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Research on multi-omics and environmental risk factors for inflammatory bowel disease in south-central China

Research on the occurrence and development of inflammatory bowel disease based on multi-omics and environmental risk factor analysis: a longitudinal cohort study of adults and children with inflammatory bowel disease in south-central China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN38557825
Enrollment
500
Registered
2021-09-15
Start date
2021-09-01
Completion date
Unknown
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease (IBD), including Crohn's disease (CD), ulcerative colitis (UC) Digestive System Crohn disease [regional enteritis], Ulcerative colitis

Interventions

Baseline measurement (Spring 2021): For adult patients, when they are hospitalized in The Third Xiangya Hospital, they will be asked if they are willing to take part in the program and

Sponsors

Third Xiangya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients: 1. Patients with inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) or suspected IBD patients in The Third Xiangya Hospital and Hunan Children's Hospital 2. Be willing to take part in this program and provide written informed consent (if children, the consents are signed by the guardians) 3. All ages Controls: 1. Healthy participants from the Health Management Center of The Third Xiangya Hospital and Hunan Children's Hospital 2. All ages

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to cooperate with work due to mental or physical reasons 2. Healthy controls who have gastrointestinal diseases and symptoms

Design outcomes

Primary

MeasureTime frame
1. Multi-omics integrated analyses including blood metabolomics, fecal metabolomics, metagenomics, and metaproteomics, measured using the Illumina sequencing platform and liquid chromatograph-mass spectrometer (LC-MS) at baseline 2. Degree of disease activity measured by CDAI and Mayo score at baseline and follow-up (every 6 months for 3 years) 3. Degree of disease in endoscopy measured by UCEIS and CDEIS at baseline and follow-up (every 6 months for 3 years) 4. Degree of inflammation in vivo measured using hemoglobin, platelets, albumin, calprotectin and CRP tests at baseline and follow-up (every 6 months for 3 years) 5. Resistance to anti-TNFa measured by the concentration of antiantibody at follow-up (every 6 months for 3 years)

Secondary

MeasureTime frame
1. Genetic characteristics measured using whole gene sequencing at baseline 2. Environment factors measured using Algal toxins and heavy metals at baseline 3. Living habits and psychological factors measured using the Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder- 7 (GAD-7), and the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline and follow-up (every 6 months for 3 years)

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026