Effect and Mechanism of Dopamine on Ulcerative Colitis

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Dopamine Dysregulation Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • The Fifth Medical Center of Chinese PLA General Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with oulcerative colitis diagnosed by endoscopy and histopathology

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, MD, Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Dopamine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Dopamine-UC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No