TEA + Lexapro for Irritable Bowel Syndrome

(Home-TEA Trial)

Overseen By Colin Burnett

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Michigan

Must not be taking: SSRIs, SNRIs, Antipsychotics, NSAIDs

Disqualifiers: Pregnancy, Diabetes, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, TEA and Lexapro, to evaluate their effectiveness in relieving abdominal pain in individuals with Irritable Bowel Syndrome with Constipation (IBS-C). TEA delivers a gentle electrical pulse similar to acupuncture, while Lexapro is a medication commonly used for IBS. Participants will receive one of these treatments or a sham treatment for comparison. Ideal candidates experience ongoing IBS-C symptoms, including frequent abdominal pain not relieved by current treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes those using specific drugs like SSRIs, SNRIs, and other serotonin-active medications, as well as some other medications like antipsychotics and frequent NSAID users. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Transcutaneous Electrical Acustimulation (TEA) is generally safe for treating symptoms like constipation and stomach pain. Studies have found that TEA speeds up bowel movements and reduces discomfort without causing serious side effects. Users often report feeling better both physically and mentally.

Lexapro (escitalopram), commonly used for mood disorders, is also considered safe for treating irritable bowel syndrome (IBS). However, it can sometimes cause side effects like diarrhea or bloating. Many people tolerate it well, and it helps with pain by affecting communication between the brain and gut.

Both treatments have undergone testing, and results suggest they are well-tolerated by most people. However, as with any treatment, individual reactions may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for irritable bowel syndrome (IBS) because they offer innovative approaches beyond the typical options like dietary changes, fiber supplements, and medications such as antispasmodics or antidepressants. TEA (Transcutaneous Electrical Acupoint stimulation) is distinctive because it uses mild electrical stimulation through the skin, similar to acupuncture, which provides a non-invasive alternative to traditional drug therapies. Meanwhile, Lexapro (escitalopram) is being tested for IBS due to its neuromodulatory effects, potentially improving symptoms by influencing serotonin levels, which is different from its usual use for depression and anxiety. These treatments could offer new hope for IBS patients by providing relief through unique mechanisms and delivery methods.

What evidence suggests that this trial's treatments could be effective for irritable bowel syndrome?

Research has shown that Transcutaneous Electrical Acustimulation (TEA), which participants in this trial may receive, can alleviate symptoms of Irritable Bowel Syndrome (IBS). Studies have found that TEA eases stomach pain and relieves constipation by accelerating colon function, with benefits lasting up to six months. Meanwhile, escitalopram, another treatment option in this trial, reduced stomach pain related to anxiety in IBS patients and proved more effective than a placebo in managing mental health symptoms linked to IBS. Together, these treatments offer hope for improving IBS symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Borko Nojkov, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have ongoing and symptomatic IBS with constipation.

I have severe abdominal pain, as measured on a pain scale.

My abdominal pain is not well-managed currently.

Exclusion Criteria

Known allergy to adhesive Electrocardiogram (ECG) electrodes

Any other condition which in the opinion of the investigator would impede compliance or hinder the completion of the study

I do not have active conditions like IBD, diabetes, or thyroid issues causing abdominal pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TEA or escitalopram treatment for abdominal pain in IBS-C

8 weeks

Home-based treatment, twice daily

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Weekly surveys and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Lexapro
• TEA

Trial Overview

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.

How Is the Trial Designed?

Group I: TEA at location C Experimental Treatment 1 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 A Experimental Treatment 1 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 treatment Experimental Treatment 1 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 B Placebo Group 1 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.

Lexapro is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder

Approved in European Union as Escitalopram for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder
• Obsessive-compulsive disorder
• Panic disorder with or without agoraphobia

Approved in Canada as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Transcutaneous electrical acustimulation (TEA) significantly improved constipation and abdominal pain in patients with irritable bowel syndrome with constipation (IBS-C), with an increase in complete spontaneous bowel movements per week (3.5 vs 2.3) and a reduction in pain scores after 4 weeks of treatment.

TEA enhanced colonic transit and rectal sensation thresholds, likely through increased vagal activity, suggesting a potential mechanism for its effectiveness in treating IBS-C symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Improves Irritable Bowel Syndrome With Constipation by Accelerating Colon Transit and Reducing Rectal Sensation Using Autonomic Mechanisms. Huang, Z., Lin, Z., Lin, C., et al.[2022]

Cisapride significantly enhances small bowel motor activity in both constipation-predominant and diarrhoea-predominant irritable bowel syndrome patients, as well as in healthy subjects, indicating its potential efficacy in improving gastrointestinal motility.

The effects of cisapride are particularly pronounced in diarrhoea-predominant patients, where it increases both the motility index and the proportion of propagated contractions, suggesting a tailored approach may be beneficial for different IBS subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral cisapride on small bowel motility in irritable bowel syndrome. Evans, PR., Bak, YT., Kellow, JE.[2019]

Escitalopram is a highly effective and well-tolerated treatment for moderate-to-severe major depressive disorder (MDD), showing consistent superiority over citalopram based on pooled clinical trial data.

Preliminary studies indicate that escitalopram's efficacy is comparable to other SSRIs and venlafaxine, with potential cost-effectiveness benefits, making it a strong first-line treatment option for MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on escitalopram in the management of major depressive disorder. Murdoch, D., Keam, SJ.[2022]

In a study involving 67 patients with diarrhea-predominant irritable bowel syndrome (IBS-D), mirtazapine was found to be significantly more effective than placebo in reducing the severity of IBS symptoms, with a notable improvement in quality of life and anxiety levels.

Mirtazapine was well-tolerated by patients, showing significant improvements in various IBS-related symptoms, except for bloating, indicating its potential as a beneficial treatment option for IBS-D, especially for those with psychological symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to assess efficacy of mirtazapine for the treatment of diarrhea predominant irritable bowel syndrome. Khalilian, A., Ahmadimoghaddam, D., Saki, S., et al.[2021]

Transcutaneous electrical acustimulation (TEA) significantly improved dyspeptic symptoms and gastric accommodation in 30 patients with postprandial distress syndrome compared to a sham treatment, indicating its potential efficacy as a noninvasive therapy.

TEA treatment was associated with increased vagal activity and reduced levels of IL-6 in the duodenal mucosa, suggesting that its therapeutic effects may involve modulation of neuroimmune mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture Enhances Gastric Accommodation via the Autonomic and Cytokine Mechanisms in Functional Dyspepsia. Chen, X., Chen, X., Chen, B., et al.[2023]

A meta-analysis of seven randomized controlled trials found that tricyclic antidepressants (TCAs) significantly improve symptoms of irritable bowel syndrome (IBS), with a relative risk of clinical improvement of 1.93.

TCAs, including amitriptyline and imipramine, showed a substantial reduction in abdominal pain scores, indicating that low doses of these medications can effectively manage IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tricyclic antidepressants in irritable bowel syndrome: a meta-analysis. Rahimi, R., Nikfar, S., Rezaie, A., et al.[2022]

Transcutaneous electrical acustimulation (TEAS) at specific acupoints (ST36 and P6) significantly increased the threshold for rectal sensations such as gas, the desire to defecate, and pain in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Despite the reduction in rectal sensitivity, TEAS did not significantly change rectal tone or compliance, indicating that the mechanism of action may not involve alterations in rectal biomechanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical acustimulation can reduce visceral perception in patients with the irritable bowel syndrome: a pilot study. Xing, J., Larive, B., Mekhail, N., et al.[2022]

In an 8-week open-label trial involving 5,453 outpatients with major depressive disorder, escitalopram demonstrated a robust response rate of 68% based on clinician assessments, indicating its efficacy in a real-world setting.

The treatment was well tolerated, with only 9% of patients discontinuing due to adverse events, suggesting that escitalopram is a safe option for managing depression in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram in clinical practice: results of an open-label trial in a naturalistic setting. Rush, AJ., Bose, A.[2022]

Escitalopram oxalate is an effective antidepressant that has shown robust efficacy in treating major depressive disorder and anxiety disorders, with significant improvements observed compared to placebo in multiple clinical trials.

The medication has a favorable safety profile, with a low rate of discontinuation due to adverse events, and the most common side effects, such as nausea and insomnia, were generally mild, affecting less than 10% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram. Burke, WJ.[2022]

Transcutaneous electrical acustimulation (TEA) significantly reduced the incidence of stroke-induced constipation in ischemic stroke patients, decreasing it from 68.2% to 42.9% over a 2-week period.

TEA improved bowel movement frequency and consistency, while also enhancing patients' quality of life, likely by balancing autonomic function, as it increased vagal activity and decreased sympathetic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive effects of transcutaneous electrical acustimulation on ischemic stroke-induced constipation mediated via the autonomic pathway. Liu, Z., Ge, Y., Xu, F., et al.[2019]

Current therapies for Irritable Bowel Syndrome (IBS), including traditional treatments like antidepressants and fiber supplements, as well as alternative therapies like peppermint oil and herbal supplements, lack sufficient evidence to support their effectiveness.

The review highlights that no IBS treatments can be reliably recommended due to inadequate high-quality studies demonstrating their efficacy, emphasizing the need for better-designed clinical trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional therapies for irritable bowel syndrome: an evidence-based appraisal. Fennerty, MB.[2005]

The study demonstrated that the Chinese formulation of escitalopram oxalate 20 mg tablets is bioequivalent to the reference formulation (Lexapro®), as shown by pharmacokinetic parameters meeting bioequivalence criteria in 24 healthy subjects.

No serious adverse events occurred during the study, indicating that both formulations are well-tolerated and safe for use in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions. Li, Q., Huo, H., Hu, W., et al.[2022]

In a study of 150 patients with anxiety or depression, 75.3% believed that a orodispersible (ODT) formulation of escitalopram might work faster than traditional tablets, indicating a positive attitude towards this delivery method.

The majority of patients (80.7%) found the ODT packaging easy to use, and 96% enjoyed the pleasant taste of the placebo ODT, suggesting high acceptability for this formulation among those who have difficulty swallowing tablets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of patient preferences for a placebo orodispersible tablet. Wade, AG., Crawford, GM., Young, D.[2021]

Escitalopram was found to be a safe and effective treatment for functional gastrointestinal disorders (FGIDs) in a study of 51 patients, showing significant improvements in IBS severity, GERD symptoms, and throat discomfort after treatment.

Despite its efficacy, 80% of patients experienced mild side effects, and many refused or discontinued the medication due to fears about psychiatric treatments, highlighting the need to address compliance issues for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, and barriers to use escitalopram in functional gastrointestinal disorders. Alkhowaiter, SS., Alshahrani, AH., Almarzouqi, HF., et al.[2023]

Patients with recurrent bowel movement disorders often experience symptoms without serious underlying conditions, and serious disorders are not more common than in the general population unless accompanied by other symptoms.

Among treatments, antispasmodics like pinaverium and peppermint oil show the best efficacy with moderate side effects, while tricyclic antidepressants and SSRIs have limited benefits and frequent adverse effects, suggesting a cautious approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome: a mild disorder; purely symptomatic treatment. [2022]

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IBS and Lexapro: What to Expect From Treatment

Experts think that Lexapro and other antidepressants can help IBS symptoms by modifying pain messages that pass between the brain and the gut.