TerminatedNCT03259659Updated Jul 31, 2020

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

An observational study in Inflammatory Bowel Diseases, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-31.

Sponsored by Johns Hopkins University · Observational

Why this study was terminated

Principal Investigator was leaving the institution.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 20
Ages: 18 Years to 65 Years
Sex: All

Study summary

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.

Conditions studied

Inflammatory Bowel Diseases

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

irritable bowel disease patients and healthy controls.

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

Exclusion Criteria:

None.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 20 participants (actual)
Target follow-up: 1 Day
Patient registry: Yes
Biospecimen retention: Samples with dna

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.
Other: 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.
Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

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.

What researchers measure

Primary outcomes

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.
Time frame: 1 day

Secondary outcomes

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

Study locations

1 site

Johns Hopkins University
Baltimore, Maryland 21224, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03259659
Lead sponsor: Johns Hopkins University
Responsible party: Sponsor
First posted: Aug 24, 2017
Start date: Nov 30, 2017
Primary completion: Feb 29, 2020
Completion: Feb 29, 2020
Last update: Jul 31, 2020

Study contacts

Jiande Chen, PhD

principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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