Variable Compression System for moderate to severe IBS

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 is a prospective interventional pilot of a wearable Variable Compression System (VCS) for adults with moderate to severe irritable bowel syndrome. The study plans to enroll 20 participants who must wear the VCS device for at least six hours each day. Participants will be seen at baseline and followed at 21 days, 8 weeks, and 6 months to monitor safety and symptom change. The trial aims to gather preliminary data on tolerability and effectiveness to inform larger studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent to participate in the trial as prescribed.
* Subjects with a weight of ≥50 kg and a body mass index between 18 and 40 kg/m2.
* Diagnosed with IBS(C)-constipation, IBS(D)-diarrhea, or IBS(M)-mixed patients' diagnosis according to Rome Criteria (moderate to severe).

Exclusion Criteria:

* Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator.
* Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or psychiatric disorders making implementation of the protocol or interpretation of the trial results difficult, or that would put the participant at risk by participating in the trial in the opinion of the Investigator.
* Hospital admission or major surgery within 30 days prior to screening.
* Pregnant, or positive urine pregnancy test.
* Participation in any other investigational drug trial within 30 days prior to screening.
* Participant with substance use disorder (SUD) and/or alcohol use disorder (AUD).
* Participant who has other conditions that may affect compliance in the opinion of the investigator, or who are unable to participate in the trial on his/her own.
* Participant with end stage organ disease.

Where it's running

• Central Florida Gastro Research
  Kissimmee, Florida, United States Recruiting
• UChicago Medicine AdventHealth Medical Group Gastroenterology at Bolingbrook
  Bolingbrook, Illinois, United States Recruiting
• Delta Gastroenterology PC
  Southhaven, Mississippi, United States Recruiting

Study contacts

• Study coordinator: Agim Beshiri, MD
• Email: agim.beshiri@cmoproconsult.com
• Phone: +12623448468

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gut microbiome in post-infectious irritable bowel syndrome

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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.