MedTrace Logo

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

NCT03259659 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-07-31

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Jiande Chen, PhD · Johns Hopkins University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03259659 on ClinicalTrials.gov