NCT07213856Recruiting
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 2 Oct 2025
- Start date
- 2 Apr 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Diseases
- Parkinson disease
- NCT number
- NCT07213856
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 2 Apr 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of dementia
- Individuals receiving enteral or parenteral nutrition
Other illness
- Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures
- 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
Other
- Diagnosis of atypical or secondary parkinsonism
- Hoehn and Yahr stage greater than 2
- 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 under nutritional follow-up in the past 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clínicas de Porto Alegre - HCPA Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.