Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Constipation Clinical Trial

— TEA in SSc  

Official title:

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05989763
• Other study ID #: HSC-MS-23-0531
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: September 1, 2029

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Zsuzsanna H McMahan, MD, MHS (M-PI)
• Phone: 7135007531
• Email: Zsuzsanna.H.McMahan[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2029
• Est. primary completion date: August 14, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Constipation
• Gastrointestinal Motility Disorder
• Primary Dysautonomias
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Device:
• Transcutaneous Electrical Acustimulation (TEA)
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
• Sham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, week 4 (visit 2)
Secondary	Change in rectal hyposensitivity as assessed by the anorectal manometry		baseline, week 4 (visit 2)
Secondary	Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures		baseline, week 4 (visit 2)
Secondary	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	baseline, week 4 (visit 2)
Secondary	Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),		baseline, week 4 (visit 2)