TEA for Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Michigan, Ann Arbor, MI
Constipation-predominant Irritable Bowel Syndrome (IBS-C)+3 More
TEA - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

Eligible Conditions

  • Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Daily for 14 weeks

Daily for 14 weeks
Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS)
Daily Stool Diary - Change in abdominal bloating
Daily Stool Diary - Change in number of bowel movements
Daily Stool Diary - Change sense of urgency
Week 14
Change in Bowel Habits Per Separate IBS-SSS Survey
Change in IBS - Symptom Severity Score (IBS-SSS)
Weekly for 14 weeks
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Change in Hospital Anxiety and Depression Scale (HADS) - Depression
Change in global abdominal pain
Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

TEA at location A
1 of 4
TEA at location C
1 of 4
Escitalopram treatment
1 of 4
TEA at location B
1 of 4
Experimental Treatment
Non-Treatment Group

160 Total Participants · 4 Treatment Groups

Primary Treatment: TEA · Has Placebo Group · Phase 2 & 3

TEA at location A
Device
Experimental Group · 1 Intervention: TEA · Intervention Types: Device
TEA at location C
Device
Experimental Group · 1 Intervention: TEA · Intervention Types: Device
Escitalopram treatment
Drug
Experimental Group · 1 Intervention: Lexapro · Intervention Types: Drug
TEA at location B
Device
ShamComparator Group · 1 Intervention: TEA · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEA
2017
Completed Phase 3
~370
Lexapro
2001
Completed Phase 4
~280

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: daily for 14 weeks

Trial Background

Prof. Borko Nojkov, Assistant Professor - Specialty Gastroenterology, Internal Medicine
Principal Investigator
University of Michigan
Closest Location: University of Michigan · Ann Arbor, MI
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2022First Recorded Clinical Trial
1 TrialsResearching Constipation-predominant Irritable Bowel Syndrome (IBS-C)
1003 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have ongoing and symptomatic Irritable Bowel Syndrome with constipation (IBS-C).
You are not in pain at the time of screening and the time of randomization.
You have significant abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) during the Phase-in period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References