A Phase 2/3 interventional study of TEA and Lexapro in Irritable Bowel Syndrome With Constipation, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Michigan · Phase 2/3, Interventional, and Treatment
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.
The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the participants will be divided into 4 treatment groups designed to investigate the feasibility of TEA using optimized parameters in comparison with medical neuromodulation therapy (escitalopram) and sham-TEA. The treatment will be home-based and last for a period of 8 weeks. To preserve scientific integrity and effective masking, certain details of arms and interventions will be made more precise upon or prior to reporting results
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 160 is above the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: TEA
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.
Device: TEA
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.
Device: TEA
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.
Drug: Lexapro
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. 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.
Also known as: Transcutaneous Electrical Acustimulation
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.
Also known as: escitalopram
Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.
Time frame: Daily for 14 weeks
Change in global abdominal pain
Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied). These answers will be compared from week 1 to week 14.
Time frame: Weekly for 14 weeks
Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey
A self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment. This survey is 34 questions, all scored from 1 to 5, with 1 being the lowest (not at all) and 5 being the highest (a great deal, or extremely). The individual responses to the 34 items are summed and averaged for a total score. These answers will be compared from week 0 to week 14
Time frame: Weekly for 14 weeks
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Determines levels of anxiety that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14
Time frame: Weekly for 14 weeks
Change in Hospital Anxiety and Depression Scale (HADS) - Depression
Determines levels of depression that a person is experiencing by asking 7 questions scored from 0-3, with 0 being the lowest (not at all) and 3 being the highest (most of the time). Responses for each category will be totaled and compared against the below ranges. 0-7 = normal 8-10 = borderline abnormal 11-21 = abnormal Scores will be compared from week 0 to week 14
Time frame: Weekly for 14 weeks
Change in IBS - Symptom Severity Score (IBS-SSS)
A survey designed to record and monitor the severity of IBS. The maximum achievable score was 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively. Scores will be compared from day 10 to day 90
Time frame: Once every 10 days for 14 weeks
Daily Stool Diary - Change in number of bowel movements
The Daily Stool Diary will ask how many bowel movements have occurred in the past 24 hours. This will also ask to indicate the number of spontaneous bowel movements (a bowel movement which occurs without use of rescue medications or maneuvers) and number of complete spontaneous bowel movements (a bowel movement which is associated with a feeling of complete evacuation) The change in the mean daily number of bowel movements will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.
Time frame: Daily for 14 weeks
Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS)
The Daily Stool Diary will use the BSFS to evaluate the stool consistency for each of the bowel movements in the past 24 hours. The BSFS is scored from 1 to 7, which are defined as follows: BSFS Type 1: Separate hard lumps, like nuts BSFS Type 2: Sausage-shaped but lumpy BSFS Type 3: Like a sausage but with cracks on its surface BSFS Type 4: Like a sausage or snake, smooth and soft BSFS Type 5: Soft blobs with clear-cut edges BSFS Type 6: Fluffy pieces with ragged edges, a mushy stool BSFS Type 7: watery, no solid pieces, entirely liquid The change in the mean daily scores for Bristol Stool Form Scale will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.
Time frame: Daily for 14 weeks
Daily Stool Diary - Change in abdominal bloating
The Daily Stool Diary will rate the severity of participants abdominal bloating over past 24 hours on a visual analog scale for bloating (0-10 scale), with 0 being the lowest (no bloating) and 10 being the highest (worst imaginable bloating) The change in the mean daily scores for abdominal bloating will be averaged over 1 week and compared between the phase-in period and the final week of the treatment period.
Time frame: Daily for 14 weeks
Daily Stool Diary - Change sense of urgency
The Daily Stool Diary will assess the sense of urgency with the following question: "Have you felt or experienced a sense of urgency today?" which will be answered with a yes or no. The change in the most frequent daily scores for sense of urgency will be calculated over 1 week and compared between the phase-in period and the final week of the treatment period.
Time frame: Daily for 14 weeks
Change in Bowel Habits Per Separate IBS-SSS Survey
This survey (a part of the IBS-SSS which is not factored into the scoring) contains 9 questions asking about bowel habits. This will question the minimum and maximum number of bowel movements per day/week/month, typical location of pain, the effect of IBS pain on work habits. Responses will be compared from day 10 to day 90
Time frame: Once every 10 days for 14 weeks
Plan to share: No — De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared
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Studies of the drug tested here: Escitalopram