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Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

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Johns Hopkins University

Status

Terminated

Conditions

Inflammatory Bowel Diseases

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT03259659
IRB00095405

Details and patient eligibility

About

  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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

irritable bowel disease patient
Description:
Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.
Treatment:
Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
healthy control
Description:
Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.
Treatment:
Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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