NCT05214404

Brief Summary

Increased evidence suggests that dopamine acts as an important regulator of immune function. A substantial amount of dopamine exists in the gastrointestinal tract, especially in colonic lumen. Decreased dopamine level has been reported in the colonic mucosa of ulcerative colitis patients. Therefore, the investigators suppose that colonic dopamine could involve in the ulcerative colitis and play an important role. This study aims to explore the role of dopamine in ulcerative colitis and underlying mechanism, which will provide a rationale for diagnosis and treatment of the ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 5, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

January 5, 2022

Last Update Submit

September 23, 2022

Conditions

Keywords

DopamineUlcerative Colitis

Outcome Measures

Primary Outcomes (2)

  • Comparison of the levels of inflammatory factors in colonic mucosa

    The levels of inflammatory factors in colonic mucosa of ulcerative colitis group and non-ulcerative colitis control group were detected by Elisa to evaluate the degree of inflammation.

    1 day

  • Comparison of dopamine content in colonic mucosa

    HPLC-ECD was used to detect and compare the content of dopamine in colonic mucosa between ulcerative colitis group and non-ulcerative colitis group.

    1 day

Study Arms (2)

Ulcerative colitis group

Patients with ulcerative colitis as observation group

Other: Patients diagnosed with ulcerative colitis

Non-ulcerative colitis group

Non-ulcerative colitis as control group

Interventions

Patients with ulcerative colitis diagnosed by endoscopy and histopathology

Ulcerative colitis group

Eligibility Criteria

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

Patients with oulcerative colitis diagnosed by endoscopy and histopathology

You may qualify if:

  • Patients with or without ulcerative colitis diagnosed by endoscopy and histopathology
  • Negative bacterial culture in stool
  • Written informed consent

You may not qualify if:

  • Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system
  • Mental patients
  • Hemorrhagic diseases
  • Platelet count \< 50 × 10 \^ 9 / L
  • Allergic constitution
  • unable to tolerate or cooperate with endoscopy
  • Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endoscopic biopsy specimens of colorectal mucosa

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yan Liu, MD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 28, 2022

Study Start

February 16, 2022

Primary Completion

August 30, 2022

Study Completion

September 20, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations