GBPDC: Gut-Brain in PD Consortium Master Protocol

Part of paid clinical trials in Stanford, California.

Sponsor
Duke University
Study ID
NCT07567794
Status
Not Yet Recruiting

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Conditions

  • Gut Microbiome
  • Gut Microbiota
  • PARKINSON DISEASE (Disorder)
  • Parkinson Disease (PD)
  • Prodromal Parkinsons Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Accepted

Study Details

The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years).

Key Dates

Start date
Jun 4, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Household Controls
    Age-similar household controls. Household control design where controls are matched to people with PD when available.
  • Arm: People with Parkinson's disease
    The Parkinson's Disease (PD) cohort will be further classified as mild, moderate, or severe PD as classified by Hoehn and Yahr scale.
  • Arm: Prodromal Parkinson's disease
    People with Parkinson's Disease prodromal features. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.

Primary Outcome Measure

GI influences on PD [ Time Frame: enrollment to end of observation at 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Marian Shahid-Besanti, MSc
[email protected]
650-723-0060
Kathleen L Poston, MD, MS (PRINCIPAL_INVESTIGATOR)
Laren S Beckers, MD (PRINCIPAL_INVESTIGATOR)
Rush UniversityChicagoIllinois60612
Michelle Villanueva, MS
[email protected]
312-942-8927
Ali Keshavarzian, MD (PRINCIPAL_INVESTIGATOR)
Christopher Goetz, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Hanna Lancerio
[email protected]
773-633-8412
Tao Xie, MD, PhD (PRINCIPAL_INVESTIGATOR)
Eugene Chang, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Anna Borodianski
[email protected]
617-724-0480
Aleksander Videnovic, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Kelly Feuerhak, BSN, RN, CCRP
[email protected]
507-255-6802
Adil Bharucha, MBBS, MD (PRINCIPAL_INVESTIGATOR)
Rodolfo Savica, MD, PhD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10027
Katharine Godfrey
[email protected]
Braden Kuo, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Stephanie N Slan, MBA, ACRP-CP
[email protected]

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