Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

NCT ID: NCT03259659

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2020-02-29

Brief Summary

1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.

2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. Presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

irritable bowel disease patient

Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.

ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

Intervention Type: OTHER

In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.

healthy control

Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.

ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

Intervention Type: OTHER

In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.

Interventions

ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• No any systemic diseases;
• no proctitis or proctosigmoiditis;
• no history of gastrointestinal surgery;
• no symptoms of diarrhea or fecal urgency during the past 2 weeks;
• not taking any medications except contraceptives during the past 2 weeks;
• age 18-65.

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiande Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00095405

Identifier Type: -

Identifier Source: org_study_id