NCT03151850

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

December 19, 2016

Last Update Submit

May 10, 2017

Conditions

Ulcerative Colitis

Keywords

fungalmucosadiversityBasidiomycete

Outcome Measures

Primary Outcomes (3)

  • 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

  • yeasts detection rate

    Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.

    6 months

  • 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

Study Arms (2)

ulcerative colitis

We analysed the diversity of the fungal and bacterial in patients with Ulcerative Colitis (UC). We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.

Other: ulcerative colitis

Control

Analysing the diversity of the fungal and bacterial in patients without ulcerative colitis. We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.

Other: Control

Interventions

ulcerative colitisOTHER

We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.

Also known as: Patients With ulcerative colitis
ulcerative colitis
ControlOTHER

We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.

Also known as: Patients Without ulcerative colitis
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.

You may qualify if:

  • 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.
  • years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26843508RESULT

  • 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.

    PMID: 25522934RESULT

  • 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.

    PMID: 23882266RESULT

Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xiuli Zuo, PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD

CONTACT

15588818685zuoxiuli@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy director of the physician

Study Record Dates

First Submitted

December 19, 2016

First Posted

May 12, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)