criteria.
Who may be able to join
- Otherwise healthy, male or female term infants
- Exclusively breast or formula feeding
- Never been exposed to oral or intravenous antibiotics or probiotics
Who cannot join
- Maternal antibiotic use while breast-feeding
- Infant or maternal use of probiotics
- Current or recent (<14 days) gastrointestinal infection (viral, bacterial, or fungal)
- Gastrointestinal mucosal disease, or significant constipation
- Consuming formula that is not standard cow's milk formula
- Infants on acid suppression medications or infants receiving high-density formula (>20 calories/ounce) may be enrolled and will be analyzed separately
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Hospital - Delaware
Wilmington, Delaware, 19803
About this study
Official title: Longitudinal, Prospective Comparison of the Gastrointestinal Tract of Breastfed and Formula Fed Infants Via Fecal Analysis of the Microbiome, Intestinal Epithelial Cell Expression of Gut Hormones, and Fecal Analysis of the Metabolome
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. The project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.
- Conditions
- Obesity, Childhood
- Keywords
- Microbiome, Gut-brain axis, Satiety, Hormone, Obesity, Metabolome
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Feeding | Infants who, when enrolled, are exclusively breast feeding. | |
| Formula Feeding | Infants who, when enrolled, are exclusively formula feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
Metagenomic analysis of microbial organisms in infant's feces
Measured: Enrollment
Microbiome
Metagenomic analysis of microbial organisms in infant's feces
Measured: 6 months
Microbiome
Metagenomic analysis of microbial organisms in infant's feces
Measured: 12 months
Microbiome
Metagenomic analysis of microbial organisms in infant's feces
Measured: 18 months
Secondary outcomes (8)
Metabolome
Metabolic products present in infant's feces
Measured: Enrollment
Metabolome
Metabolic products present in infant's feces
Measured: 6 months
Metabolome
Metabolic products present in infant's feces
Measured: 12 months
Metabolome
Metabolic products present in infant's feces
Measured: 18 months
Gut hormone gene expression
Transcriptional output of human epithelial cells in infant's feces
Measured: Enrollment
Gut hormone gene expression
Transcriptional output of human epithelial cells in infant's feces
Measured: 6 months
Gut hormone gene expression
Transcriptional output of human epithelial cells in infant's feces
Measured: 12 months
Gut hormone gene expression
Transcriptional output of human epithelial cells in infant's feces
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start10 Mar 2016
- Primary completion31 Jul 2021
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Principal investigator, Matthew Di Guglielmo, Nemours Children's Clinic
- Investigators
- Matthew Di Guglielmo, MD PhD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751137
- Sponsor's protocol ID
- 822736
- Status last verified
- May 2025
- First submitted
- 16 Nov 2018
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will release deidentified metagenomic sequencing data from each participant to either database of Genotypes and Phenotypes (dbGaP) or Sequence Read Archive (SRA).
Publications
Di Guglielmo MD, Franke KR, Robbins A, Crowgey EL. Impact of Early Feeding: Metagenomics Analysis of the Infant Gut Microbiome. Front Cell Infect Microbiol. 2022 Mar 4;12:816601. doi: 10.3389/fcimb.2022.816601. eCollection 2022.
PubMed 35310842Di Guglielmo MD, Franke K, Cox C, Crowgey EL. Whole genome metagenomic analysis of the gut microbiome of differently fed infants identifies differences in microbial composition and functional genes, including an absent CRISPR/Cas9 gene in the formula-fed cohort. Hum Microb J. 2019 Jun;12:100057. doi: 10.1016/j.humic.2019.100057. Epub 2019 May 25.
PubMed 34278055
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal, Prospective Comparison of the Gastrointestinal Tract of Breastfed and Formula Fed Infants Via Fecal Analysis of the Microbiome, Intestinal Epithelial Cell Expression of Gut Hormones, and Fecal Analysis of the Metabolome
- ClinicalTrials.gov ID
- NCT03751137
- Acronym / sponsor ID
- 822736
- Conditions
- Obesity, Childhood
- Keywords
- Microbiome, Gut-brain axis, Satiety, Hormone, Obesity, Metabolome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 23 Nov 2018 (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.
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity. It is not yet known how obesity develops in an individual, specifically in early childhood. Further, it is unclear what mechanistic role a child's earliest nutrition or changing intestinal flora has in the etiology of obesity. Very young children are developing appetite and satiety patterns early in life. Nutrition and gut microbial flora have impact on how these processes unfold, but specific mechanisms are not yet well understood. The investigators hypothesize that formula-fed infants with changes in their microbial flora are more likely to have altered carbohydrate metabolism, evidenced by greater imbalances of fatty acid production, and are more likely to have accelerated growth trajectory due to satiety disruption. The investigators further hypothesize that altered carbohydrate metabolism, e.g. imbalances of short- and long-chain fatty acid levels in the gut, stimulate cellular stress and affect specific gut hormones. This study will compare the microbiome of the intestinal microbial flora in two groups of infants, one breast fed and the other formula fed, using longitudinally collected fecal samples from both groups. Samples will be subjected to shotgun metagenomic analysis and simultaneous metabolomic analysis. A bioinformatics approach will elucidate key differences among and between sample groups, and will further analyze bacterial gene expression levels related to carbohydrate metabolism. This study will compare the expression of human proteins involved in cellular stress response and gut peptide signaling by applying quantitative Reverse Transcriptase-Polymerase Chain Reaction to human messenger RNA isolated from the longitudinally collected samples from both groups. Finally, this study will monitor the trajectory of growth and feeding over the first 2 years of life. The project's focus on the influence of different early feeding types, microbial flora changes, and altered carbohydrate metabolism leading to disruption of gut-brain signaling will provide critical data for host:microbiome interactions and translational therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Feeding | – | –Infants who, when enrolled, are exclusively breast feeding. |
| Formula Feeding | – | –Infants who, when enrolled, are exclusively formula feeding. |
Who may qualify
- Ages
- 6 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants who are either exclusively breast feeding or exclusively formula feeding are eligible to enroll if meeting other criteria.
Key inclusion criteria (3 listed)
- Otherwise healthy, male or female term infants
- Exclusively breast or formula feeding
- Never been exposed to oral or intravenous antibiotics or probiotics
Key exclusion criteria (6 listed)
- Maternal antibiotic use while breast-feeding
- Infant or maternal use of probiotics
- Current or recent (<14 days) gastrointestinal infection (viral, bacterial, or fungal)
- Gastrointestinal mucosal disease, or significant constipation
- Consuming formula that is not standard cow's milk formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome
Time frame: Enrollment
Metagenomic analysis of microbial organisms in infant's feces
Microbiome
Time frame: 6 months
Metagenomic analysis of microbial organisms in infant's feces
Microbiome
Time frame: 12 months
Metagenomic analysis of microbial organisms in infant's feces
Microbiome
Time frame: 18 months
Metagenomic analysis of microbial organisms in infant's feces
8 secondary outcomes
Metabolome
Time frame: Enrollment
Metabolome
Time frame: 6 months
Metabolome
Time frame: 12 months
Metabolome
Time frame: 18 months
Gut hormone gene expression
Time frame: Enrollment
Gut hormone gene expression
Time frame: 6 months
Gut hormone gene expression
Time frame: 12 months
Gut hormone gene expression
Time frame: 18 months
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 4 Jun 2025.
- Results publication: PubMed 35310842Di Guglielmo MD, Franke KR, Robbins A, Crowgey EL. Impact of Early Feeding: Metagenomics Analysis of the Infant Gut Microbiome. Front Cell Infect Microbiol. 2022 Mar 4;12:816601. doi: 10.3389/fcimb.2022.816601. eCollection 2022.
- Results publication: PubMed 34278055Di Guglielmo MD, Franke K, Cox C, Crowgey EL. Whole genome metagenomic analysis of the gut microbiome of differently fed infants identifies differences in microbial composition and functional genes, including an absent CRISPR/Cas9 gene in the formula-fed cohort. Hum Microb J. 2019 Jun;12:100057. doi: 10.1016/j.humic.2019.100057. Epub 2019 May 25.
- Individual participant dataSharing planned: Yes. We will release deidentified metagenomic sequencing data from each participant to either database of Genotypes and Phenotypes (dbGaP) or Sequence Read Archive (SRA).
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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.
Matthew Di Guglielmo, MD PhD principal investigator
Nemours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by Nemours Children's Clinic 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 3 inclusion and 6 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 4 Jun 2025. 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?
Microbiome (time frame: Enrollment). The study lists 4 primary outcomes in all. 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 NCT03751137, which also lists 2 linked publications.
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 4 Jun 2025.