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Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis (TEA in SSc)

Primary Purpose

Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Acustimulation (TEA)
Sham-TEA
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients with SSc-constipation from Aim 1 of the study Patients with SCT (>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1) Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA. Exclusion Criteria -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcutaneous Electrical Acustimulation (TEA)

Sham-TEA

Arm Description

Outcomes

Primary Outcome Measures

Change in slow colonic transit (SCT)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion

Secondary Outcome Measures

Change in rectal hyposensitivity as assessed by the anorectal manometry
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),

Full Information

First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05989763
Brief Title
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Acronym
TEA in SSc
Official Title
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
August 14, 2028 (Anticipated)
Study Completion Date
September 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder, Autonomic Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Electrical Acustimulation (TEA)
Arm Type
Experimental
Arm Title
Sham-TEA
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Acustimulation (TEA)
Intervention Description
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Intervention Type
Device
Intervention Name(s)
Sham-TEA
Intervention Description
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Primary Outcome Measure Information:
Title
Change in slow colonic transit (SCT)
Description
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
Time Frame
baseline, week 4 (visit 2)
Secondary Outcome Measure Information:
Title
Change in rectal hyposensitivity as assessed by the anorectal manometry
Time Frame
baseline, week 4 (visit 2)
Title
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Time Frame
baseline, week 4 (visit 2)
Title
Change in autonomic dysfunction as assessed by the COMPASS-31 measures
Description
This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction
Time Frame
baseline, week 4 (visit 2)
Title
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
Time Frame
baseline, week 4 (visit 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients with SSc-constipation from Aim 1 of the study Patients with SCT (>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1) Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA. Exclusion Criteria -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zsuzsanna H McMahan, MD, MHS (M-PI)
Phone
7135007531
Email
Zsuzsanna.H.McMahan@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sharvari R Kamat
Phone
713-500-6898
Email
Sharvari.R.Kamat@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsuzsanna H McMahan, MD, MHS (M-PI)
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsuzsanna H McMahan, MD, MHS (M-PI)
Phone
713-500-6883
Email
Zsuzsanna.H.McMahan@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sharvari R Kamat
Phone
713-500-6898
Email
Sharvari.R.Kamat@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

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