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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03151850
Other study ID # 2015SDU-QILU-G004
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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