Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Study Overview
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Brief Summary
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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.

Official Title
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Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| irritable bowel disease patient<br>Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index. | Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index<br>* 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.<br>|
| healthy control<br>Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index. | Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms characteristics in ulcerative colitis patients | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomic profile characteristics in ulcerative colitis patients and healthy controls | heart rate variability indicating sympathetic and parasympathetic activity | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Granulocyte-colony stimulating factor (G-CSF) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Eotaxin | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -1α | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Leptin | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Macrophage Inflammatory Proteins (MIP) -1α | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -4 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -1β | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -2 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -6 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Epidermal growth factor (EGF) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -13 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -10 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -12p70 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Interferon gamma (IFNγ) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -5 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -17A | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, interleukin (IL) -18 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Monocyte Chemoattractant Protein-1 (MCP-1) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Interferon - induced protein 10 (IP-10), | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, growth regulated oncogene (GRO)/Keratinocyte chemoattractant KC/cytokine-induced neutrophil chemoattractant (CINC)-1 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Vascular endothelial growth factor (VEGF) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Fractalkine | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Lipopolysaccharide-induced CXC chemokine (LIX) | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Macrophage Inflammatory Proteins (MIP) -2 | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, Tumor necrosis factor (TNF) α | 1 day | 
| inflammatory cytokine profile in ulcerative colitis patients and healthy controls | blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted) | 1 day | 
| microbiota profile in ulcerative colitis patients and healthy controls | fecal sample microbiota analysis | 1 day |