ClinicalTrials.gg
RecruitingNCT07213856NUTRI-GUT-PDUpdated Jun 16, 2026

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

An interventional study of Dietitian-Guided Nutritional Intervention in Parkinsons Disease (PD) and Constipation - Functional, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Parkinsons Disease (PD)
  • Constipation - Functional

Keywords

  • Microbiota
  • Diet
  • Diet, Protein-Restricted
  • Diet Therapy
  • Diet, Healthy
  • Nutrition Therapy
  • Constipation
  • Non-Motor Symptoms
  • Nutritionists
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 54 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Nutritional Intervention Group

    Participants will receive a tailored diet plan made by a registered dietitian, with follow-ups for 3 months. The plan is based on Dietary Reference Intakes and adapted to Parkinson's disease and constipation management guidelines.

    Behavioral: Dietitian-Guided Nutritional Intervention

  • No intervention
    Control Group

    Participants will not receive individualized nutritional support during the study period. They will receive the dietary guidance only after the end of the study (3 months).

Interventions

  • BehavioralDietitian-Guided Nutritional Intervention

    Participants receive a diet plan and nutritional counseling provided by a registered dietitian, based on a standardized protocol aligned with the Dietary Reference Intakes (DRIs) and adapted for the management of Parkinson's disease and constipation. The intervention includes follow-ups with the dietitian over a 3-month period.

    Also known as: Diet plan

06

What researchers measure

Primary outcomes

  1. Change in weekly bowel movement frequency

    Mean change in the number of spontaneous bowel movements per week from baseline to 12 weeks, based on participant-reported bowel diaries.

    Time frame: Baseline and 90 days

Secondary outcomes

  1. Change in relative abundance of gut microbial taxa

    Change in the relative abundance of selected bacterial genera associated with constipation and Parkinson's disease, measured by 16S rRNA sequencing of stool samples.

    Time frame: Baseline and 90 days

Other outcomes

  1. Change in dietary intake

    Variation in intake of macronutrients and fiber, assessed through 24h food records.

    Time frame: Baseline, 45 days and 90 days

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre (HCPA)
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
    • Maira Rozenfeld Olchik, PhD · Contactmolchik@hcpa.edu.br · +55 (51) 33083020
    • Juliana Heitich Brendler, Msc · Sub investigator
08

References and documents

Publications

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Committee on the Dietary Reference Intakes for Energy. Dietary Reference Intakes for Energy. Washington (DC): National Academies Press (US); 2023 Jan 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK588659/ PubMed 36693139 ↗
  • Barichella M, Cereda E, Cassani E, Pinelli G, Iorio L, Ferri V, Privitera G, Pasqua M, Valentino A, Monajemi F, Caronni S, Lignola C, Pusani C, Bolliri C, Faierman SA, Lubisco A, Frazzitta G, Petroni ML, Pezzoli G. Dietary habits and neurological features of Parkinson's disease patients: Implications for practice. Clin Nutr. 2017 Aug;36(4):1054-1061. doi: 10.1016/j.clnu.2016.06.020. Epub 2016 Jul 5. PubMed 27406858 ↗
  • Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available. PubMed 27147121 ↗
  • Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424. PubMed 26474316 ↗
  • Brendler JH, da Silva KY, Dall'Alba V, Martins AF, Teixeira-Dos-Santos D, Schuh AFS, Olchik MR. Dietitian-led intervention to manage constipation in Parkinson's disease: Study protocol for a parallel-group randomized controlled trial (NUTRI-GUT-PD). PLoS One. 2026 Jul 27;21(7):e0354608. doi: 10.1371/journal.pone.0354608. eCollection 2026. PubMed 42507749 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jun 2027, 14 months after the start.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 14 months is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2025
First posted
Oct 9, 2025
StartActual
Apr 2, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Aug 2029
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07213856
Responsible party
Sponsor
First posted
Oct 9, 2025
Start date
Apr 2, 2026
Primary completion
Jun 2027 (estimated)
Completion
Aug 2029 (estimated)
Last update
Jun 16, 2026

Study contacts

Maira Rozenfeld Olchik, PhD
Contact
molchik@hcpa.edu.br
+55 (51) 33083020
Maira Rozenfeld Olchik, PhD
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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