Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259659
Recruitment Status : Terminated (Principal Investigator was leaving the institution.)
First Posted : August 24, 2017
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. autonomic profile characteristics in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    heart rate variability indicating sympathetic and parasympathetic activity

  2. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Granulocyte-colony stimulating factor (G-CSF)

  3. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Eotaxin

  4. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)

  5. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -1α

  6. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Leptin

  7. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Macrophage Inflammatory Proteins (MIP) -1α

  8. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -4

  9. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -1β

  10. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -2

  11. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -6

  12. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Epidermal growth factor (EGF)

  13. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -13

  14. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -10

  15. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -12p70

  16. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Interferon gamma (IFNγ)

  17. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -5

  18. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -17A

  19. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, interleukin (IL) -18

  20. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)

  21. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Interferon - induced protein 10 (IP-10),

  22. 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

  23. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Vascular endothelial growth factor (VEGF)

  24. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Fractalkine

  25. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)

  26. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Macrophage Inflammatory Proteins (MIP) -2

  27. inflammatory cytokine profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    blood sample, Tumor necrosis factor (TNF) α

  28. 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)

  29. microbiota profile in ulcerative colitis patients and healthy controls [ Time Frame: 1 day ]
    fecal sample microbiota analysis


Biospecimen Retention:   Samples With DNA
blood sample for inflammatory cytokines, fecal sample for microbiota


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
irritable bowel disease patients and healthy controls.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259659


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Jiande Chen, PhD Johns Hopkins University
Additional Information:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03259659    
Other Study ID Numbers: IRB00095405
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammatory Bowel Diseases
Proctitis
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Rectal Diseases