Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

July 29, 2020 updated by: Johns Hopkins University
  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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
autonomic profile characteristics in ulcerative colitis patients and healthy controls
Time Frame: 1 day
heart rate variability indicating sympathetic and parasympathetic activity
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Granulocyte-colony stimulating factor (G-CSF)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Eotaxin
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -1α
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Leptin
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Macrophage Inflammatory Proteins (MIP) -1α
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -4
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -1β
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -2
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -6
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Epidermal growth factor (EGF)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -13
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -10
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -12p70
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Interferon gamma (IFNγ)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -5
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -17A
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, interleukin (IL) -18
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Interferon - induced protein 10 (IP-10),
1 day
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
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Vascular endothelial growth factor (VEGF)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Fractalkine
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Macrophage Inflammatory Proteins (MIP) -2
1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
blood sample, Tumor necrosis factor (TNF) α
1 day
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)
1 day
microbiota profile in ulcerative colitis patients and healthy controls
Time Frame: 1 day
fecal sample microbiota analysis
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiande Chen, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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