The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151850
• Other study ID #: 2015SDU-QILU-G004
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2016
• Last updated: May 10, 2017
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2017
• Source: Shandong University
• Contact: Xiuli Zuo, PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.

Description:

In recent years, the relationship of intestinal fungus with inflammatory bowel disease was gradually revealed. We divided the patients with ulcerative colitis into three groups on the basis of World Gastroenterology Organisation (WGO) classification about inflammation degree and progress classification and established the healthy control group. Analyzing the diversity of the fungal and bacterial within colon mucosa between patients with different clinical classification, for example, the proportion of bacteria and fungi, the proportion of candida albicans, the proportion of yeasts, and so on.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients at our tertiary care medical center, aged between 18 and 80 years, scheduled to undergo surveillance colonoscopy.

• The patients with ulcerative colitis for ulcerative colitis group.

• The patients without ulcerative colitis for control group.

• 18-80 years.

Exclusion Criteria:

• Using antibiotics, glucocorticoid and immunosuppressants wintin one month.

• There are contraindications for enteroscopy and biopsy.

• There are other intestinal diseases.

• Pregnancy or breast-feeding women.

• Patients with serious lung disease and mental illness.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• ulcerative colitis
We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.
• Control
We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Xiuli Zuo	Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (3)

Eriksson M, Johannssen T, von Smolinski D, Gruber AD, Seeberger PH, Lepenies B. The C-Type Lectin Receptor SIGNR3 Binds to Fungi Present in Commensal Microbiota and Influences Immune Regulation in Experimental Colitis. Front Immunol. 2013 Jul 16;4:196. do — View Citation

Mukhopadhya I, Hansen R, Meharg C, Thomson JM, Russell RK, Berry SH, El-Omar EM, Hold GL. The fungal microbiota of de-novo paediatric inflammatory bowel disease. Microbes Infect. 2015 Apr;17(4):304-10. doi: 10.1016/j.micinf.2014.12.001. Epub 2014 Dec 15. — View Citation

Sokol H, Leducq V, Aschard H, Pham HP, Jegou S, Landman C, Cohen D, Liguori G, Bourrier A, Nion-Larmurier I, Cosnes J, Seksik P, Langella P, Skurnik D, Richard ML, Beaugerie L. Fungal microbiota dysbiosis in IBD. Gut. 2016 Feb 3. pii: gutjnl-2015-310746. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fungus detection rate	Fungi detection rate was defined as the percentage of patients in whose colonic mucosa at least one kind of fungus were identified.	6 months
Primary	yeasts detection rate	Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.	6 months
Primary	candida albicans detection rate	Candida albicans detection rate was defined as the percentage of patients in whose colonic mucosa candida albicans were identified.	6 months

External Links

•   PUBmed
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