Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Inflammatory Bowel Diseases Clinical Trial

Official title:

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03259659
• Other study ID #: IRB00095405
• Status: Terminated
• Start date: November 30, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: September 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Proctitis

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	autonomic profile characteristics in ulcerative colitis patients and healthy controls	heart rate variability indicating sympathetic and parasympathetic activity	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Granulocyte-colony stimulating factor (G-CSF)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Eotaxin	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -1a	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Leptin	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Macrophage Inflammatory Proteins (MIP) -1a	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -4	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -1ß	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -2	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -6	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Epidermal growth factor (EGF)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -13	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -10	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -12p70	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Interferon gamma (IFN?)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -5	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -17A	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, interleukin (IL) -18	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Interferon - induced protein 10 (IP-10),	1 day
Secondary	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
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Vascular endothelial growth factor (VEGF)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Fractalkine	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Macrophage Inflammatory Proteins (MIP) -2	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, Tumor necrosis factor (TNF) a	1 day
Secondary	inflammatory cytokine profile in ulcerative colitis patients and healthy controls	blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)	1 day
Secondary	microbiota profile in ulcerative colitis patients and healthy controls	fecal sample microbiota analysis	1 day