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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Parkinsons Disease (PD)
    Constipation - Functional

NCT07213856

Hospital de Clinicas de Porto Alegre

27 June 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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