Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05336305
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2022-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polydextrose for Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C033375', 'term': 'polydextrose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-03-06', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change constipation status after supplementation with polydextrose', 'timeFrame': '2 months', 'description': 'Stool frequency and Bristol Stool Form'}, {'measure': 'Change in cytokines plasma levels measured by ELISA after supplementation with polydextrose', 'timeFrame': '2 months', 'description': 'cytokines levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Constipation']}, 'referencesModule': {'references': [{'pmid': '37321430', 'type': 'DERIVED', 'citation': 'Borges NA, Sahiun E, Ribeiro-Alves M, Regis B, Mafra D. Effects of Polydextrose Supplementation on Intestinal Function in Hemodialysis Patients: A Double-Blind, Randomized, Placebo-Controlled Trial. J Ren Nutr. 2023 Nov;33(6):747-754. doi: 10.1053/j.jrn.2023.06.008. Epub 2023 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Chronic Kidney Disease\n* Hemodialysis patients for more than 6 months\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Patients pregnant\n* Smokers\n* Using antibiotics in the last 3 months\n* Autoimmune diseases\n* Clinical diagnosis of infectious diseases\n* Clinical diagnosis of Cancer\n* Clinical diagnosis of AIDS'}, 'identificationModule': {'nctId': 'NCT05336305', 'briefTitle': 'Polydextrose for Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal Fluminense'}, 'officialTitle': 'Effects of Polydextrose Supplementation on Constipation in Patients Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'DeniseMafra15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Administration of corn starch daily for 2 months', 'interventionNames': ['Dietary Supplement: Polydextrose']}, {'type': 'EXPERIMENTAL', 'label': 'polydextrose', 'description': 'Administration of 12g polydextrose daily for 2 months', 'interventionNames': ['Dietary Supplement: Polydextrose']}], 'interventions': [{'name': 'Polydextrose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of 3g polydextrose per day, for 2 months', 'armGroupLabels': ['Placebo Group', 'polydextrose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22260050', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Denise Mafra', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal Fluminense', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Denise Mafra', 'investigatorAffiliation': 'Universidade Federal Fluminense'}}}}