Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT07213856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-09
First Post:
2025-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-10-02', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in dietary intake', 'timeFrame': 'Baseline, 45 days and 90 days', 'description': 'Variation in intake of macronutrients and fiber, assessed through 24h food records.'}], 'primaryOutcomes': [{'measure': 'Change in weekly bowel movement frequency', 'timeFrame': 'Baseline and 90 days', 'description': 'Mean change in the number of spontaneous bowel movements per week from baseline to 12 weeks, based on participant-reported bowel diaries.'}], 'secondaryOutcomes': [{'measure': 'Change in relative abundance of gut microbial taxa', 'timeFrame': 'Baseline and 90 days', 'description': "Change in the relative abundance of selected bacterial genera associated with constipation and Parkinson's disease, measured by 16S rRNA sequencing of stool samples."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiota', 'Diet', 'Diet, Protein-Restricted', 'Diet Therapy', 'Diet, Healthy', 'Nutrition Therapy', 'Constipation', 'Non-Motor Symptoms', 'Nutritionists'], 'conditions': ['Parkinsons Disease (PD)', 'Constipation - Functional']}, 'referencesModule': {'references': [{'pmid': '36693139', 'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '27406858', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '27147121', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26474316', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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:\n\n* Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?\n* Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?\n\nResearchers 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.\n\nParticipants will:\n\n* Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation\n* Participate in follow-up sessions with the dietitian for 3 months\n* Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults with a previous diagnosis of Parkinson's disease\n* On a stable dose of levodopa for at least 3 months\n* Diagnosis of Functional Constipation by the Rome IV protocol\n\nExclusion Criteria:\n\n* Diagnosis of atypical or secondary parkinsonism\n* Hoehn and Yahr stage greater than 2\n* Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures\n* Previous diagnosis of dementia\n* Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and/or chronic kidney disease\n* History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract\n* Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus\n* Use of opioids\n* Use of probiotics or antibiotics in the past 8 weeks\n* Continuous use of laxatives in the past 8 weeks\n* Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)\n* Individuals receiving enteral or parenteral nutrition\n* Individuals under nutritional follow-up in the past 3 months"}, 'identificationModule': {'nctId': 'NCT07213856', 'acronym': 'NUTRI-GUT-PD', 'briefTitle': "Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': "Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial", 'orgStudyIdInfo': {'id': '2025-0374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Intervention Group', 'description': "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.", 'interventionNames': ['Behavioral: Dietitian-Guided Nutritional Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': 'Dietitian-Guided Nutritional Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Diet plan'], 'description': "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.", 'armGroupLabels': ['Nutritional Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'contacts': [{'name': 'Maira Rozenfeld Olchik, PhD', 'role': 'CONTACT', 'email': 'molchik@hcpa.edu.br', 'phone': '+55 (51) 33083020'}, {'name': 'Juliana Heitich Brendler, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre (HCPA)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Maira Rozenfeld Olchik, PhD', 'role': 'CONTACT', 'email': 'molchik@hcpa.edu.br', 'phone': '+55 (51) 33083020'}], 'overallOfficials': [{'name': 'Maira Rozenfeld Olchik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}