Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Overview

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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 29, 2020

Interventions

  • Other: ECG 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • symptoms characteristics in ulcerative colitis patients
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jiande Chen, PhD, Principal Investigator, Johns Hopkins University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.