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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 14 weeks
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily for 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily 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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Irritable Bowel Syndrome (IBS) include Transcutaneous Electrical Acupoint Stimulation (TEA) and Selective Serotonin Reuptake Inhibitors (SSRIs) like Escitalopram. TEA works by electrically stimulating specific acupoints to modulate the nervous system and increase endorphin release, which helps alleviate pain.
Escitalopram increases serotonin levels in the brain and gut, aiding in pain modulation and mood improvement. These treatments are significant for IBS patients as they address both the physical and psychological aspects of the condition, offering a comprehensive approach to managing symptoms.
How Serotonin Level Fluctuation Affects the Effectiveness of Treatment in Irritable Bowel Syndrome.
How Serotonin Level Fluctuation Affects the Effectiveness of Treatment in Irritable Bowel Syndrome.
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,387,202 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
790 Patients Enrolled for Irritable Bowel Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
648,017 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
837 Previous Clinical Trials
670,222 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'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.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.My abdominal pain is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: TEA at location C
- Group 2: TEA at location A
- Group 3: Escitalopram treatment
- Group 4: TEA at location B
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
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