What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome (IBS) include Transcutaneous Electrical Acupoint Stimulation (TEA) and Selective Serotonin Reuptake Inhibitors (SSRIs) like Escitalopram. TEA, which involves electrical stimulation of acupoints, is generally well-tolerated but may cause mild skin irritation or discomfort at the site of stimulation. SSRIs, such as Escitalopram, can have side effects including nausea, headache, sleep disturbances, sexual dysfunction, and increased anxiety initially. Both treatments aim to modulate pain perception and improve symptoms, but patients should discuss potential side effects with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS) that align with the mechanisms of Transcutaneous Electrical Acupoint Stimulation (TEA) and Escitalopram. For neuromodulation, devices like the transcutaneous electrical nerve stimulation (TENS) have been explored, although specific FDA approvals for IBS are limited. Regarding SSRIs, medications such as Escitalopram (Lexapro) have been used off-label to manage IBS symptoms by modulating serotonin levels, which can help alleviate pain and improve gastrointestinal function. These treatments aim to address the pain and discomfort associated with IBS through different mechanisms of action.

What other types of research exist?

Promising novel alternatives for IBS treatment in 2024 include: 1) Acupuncture and electroacupuncture, which have shown benefits in managing gastrointestinal symptoms and pain. 2) Low-dose antidepressants like amitriptyline and venlafaxine, which have been effective in functional gastrointestinal disorders. 3) Prokinetics added to proton pump inhibitors, which have shown efficacy in gastroesophageal reflux disease and may benefit IBS patients with motility issues. 4) Complementary therapies such as progressive muscle relaxation and guided imagery, which have been effective in managing symptoms and improving quality of life in related conditions.

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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

Summary

This trial tests TEA and escitalopram on people with IBS-C to see if they can reduce abdominal pain. TEA uses electrical currents on the skin, and escitalopram boosts serotonin in the brain.

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.

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.

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 ~ weekly for 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly for 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey

Change in global abdominal pain

Secondary study objectives

Cathartics

Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety

Change in Hospital Anxiety and Depression Scale (HADS) - Depression

+6 more

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

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

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

Do I qualify?Apply below to find out

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.