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NCT03259659 · ClinicalTrials.gov registry record
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
A clinical trial, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- 20
- Enrollment target
NCT03259659: Clinical Trial study, sponsored by Johns Hopkins University.
NCT03259659 is a clinical trial that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259659 was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- 20 participants
- Enrollment target
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.
Primary Outcome
ulcerative colitis disease activity index will be assessed using the Mayo scoring system, which includes stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. The patient will get a score from 0 to 20, with higher score indicating more severe disease.
Interventions
- OTHER ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2020-02-29 |
Why NCT03259659 stopped before completion
NCT03259659 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index is the first listed.
NCT03259659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03259659 about?
NCT03259659 is a clinical study titled "Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis". 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 w...
What is the current status of trial NCT03259659?
This trial is currently terminated. The enrollment target is 20 participants. The study started on 2017-11-30. Estimated completion is 2020-02-29.
What interventions are being tested in trial NCT03259659?
The interventions under investigation include: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index (OTHER).
Who is sponsoring clinical trial NCT03259659?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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