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Anti-depressant
TEA + Lexapro for Irritable Bowel Syndrome (Home-TEA Trial)
Phase 2 & 3
Recruiting
Led By Borko Nojkov, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Abdominal pain is not adequately relieved at the time of screening and the time of randomization
Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 14 weeks
Awards & highlights
Home-TEA Trial Summary
This trial will compare the effectiveness of two active treatments (TEA and escitalopram) to a sham comparator on abdominal pain.
Who is the study for?
This trial is for adults with ongoing, symptomatic Irritable Bowel Syndrome with Constipation (IBS-C) who experience abdominal pain not relieved by other treatments. Participants should have had symptoms at least once a week in the past three months and must not be pregnant or planning pregnancy. Exclusions include those with certain medical conditions, recent surgery, or using specific medications like SSRIs and NSAIDs.Check my eligibility
What is being tested?
The study tests the effectiveness of Transcutaneous Electrical Acustimulation (TEA) and Lexapro against a sham control on relieving abdominal pain in IBS-C patients. Participants will be randomly assigned to receive either TEA, Lexapro, or an inactive treatment to compare outcomes.See study design
What are the potential side effects?
Possible side effects from TEA may include skin irritation where electrodes are placed. Lexapro can cause nausea, sleepiness, weight changes, dry mouth, sexual side effects and increased sweating. It's important to note that individual reactions to treatments can vary.
Home-TEA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My abdominal pain is not well-managed currently.
Select...
I have ongoing and symptomatic IBS with constipation.
Select...
I have severe abdominal pain, as measured on a pain scale.
Home-TEA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly for 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
Change in global abdominal pain
Secondary outcome measures
Cathartics
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Change in Hospital Anxiety and Depression Scale (HADS) - Depression
+6 moreHome-TEA Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: TEA at location CExperimental Treatment1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Group II: TEA at location AExperimental Treatment1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Group III: Escitalopram treatmentExperimental Treatment1 Intervention
This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
Group IV: TEA at location BPlacebo Group1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
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
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,362 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
792 Patients Enrolled for Irritable Bowel Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,684 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
50 Patients Enrolled for Irritable Bowel Syndrome
National Center for Complementary and Integrative Health (NCCIH)NIH
829 Previous Clinical Trials
668,769 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
1,339 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active conditions like IBD, diabetes, or thyroid issues causing abdominal pain.I cannot stop taking certain medications.I have ongoing symptoms of IBS with constipation.I've had symptoms at least once a week for the last 3 months, starting 6 months before my diagnosis.I have ongoing and symptomatic IBS with constipation.I have severe abdominal pain, as measured on a pain scale.I have severe abdominal pain as measured by a specific pain scale.I have a heart condition that affects my heartbeat's timing or I am on medication that can affect my heartbeat's timing.I have had surgery in my abdomen, but it wasn't for gallbladder or appendix removal.I am currently taking SSRIs, SNRIs, serotonin medications, or tricyclic antidepressants.My abdominal pain is not well-managed currently.I am currently taking medications like painkillers, antipsychotics, or drugs for stomach issues.My abdominal pain is not well-managed currently.I've had symptoms at least once a week for the last 3 months, starting 6 months before my diagnosis.I have a history of glaucoma, bipolar disorder, seizures, or suicidal thoughts.I have ongoing and symptomatic IBS with constipation.My abdominal pain is not well-controlled.I've had symptoms at least once a week for the last 3 months, starting 6 months before my diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: Escitalopram treatment
- Group 2: TEA at location A
- Group 3: TEA at location B
- Group 4: TEA at location C
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05519683 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research open to new participants?
"According to the listing on clinicaltrials.gov, this study is no longer recruiting patients. It was first posted on November 1st, 2022 and was edited for the last time on November 7th, 2022. Even though this particular trial has completed recruitment, there are still 1547 other trials that are looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Delaware
Washington
Other
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
Why did patients apply to this trial?
No useful treatment found for IBS. I'm not sure if I have ever been put on medication for the IBS.
PatientReceived no prior treatments
I’ve tried magnesium, Miralax daily, IBSrela, all with minimal success. I’ve tried many different treatments my doctors have recommended, including surgery, without relief.
PatientReceived no prior treatments
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