Clinical trial NCT03259659: Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Official title: Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: irritable bowel disease patients and healthy controls.

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.


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.

Primary outcomes:
measure: symptoms characteristics in ulcerative colitis patients
timeFrame: 1 day
Secondary outcomes:
measure: autonomic profile characteristics in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: inflammatory cytokine profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
measure: microbiota profile in ulcerative colitis patients and healthy controls
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jiande Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: