Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease

Официальное название

Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are: * Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation? * Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status? Researchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes. Participants will: * Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation * Participate in follow-up sessions with the dietitian for 3 months * Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality

Вмешательства

• Поведенческое Dietitian-Guided Nutritional Intervention
  Participants receive a diet plan and nutritional counseling provided by a registered dietitian, based on a standardized protocol aligned with the Dietary Reference Intakes (DRIs) and adapted for the management of Parkinson's disease and constipation. The intervention includes follow-ups with the dietitian over a 3-month period.

Первичные конечные точки

• Change in weekly bowel movement frequency [Срок оценки: Baseline and 90 days]

Вторичные конечные точки (1)

• Change in relative abundance of gut microbial taxa [Срок оценки: Baseline and 90 days]

Критерии участия

Критерии включения

• Adults with a previous diagnosis of Parkinson's disease
• On a stable dose of levodopa for at least 3 months
• Diagnosis of Functional Constipation by the Rome IV protocol

Критерии исключения

• Diagnosis of atypical or secondary parkinsonism
• Hoehn and Yahr stage greater than 2
• Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures
• Previous diagnosis of dementia
• Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and/or chronic kidney disease
• History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract
• Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus
• Use of opioids
• Use of probiotics or antibiotics in the past 8 weeks
• Continuous use of laxatives in the past 8 weeks
• Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)
• Individuals receiving enteral or parenteral nutrition
• Individuals under nutritional follow-up in the past 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital de Clínicas de Porto Alegre (HCPA) — Porto Alegre

Публикации

• National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Committee on the Dietary Reference Intakes for Energy. Dietary Reference Intakes for Energy. Washington (DC): National Academies Press (US); 2023 Jan 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK588659/ PMID 36693139
• Barichella M, Cereda E, Cassani E, Pinelli G, Iorio L, Ferri V, Privitera G, Pasqua M, Valentino A, Monajemi F, Caronni S, Lignola C, Pusani C, Bolliri C, Faierman SA, Lubisco A, Frazzitta G, Petroni ML, Pezzoli G. Dietary habits and neurological features of Parkinson's disease patients: Implications for practice. Clin Nutr. 2017 Aug;36(4):1054-1061. doi: 10.1016/j.clnu.2016.06.020. Epub 2016 Jul PMID 27406858
• Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available. PMID 27147121
• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424. PMID 26474316
• Brendler JH, da Silva KY, Dall'Alba V, Martins AF, Teixeira-Dos-Santos D, Schuh AFS, Olchik MR. Dietitian-led intervention to manage constipation in Parkinson's disease: Study protocol for a parallel-group randomized controlled trial (NUTRI-GUT-PD). PLoS One. 2026 Jul 27;21(7):e0354608. doi: 10.1371/journal.pone.0354608. eCollection 2026. PMID 42507749

Идентификаторы

NCT: NCT07213856 · 2025-0374

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗