NCT07213856 Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
| NCT ID | NCT07213856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Parkinsons Disease (PD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2026-04-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Maira Rozenfeld Olchik, PhD
PRINCIPAL INVESTIGATOR
Federal University of Rio Grande do Sul
Frequently Asked Questions
Who can join the NCT07213856 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinsons Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213856 currently recruiting?
Yes, NCT07213856 is actively recruiting participants. Contact the research team at molchik@hcpa.edu.br for enrollment information.
Where is the NCT07213856 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT07213856 clinical trial?
NCT07213856 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Maira Rozenfeld Olchik, PhD at Federal University of Rio Grande do Sul. The trial plans to enroll 54 participants.
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