Effect and Mechanism of Dopamine on Ulcerative Colitis

NCT ID: NCT05214404

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-16

Study Completion Date

2022-09-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dopamine Dysregulation Syndrome Ulcerative Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative colitis group

Patients with ulcerative colitis as observation group

Patients diagnosed with ulcerative colitis

Intervention Type OTHER

Patients with ulcerative colitis diagnosed by endoscopy and histopathology

Non-ulcerative colitis group

Non-ulcerative colitis as control group

No interventions assigned to this group

Interventions

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Patients diagnosed with ulcerative colitis

Patients with ulcerative colitis diagnosed by endoscopy and histopathology

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

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The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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Dopamine-UC

Identifier Type: -

Identifier Source: org_study_id

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