Milwaukee, WINCT05212129Now EnrollingIRB Ready

Functional Gastrointestinal Disorders Clinical Trial in Milwaukee, WI

Access cutting-edge functional gastrointestinal disorders treatment through this clinical trial at a research site in Milwaukee. Study-provided care at no cost to qualified participants.

Sponsored by Medical College of Wisconsin

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Expert Care in Milwaukee

Access functional gastrointestinal disorders specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related functional gastrointestinal disorders treatment provided free

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Check if you qualify for this functional gastrointestinal disorders clinical trial in Milwaukee, WI

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Why Participate?

  • No-Cost Study Care

  • Local to Milwaukee

    Convenient for WI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Milwaukee site if eligible
  4. 4Begin participation

About This Functional Gastrointestinal Disorders Study in Milwaukee

Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.

Sponsor: Medical College of Wisconsin

Who Can Participate

Inclusion Criteria

Children aged 10-18 years old
Children with functional upper GI complaints and clinical suspicion for hEDS or HSD as well as a Beighton score of at least 4/9
Children with functional upper GI complaints and clinical suspicion for ANS dysfunction
De-identified data from our prior studies (IRB #689519 and IRB #1064187) of patients with functional GI disorders who do NOT meet criteria for hEDS will be used as a comparison group
Children who are English-speaking and lack other explanation for symptoms
Children willing to participate and consent to this study (for children, have a parent willing to participate)

Exclusion Criteria

A) Exclusion Criteria applying to all participants:
Medically complex children or those who take a medication or suffer from a disease that can explain symptoms will be excluded from participation in the study.
Adult subjects, children or their parents who have significant developmental delay (will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms)
Patients with findings of organic disease such as peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, metabolic disorder or any other chronic condition or medication that may cause chronic GI symptoms will be excluded from the study.
Patients who are treated with a new drug affecting the central nervous system in the two weeks prior to enrollment will also be excluded.
Pregnancy (evaluating MD screens patients as they normally would during a clinic visit (by questioning) and would only perform urine pregnancy test if clinically indicated (absence of menstrual period or other symptoms concerning for pregnancy)
Chronic alcohol/illicit drug use and/or smoking. B) Exclusion Criteria for subjects undergoing pVNS therapy:
Severe dermatological condition or active infection of external or middle ear
Implanted electrical device C) Exclusion Criteria for subjects undergoing aVNS therapy:
Hearing impaired
Sight impaired without correction
Seizure disorder D) Exclusion Criteria for subjects undergoing gastric motor function sub-study:
Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning
Claustrophobia or inability to lie still in the scanner
Orthodontic braces or permanent retainers
Patients who are unable to tolerate noise produced by the MRI
Egg allergy or anticipated inability to complete a standardized egg meal E) Exclusion Criteria for subjects undergoing HepGI Biobank specimen collection sub-study:
Bleeding disorder for the specific biopsies
Recent antibiotic usage for fecal sample
Significant anemia or clinical status which will not allow safe blood draw required for blood collection
Refusal of blood collection or to provide DNA sample
Inability or unwillingness on the individual (or parent/legal guardian) to provide clinical or family history.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Milwaukee?

Yes, this clinical trial (NCT05212129) has an active research site in Milwaukee, WI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Functional Gastrointestinal Disorders Treatment Options in Milwaukee, WI

If you're searching for functional gastrointestinal disorders treatment options in Milwaukee, WI, this clinical trial (NCT05212129) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Milwaukee research site is actively enrolling participants for this clinical trial. You'll receive care from experienced functional gastrointestinal disorders specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all functional gastrointestinal disorders clinical trials near you to find additional studies recruiting in your area.

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