Clinical trial NCT03151850: The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis
Official title: The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: fungal
mucosa
diversity
Basidiomycete
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2017-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: fungus detection rate
timeFrame: 6 months
measure: yeasts detection rate
timeFrame: 6 months
measure: candida albicans detection rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2017 Jun;66(6):1039-1048. doi: 10.1136/gutjnl-2015-310746. Epub 2016 Feb 3.
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.
citation: 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. doi: 10.3389/fimmu.2013.00196. eCollection 2013.