Dietitian-Led Nutritional Program to Improve Constipation in Adults with Parkinsons Disease
Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-06-16
54
Participants Needed
1
Research Sites
113 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether a dietitian-guided nutritional intervention can improve constipation symptoms in adults with Parkinsons disease PD who have functional constipation. This study aims to determine if this tailored diet plan can increase weekly bowel movements and positively affect gut microbiota, dietary intake, and nutritional status compared to a control group receiving general dietary guidance after the study. The trial focuses on these important questions to better manage bowel function issues in people with PD.
Participants in the intervention group will receive a diet plan created by a registered dietitian based on Dietary Reference Intakes and adapted to the needs of individuals with PD and constipation. They will have follow-up sessions with the dietitian over a 3-month period. The control group will not receive individualized nutritional support during the study but will get general dietary guidance after the 3-month study period. The study uses a randomized, parallel design to compare these groups.
During the study, participants will complete assessments at the start, midpoint, and end to evaluate bowel function, constipation symptoms, gut microbiota composition, nutritional status, and diet quality. The main outcome measured is the change in weekly bowel movement frequency from baseline to 90 days. Secondary outcomes include changes in gut microbial taxa. The study will monitor participants over the 3-month intervention period, with safety and adherence overseen by the research team.
CONDITIONS
Brief Title
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Research Team
M
Maira Rozenfeld Olchik, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
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
You will not qualify if you...
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Nutritional Intervention
Duration - 3 months
Participants receive a personalized diet plan and counseling from a registered dietitian, with follow-up sessions over 3 months to manage constipation symptoms.
Follow-up sessions during the 3-month intervention
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Phase 3 Randomized Study of Bemdaneprocel Cell Therapy Compared to Sham Surgery in Adults Aged 45 to 75 with Parkinsons Disease
Study of Biological Factors and Brain Compensation in Swallowing Problems in Parkinsons Disease
Effects of Daily Intake of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation A Randomized Crossover Study
Comparing Directional Deep Brain Stimulation of Posterior Subthalamic Area and Subthalamic Nucleus
for Tremor-Dominant Parkinsons Disease in a Randomized Double-Blind Crossover Trial
Accelerating Clinical Trials for Parkinsons Disease Using Multiple Treatments Including Telmisartan and Terazosin Compared to Placebo
Study of Lactulose Alone and With Probiotics on Gut Health and Constipation in Adults With Type 2 Diabetes
Gamma-glutamylcysteine Supplementation to Boost Brain Glutathione and Improve Motor and Cognitive Function in Early Parkinsons Disease Patients Aged 50 to 80
Improving Upper Limb Function in Parkinsons Disease Using Exergaming with Physical Objects
A Randomized Study Comparing Phygital Therapy and Conventional Physical Therapy
Understanding and Improving Sacral Neuromodulation Treatment in Children with Gastrointestinal Motility Disorders
Advanced Brain Imaging to Study Parkinsons Disease Using MRI
Identifying New Brain Networks for Targeted Treatments
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Dietitian-led intervention to manage constipation in Parkinson's disease: Study protocol for a parallel-group randomized controlled trial (NUTRI-GUT-PD).
Juliana Heitich Brendler, Khadija Younes da Silva, Valesca Dall'Alba...