Stanford University Neurofiber Study

A vizsgálat adatai

Ki végzi

Stanford University

Azonosító

NCT07914387

A regiszteradat frissítve

2026. november 3.

Eredeti leírás

Parkinson's disease often causes constipation and changes in gut bacteria, but it is not known how quickly a daily fiber supplement changes gut physiology in people with Parkinson's, or how long any change lasts after stopping. This study will test how a daily fiber bar affects bowel function and gut inflammation in people with Parkinson's disease and in household members who live with them. Participants will eat one fiber bar (11 grams of fiber) each day for 3 months, then stop and be followed for one more month, for about 4 months in total. At three points (before starting, after 3 months of fiber, and one month after stopping), participants will collect a stool sample at home and mail it to Stanford in a provided kit, so no clinic visits are needed. Every week, participants will also fill out a short questionnaire about how often they have bowel movements, their bowel regimen, and they will complete a questionnaire about how bowel symptoms affect their daily life. In the lab, we will measure proteins in the stool that are signs of gut inflammation. We want to learn how fast these proteins change when fiber is added, whether changes last after fiber is stopped, and whether people with Parkinson's respond differently than their household partners. We expect that fiber will change gut inflammation and bowel function during the fiber period, and that these changes will differ between people with Parkinson's and their partners after the fiber bars are stopped. Results may help guide future research on diet and gut function in Parkinson's disease.A teljes eredeti leírásKevesebb

Parkinson's disease often causes constipation and changes in gut bacteria, but it is not known how quickly a daily fiber supplement changes gut physiology in people with Parkinson's, or how long any change lasts after stopping. This study will test how a daily fiber bar affects bowel function and gut inflammation in people with Parkinson's disease and in household members who live with them. Participants will eat one fiber bar (11 grams of fiber) each day for 3 months, then stop and be followed for one more month, for about 4 months in total. At three points (before starting, after 3 months of fiber, and one month after stopping), participants will collect a stool sample at home and mail it to Stanford in a provided kit, so no clinic visits are needed. Every week, participants will also fill out a short questionnaire about how often they have bowel movements, their bowel regimen, and they will complete a questionnaire about how bowel symptoms affect their daily life. In the lab, we will measure proteins in the stool that are signs of gut inflammation. We want to learn how fast these proteins change when fiber is added, whether changes last after fiber is stopped, and whether people with Parkinson's respond differently than their household partners. We expect that fiber will change gut inflammation and bowel function during the fiber period, and that these changes will differ between people with Parkinson's and their partners after the fiber bars are stopped. Results may help guide future research on diet and gut function in Parkinson's disease.

Bevonási feltételek: Diagnosed with Parkinson's disease by a movement disorders specialist; Age 18+; Lives with a participant in this study enrolled or planning to enroll in Arm 2; Not currently consuming a fiber supplement; No history of neurodegenerative disease, including Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Multiple Sclerosis; Age 18+; Lives with a participant in this study enrolled or planning to enroll in Arm 1; Not currently consuming a fiber supplement.

Kizáró feltételek: Antibiotic use in the 2 weeks before baseline; Use of probiotic supplements in the 2 weeks before baseline; Antibiotic use in the 2 weeks before baseline; Use of probiotic supplements in the 2 weeks before baseline; Allergy or intolerance to any ingredient in the study bar, including tree nuts, seeds, oats, coconut, or green tea extract; History of bowel obstruction or major gastrointestinal surgery that makes a daily fiber supplement unsafe; Celiac disease, or severe kidney or liver disease, by participant report; History of inflammatory bowel disease (IBD); Undergoing active treatment for cancer with chemotherapy or immunotherapy; Diagnosis of or current concern for dementia; Allergy or intolerance to any ingredient in the study bar, including tree nuts, seeds, oats, coconut, or green tea extract; History of bowel obstruction or major gastrointestinal surgery that makes a daily fiber supplement unsafe; Celiac disease, or severe kidney or liver disease, by participant report; History of inflammatory bowel disease (IBD); Undergoing active treatment for cancer with chemotherapy or immunotherapy; History of neurodegenerative disease, including Alzheimer's disease, Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Frontotemporal dementia, Multiple Sclerosis; Difficulty swallowing (dysphagia) that makes eating a dense, solid food bar unsafe; Pregnant or lactating (breastfeeding), by participant report; Consuming a fiber supplement; Difficulty swallowing (dysphagia) that makes eating a dense, solid food bar unsafe; Pregnant or lactating (breastfeeding), by participant report; Consuming a fiber supplement.

ClinicalTrials.gov NCT07914387