Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease (NCT07213856) | Clinical Trial Compass
RecruitingNot Applicable
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Brazil54 participantsStarted 2026-04-02
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically looking at whether a nutritional intervention can improve bowel movement frequency in Parkinson's disease, can you help me understand how my current constipation compares to what they're measuring — and whether that makes this worth exploring for me?
2This study is listed as Phase NA, which often means it's testing a dietary or nutritional approach rather than a drug — can you explain what that might mean for how much is already known about the safety and effectiveness of this particular intervention?
3Are there standard dietary changes, fiber supplements, or medications you'd already recommend for constipation in Parkinson's that I should try first, or alongside considering this trial?
4What would participating in this trial actually look like day-to-day — are there special foods, supplements, or dietary restrictions involved, and is that realistic given everything else I'm managing with my Parkinson's treatment?
5Could joining this trial affect any of my current Parkinson's medications or therapies in any way I should be aware of before deciding whether to discuss enrollment with my care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.