NCT06381921 Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain
| NCT ID | NCT06381921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Connecticut |
| Condition | Abdominal Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-09-08 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial.
Eligibility Criteria
Inclusion Criteria: * Participants need to be diagnosed with IBS by a healthcare provider according to Rome-III or -IV criteria, with a current report of abdominal pain. * Men and women 18-50 years old * Able to read and speak English * Daily access to a computer with internet access. Exclusion Criteria: * Other chronic pains that are usually not comorbid with IBS, e.g., diabetic neuropathy, myofascial pain, low back pain, peripheral neuropathy etc. * Celiac disease or inflammatory bowel disease * Diabetes mellitus; d) Serious mental health conditions * Women during pregnancy or within 3 months post-partum period * Self- reported Regular use of opioids or other illicit substances. * Participants who have had COVID-19 should be fully recovered, and will be asked if their medical provider has made any restriction on activities.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06381921 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Abdominal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06381921 currently recruiting?
Yes, NCT06381921 is actively recruiting participants. Contact the research team at hugo.posada-quintero@uconn.edu for enrollment information.
Where is the NCT06381921 trial being conducted?
This trial is being conducted at Storrs, United States.
Who is sponsoring the NCT06381921 clinical trial?
NCT06381921 is sponsored by University of Connecticut. The trial plans to enroll 120 participants.