Effect and Mechanism of Dopamine on Ulcerative Colitis

Sponsor
Affiliated Hospital to Academy of Military Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05214404
Collaborator
(none)
60
1
2.4
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients diagnosed with ulcerative colitis

Detailed Description

This study is a case-control clinical study. 30 patients with non-ulcerative colitis examined by endoscopy were selected as the control group. According to the inclusion and exclusion criteria, 30 patients with ulcerative colitis were determined. The baseline data of patients were recorded objectively: name, sex, age, vital signs, body weight and stool condition (frequency, character, etc.). Some laboratory examination results (blood routine, fecal routine and fecal culture, liver function, blood coagulation function, electrolyte, etc.), ulcerative colitis lesion range, ulcerative colitis classification and related history (common disease, treatment history and life history). Colonic mucosal tissue samples of patients with ulcerative colitis and control group were obtained by colonoscopic biopsy. The degree of inflammation was evaluated by related inflammatory factors via ELISA. The changes of dopamine system was detected by HPLC-ECD, Western Blot and immunohistochemistry. This study aims to provide new diagnostic and therapeutic basis, select appropriate drug delivery through clarify the effect and mechanism of local dopamine on colitis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect and Mechanism of Dopamine on Ulcerative Colitis
Actual Study Start Date :
Feb 16, 2022
Anticipated Primary Completion Date :
Apr 15, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Ulcerative colitis group

Patients with ulcerative colitis as observation group

Other: Patients diagnosed with ulcerative colitis
Patients with ulcerative colitis diagnosed by endoscopy and histopathology

Non-ulcerative colitis group

Non-ulcerative colitis as control group

Outcome Measures

Primary Outcome Measures

  1. Comparison of the levels of inflammatory factors in colonic mucosa [1 day]

    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.

  2. Comparison of dopamine content in colonic mucosa [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Patients with or without ulcerative colitis diagnosed by endoscopy and histopathology

  2. Negative bacterial culture in stool

  3. Written informed consent

Exclusion Criteria:
  1. Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system

  2. Mental patients

  3. Hemorrhagic diseases

  4. Platelet count < 50 × 10 ^ 9 / L

  5. Allergic constitution

  6. unable to tolerate or cooperate with endoscopy

  7. Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.

  8. Pregnant or lactating women

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Fifth Medical Center of Chinese PLA General Hosptial Beijing Beijing China 100039

Sponsors and Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT05214404
Other Study ID Numbers:
  • Dopamine-UC
First Posted:
Jan 28, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Affiliated Hospital to Academy of Military Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022