Ulcerative ColitisNCT03151850
The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Xiuli Zuo at 1 site in China.
Trial summary
We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ulcerative colitis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, PhD, 15588818685 ext. 053188369277, zuoxiuli@sina.com
Lidong Xu, MD
About this study
Official title: The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification
We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- ulcerative colitis, Control
- Keywords
- fungal, mucosa, diversity, Basidiomycete
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulcerative colitisOther
Also called Patients With ulcerative colitis
We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.
ControlOther
Also called Patients Without ulcerative colitis
We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
yeasts detection rate
Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuli Zuo
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor-investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151850
- Sponsor's protocol ID
- 2015SDU-QILU-G004
- Status last verified
- May 2017
- First submitted
- 19 Dec 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26843508Mukhopadhya 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.
PubMed 25522934Eriksson 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.
PubMed 23882266Shang Y, Wang X, Diao X, Li L, Zuo X. The Degree of Mucosa-Associated Microecological Imbalance in Ulcerative Colitis Patients with Different Mayo Score and Its Relationship with Mucosal Mechanical Barrier Damage. Turk J Gastroenterol. 2025 Oct 9;37(1):26-34. doi: 10.5152/tjg.2025.24609.
PubMed 41578770
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification
- ClinicalTrials.gov ID
- NCT03151850
- Acronym / sponsor ID
- 2015SDU-QILU-G004
- Conditions
- Ulcerative Colitis
- Keywords
- fungal, mucosa, diversity, Basidiomycete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiuli ZuoUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ulcerative colitis | – | Other: ulcerative colitisWe 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. |
| Control | – | Other: ControlAnalysing 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulcerative colitisAlso: Patients With ulcerative colitisWe take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing. | Other | ulcerative colitis |
| ControlAlso: Patients Without ulcerative colitisWe take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing. | Other | Control |
Primary outcome
fungus detection rate
Time frame: 6 months
Fungi detection rate was defined as the percentage of patients in whose colonic mucosa at least one kind of fungus were identified.
yeasts detection rate
Time frame: 6 months
Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.
candida albicans detection rate
Time frame: 6 months
Candida albicans detection rate was defined as the percentage of patients in whose colonic mucosa candida albicans were identified.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Results publication: PubMed 26843508Sokol 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.
- Results publication: PubMed 25522934Mukhopadhya 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.
- Results publication: PubMed 23882266Eriksson 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.
- Derived from this study: PubMed 41578770Shang Y, Wang X, Diao X, Li L, Zuo X. The Degree of Mucosa-Associated Microecological Imbalance in Ulcerative Colitis Patients with Different Mayo Score and Its Relationship with Mucosal Mechanical Barrier Damage. Turk J Gastroenterol. 2025 Oct 9;37(1):26-34. doi: 10.5152/tjg.2025.24609.
- PUBmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zuo, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Xiuli Zuo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, PhD (15588818685 ext. 053188369277, zuoxiuli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fungus detection rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151850, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.