Diarrhea InfantileNCT06356545
Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
An observational study of Diarrhea Infantile, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model. Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Infantile
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
Who may be able to join
- Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
- Patients with consent from parents or legal guardians
Who cannot join
- Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
- Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
- Functional diarrhea
- Patients with poor compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yanqiu Wang
Shanghai, Shanghai Municipality, 201102
Ying Huang, 02164931727, yhuang815@163.com
About this study
Official title: A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.
Read the detailed description
This study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (CODE), The investigator will mine biomarkers of CODE through multi-omics technology. This study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.
- Conditions
- Diarrhea Infantile
- Medical subject headings
- Diarrhea, Infantile
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 |
|---|---|---|
| Case | Congenital diarrhea and enteropathy (CODE) patients | |
| Control | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical phenotype of congenital diarrhea and enteropathy in China
Describe the clinical phenotype(Birth status, family history, clinical features of diarrhea, laboratory examination, endoscopic and histological evaluation results, growth and development indicators, previous treatment and effect were collected) of congenital diarrhea and enteropathy in China,We will use our own mobile application or to collect the relevant data, which will be filled in by the parents of the child.
Measured: Within approximately 2 years of enrollment
Secondary outcomes (2)
Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features
Plasma and stool were collected from patients and healthy control children for multi-omics screening to identify biomarkers, of which differential expression were mined through proteome(olink), microbiome(metagenomic sequencing) and metabolome( untargeted metabolomics)，relevant statistical analyses were performed using non-parametric tests, such as the Wilcoxon signed-rank test.
Measured: Within approximately 2 years of enrollment
Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning
Using artificial intelligence and machine learning to construct predictive models for congenital diarrhea and enteropathy by combining children's clinical phenotypes and multi-omics results，such as the random forest model
Measured: Within approximately 30 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start15 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea InfantileStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356545
- Sponsor's protocol ID
- OMICS_CODE_01
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
- ClinicalTrials.gov ID
- NCT06356545
- Acronym / sponsor ID
- OMICS_CODE_01
- Conditions
- Diarrhea Infantile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Apr 2024 (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 will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model.
Detailed description
This study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (CODE), The investigator will mine biomarkers of CODE through multi-omics technology. This study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Congenital diarrhea and enteropathy (CODE) patients |
| Control | – | –Healthy children |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
Key inclusion criteria (2 listed)
- Patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age
- Patients with consent from parents or legal guardians
Key exclusion criteria (4 listed)
- Chronic diarrhea caused by specific infections, i.e. CMV, Clostridioides difficile
- Chronic diarrhea with necrotizing enterocolitis, short bowel syndrome
- Functional diarrhea
- Patients with poor compliance
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
Clinical phenotype of congenital diarrhea and enteropathy in China
Time frame: Within approximately 2 years of enrollment
Describe the clinical phenotype(Birth status, family history, clinical features of diarrhea, laboratory examination, endoscopic and histological evaluation results, growth and development indicators, previous treatment and effect were collected) of congenital diarrhea and enteropathy in China,We will use our own mobile application or to collect the relevant data, which will be filled in by the parents of the child.
2 secondary outcomes
Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features
Time frame: Within approximately 2 years of enrollment
Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning
Time frame: Within approximately 30 months of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Related trials for Diarrhea Infantile
Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Infantile Colics, Constipation
Recruiting
Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty
Diarrhea, Infantile, Enteropathy
RecruitingPhase 1/2
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Acute Gastroenteritis
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Functional Gastrointestinal Disorders, Gastroesophageal Reflux
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.
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 Diarrhea Infantile, run by Children's Hospital of Fudan University at 1 site in China.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Huang, MD,PHD (+862164931727, yhuang815@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical phenotype of congenital diarrhea and enteropathy in China (time frame: Within approximately 2 years of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.