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OpenTrials
Completed

NCT Number: NCT05214404

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Patients diagnosed with ulcerative colitis

Other

Patients with ulcerative colitis diagnosed by endoscopy and histopathology

Primary outcomes

  1. Comparison of the levels of inflammatory factors in colonic mucosa

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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