Parkinson's Disease and Digestive Health

NCT ID: NCT04032262

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2021-12-30

Brief Summary

This study focuses on the relationship between the brain and the gut, and additionally will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Detailed Description

Parkinson's disease affects 1 million people in the US with a rising prevalence. In addition to neurological problems, patients with Parkinson's Disease often suffer from debilitating gastrointestinal (GI) symptoms related to delayed stomach emptying, gas/bloating, and constipation. GI complaints of patients suffering from Parkinson's Disease are poorly understood. This proposal aims to characterize GI disturbance in patients with Parkinson's Disease and provide deeper understanding by investigating symptoms, regional and whole gut transit, anorectal physiology, and the brain-gut axis. The investigator believes patients with Parkinson's Disease will show altered GI sensation, slower GI motility and demonstrate deranged regulation of the brain-gut axis correlated to severity of Parkinson's disease. Results from this study of GI motility and brain-gut axis will define a subset of Parkinson's Disease patients that can benefit from tailored treatment. This study will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Conditions

Parkinson Disease; Constipation; Gastro-Intestinal Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease Relationship to the GI track

Patients with Parkinson's.

Group Type: OTHER

Gastrointestinal and Parkinson's Disease

Intervention Type: DIAGNOSTIC_TEST

Subjects with Parkinson's disease will come for visits that will contain questionnaires about their PD, their bowel movements, and do further tests using anal rectal probes to understand further their constipation, and other tests to gather data on their digestion.

Interventions

Gastrointestinal and Parkinson's Disease

Subjects with Parkinson's disease will come for visits that will contain questionnaires about their PD, their bowel movements, and do further tests using anal rectal probes to understand further their constipation, and other tests to gather data on their digestion.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Presence of 2 of 3 cardinal features of PD (resting tremor, bradykinesia, and rigidity)
• Hoehn and Yahr Scale stage I-IV
• Men or women aged 18+
• Stable dopaminergic treatment for ≥4 weeks.
• Women of childbearing potential must agree to a urine pregnancy test at screening and to avoid pregnancy throughout the study.

Exclusion Criteria

• Secondary parkinsonism.
• Parkinson-plus syndromes.
• Montreal Cognitive Assessment score <17.
• Unstable dosage of drugs active in the cns (e.g., anxiolytics, antidepressants) during the 60 days before the visit.
• Participation in drug studies within 30 days of screening.
• Structural brain disease.
• Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
• Active or personal history of epilepsy.
• Acute illness or active, confounding medical, neurologic, or musculoskeletal conditions.
• Alcoholism or other forms of drug addiction.
• Significant prior gastrointestinal surgery.
• Ongoing chemotherapy or other treatment for cancer.
• Dysphagia
• implanted or externally worn medical device such as, but not limited to, a pacemaker. (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parkinson's Disease Foundation

OTHER

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University Digestive Health Research

Augusta, Georgia, United States

Countries

United States

Other Identifiers

PARKIDF00001

Identifier Type: -

Identifier Source: org_study_id