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A longitudinal observational study of the molecular dynamics and microbial profile in mediating relapse-remission in ulcerative colitis patients

A longitudinal observational study of the molecular dynamics and microbial profile in mediating relapse-remission in ulcerative colitis patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073432
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Ulerative Colitis

Interventions

Sponsors

Hong Kong Baptist University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years. 2. Has previously diagnosed of ulcerative colitis. 3. Had colonoscopy with biopsy within 12months and full Mayo score > 3 (colonoscopy score < 3) before study entry. 4. Individuals should fully understand what is involved in this study and give documented consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who meet one of the following criteria will be excluded: 1. Individual who unwilling to provide screening biopsy, blood or stool. 2. Individual who has been taken antibiotics or/and probiotics in the past one month. 3. Abnormal colonoscopy and biopsy pathology report, such as crypt epithelial dysplasia (intraepithelial neoplasia) or cancerous. 4. Intestinal stenosis. 5. Infectious enteritis or any suspicion of the presence of infectious enteritis (e.g., present of positive in the clostridium difficile test). 6. Laparotomy or laparoscopic surgery, surgery for hemorrhoids or perianal abscess, endoscopic mucosal resection or endoscopic intestinal dilation or endoscopic intestinal dilatation of the colon within 60 days before eligibility determination. 7. History of resection of the small intestine, cecum, colon or rectum. 8. Individuals with moderate or severe hepatic or renal disease or clinically significant bleeding disorder. 9. Individuals with any serious comorbid disease, such as hematological, respiratory, cardiovascular, or neuropsychiatric disease, or metabolic/electrolyte abnormality. 10. Individuals undergoing treatment or follow-up under 5 years for a malignant tumor. 11. History of alcohol or drug abuse. 12. Pregnant and nursing women and women suspected of being pregnant. 13. Individuals who are participating in any other clinical researches at study entry. 14. Others whom the investigator or co-investigator considered inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
Tissue biopsy transcriptomes ;serum inflammatory cytokines profiles;Longitudinal variance in gut microbial over a year;

Secondary

MeasureTime frame
Full Mayo score;Partial Mayo score;IBD questionnaire (IBDQ);

Countries

China

Contacts

Public ContactBian Zhaoxiang

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

bianzxiang@gmail.com+852 3411 2905

Outcome results

None listed

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