Inflammatory Bowel DiseasesNCT03259659
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
An observational study of Inflammatory Bowel Diseases, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 29 Feb 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: irritable bowel disease patients and healthy controls.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
- 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
- Inflammatory Bowel Diseases
- Being tested
- ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity indexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (29)
autonomic profile characteristics in ulcerative colitis patients and healthy controls
heart rate variability indicating sympathetic and parasympathetic activity
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Granulocyte-colony stimulating factor (G-CSF)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Eotaxin
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -1α
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Leptin
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Macrophage Inflammatory Proteins (MIP) -1α
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -4
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -1β
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -2
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -6
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Epidermal growth factor (EGF)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -13
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -10
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -12p70
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Interferon gamma (IFNγ)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -5
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -17A
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, interleukin (IL) -18
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Interferon - induced protein 10 (IP-10),
Measured: 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
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Vascular endothelial growth factor (VEGF)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Fractalkine
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Macrophage Inflammatory Proteins (MIP) -2
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, Tumor necrosis factor (TNF) α
Measured: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)
Measured: 1 day
microbiota profile in ulcerative colitis patients and healthy controls
fecal sample microbiota analysis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start30 Nov 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Why it stopped: Principal Investigator was leaving the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiande Chen, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259659
- Sponsor's protocol ID
- IRB00095405
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2017
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
- ClinicalTrials.gov ID
- NCT03259659
- Acronym / sponsor ID
- IRB00095405
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator was leaving the institution.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irritable bowel disease patient | – | Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity indexPatients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index. |
| healthy control | – | Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity indexHealthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- irritable bowel disease patients and healthy controls.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity indexIn 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. | Other | healthy control, irritable bowel disease patient |
Primary outcome
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.
29 secondary outcomes
autonomic profile characteristics in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
inflammatory cytokine profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
microbiota profile in ulcerative colitis patients and healthy controls
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Principal Investigator was leaving the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiande Chen, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator was leaving the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms characteristics in ulcerative colitis patients (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.