RECRUITING

Home Transcutaneous Electrical Acustimulation (TEA)

Conditions

Irritable Bowel Syndrome With Constipation Constipation Irritable Bowel Syndrome Colon, Irritable Irritable Colon

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.

Official Title

Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)

Quick Facts

Study Start:2022-11-02

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05519683

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Colin Burnett

CONTACT

734-647-2806

bucolin@med.umich.edu

Principal Investigator

Borko Nojkov, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Borko Nojkov, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-02

Study Completion Date2025-09

Study Record Updates

Study Start Date2022-11-02

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Irritable Bowel Syndrome with Constipation
Constipation
Irritable Bowel Syndrome
Colon, Irritable
Irritable Colon

Additional Relevant MeSH Terms

Irritable Bowel Syndrome With Constipation