Effect and Mechanism of Dopamine on Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Effect and Mechanism of Dopamine on Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214404
• Other study ID #: Dopamine-UC
• Status: Completed
• Start date: February 16, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: September 2022
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Dopamine Dysregulation Syndrome
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
China	The Fifth Medical Center of Chinese PLA General Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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