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 would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

irritable bowel disease patients and healthy controls.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
healthy control; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jiande Chen, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Inflammatory Bowel Diseases; Proctitis
• Other Study ID Numbers: IRB00095405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No