Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis

Terminated

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index

• Registration Number: NCT03259659
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Study Start: 2017-11-30
• Status Verified: 2019-09
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy control	ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index	Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.
irritable bowel disease patient	ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index	Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.

Primary Outcome Measures

Name	Time	Method
symptoms characteristics in ulcerative colitis patients	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

Name	Time	Method
autonomic profile characteristics in ulcerative colitis patients and healthy controls	1 day	heart rate variability indicating sympathetic and parasympathetic activity
microbiota profile in ulcerative colitis patients and healthy controls	1 day	fecal sample microbiota analysis
inflammatory cytokine profile in ulcerative colitis patients and healthy controls	1 day	blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States