Home treatment for abdominal pain in IBS with constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of transcutaneous electrical acustimulation (TEA) and the medication escitalopram in treating abdominal pain in patients with irritable bowel syndrome with constipation (IBS-C). Participants will be randomly assigned to one of four treatment groups, including two active treatments and a sham control, over an 8-week home-based intervention period. The study aims to compare the efficacy of electrical neuromodulation therapy against medical therapy and assess improvements in abdominal pain and other IBS symptoms. The results will help determine the feasibility and effectiveness of TEA for managing IBS-C.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
* Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period
* Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis.
* Abdominal pain is not adequately relieved at the time of screening and the time of randomization.

Exclusion Criteria:

* Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
* Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation.
* Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
* A history of abdominal surgery (other than cholecystectomy or appendectomy)
* Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (\>2 days/week) use of opioid or antispasmodic medication. Those who frequently use Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) will also be excluded.
* Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs). Individuals on chronic SSRI therapy, including escitalopram, at the initial evaluation will not be enrolled in the study.
* Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. - - Participants will be informed that MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram.
* Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations.
* Known allergy to adhesive Electrocardiogram (ECG) electrodes.
* Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts.
* Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Borko Nojkov, MD — University of Michigan
• Study coordinator: Colin Burnett
• Email: bucolin@med.umich.edu
• Phone: 734-647-2806

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.