TerminatedInterventionalNot ApplicableUpdated Mar 22, 2022
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis | NCT03259659 | Trialant
TerminatedObservationalUpdated Jul 31, 2020
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
ClinicalTrials.gov ID
NCT03259659
Lead Sponsor
Johns Hopkins UniversityOTHER
Overall Status
Terminated
Study Type
Observational
Enrollment
20Actual
Last Update Posted
Jul 31, 2020Actual
Start Date
Nov 30, 2017Actual
Primary Completion Date
Feb 29, 2020Actual
Completion Date
Feb 29, 2020Actual
Official Title
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Brief Summary
To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.
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.
Inflammatory Bowel Diseases
ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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;