Inflammatory Bowel Diseases
Conditions
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.
Interventions
OTHERECG 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
Johns Hopkins University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptoms characteristics in ulcerative colitis patients | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| autonomic profile characteristics in ulcerative colitis patients and healthy controls | 1 day | heart rate variability indicating sympathetic and parasympathetic activity |
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | 1 day | blood sample, Granulocyte-colony stimulating factor (G-CSF) |
| microbiota profile in ulcerative colitis patients and healthy controls | 1 day | fecal sample microbiota analysis |
Countries
United States
Outcome results
None listed