Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT02311868
Status:
UNKNOWN
Last Update Posted:
2014-12-09
First Post:
2014-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in plasma p-cresol concentration', 'timeFrame': '30 days', 'description': 'Fasting blood samples were drawn for the p-cresol plasma level'}], 'secondaryOutcomes': [{'measure': 'composite outcome of gastrointestinal symptoms', 'timeFrame': '30 days', 'description': 'Patients were asked to fill in a form for the scored evaluation of gastrointestinal symptoms (upper and inferior abdominal pain, borborygmus and flatus defecation frequency or easeand stool), and stool shape (Bristol stool chart)'}]}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'descriptionModule': {'briefSummary': 'The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in hemodialysis patients. In the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in hemodialysis patients.', 'detailedDescription': 'In patients with end stage renal disease, alterations in gut microbioma are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that has been associated to cardiovascular mortality.\n\nThis double blind randomized placebo controlled pilot study evaluates whether Probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in hemodialysis patients.\n\nThirty patients on hemodialysis were randomized to receive either Probinul neutro® or placebo for four weeks. Total plasma p-cresol concentrations was assessed at baseline, and 15 and 30 days after treatment start. At the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were quantified by subjective assessment questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodialysis\n* age \\>18 years\n\nExclusion Criteria:\n\n* severe infections\n* diabetes\n* malignancy\n* history of food intolerance\n* autoimmune disorders\n* severe malnutrition\n* clinical conditions requiring artificial feeding\n* kidney transplant'}, 'identificationModule': {'nctId': 'NCT02311868', 'briefTitle': 'Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'orgStudyIdInfo': {'id': 'P-cres Probinul'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SYNBIOTIC', 'description': 'Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 day', 'interventionNames': ['Dietary Supplement: SYNBIOTIC (Probinul neutro®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients of this group received 5g of placebo 3 times a day for 30 days', 'interventionNames': ['Dietary Supplement: PLACEBO']}], 'interventions': [{'name': 'SYNBIOTIC (Probinul neutro®)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PROBINUL'], 'description': 'Probinul neutro® assumed three times a day far from meals as 5 g powder packets dissolved in water. Probinul neutro® contains 5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarus and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus termophilus, prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.', 'armGroupLabels': ['SYNBIOTIC']}, {'name': 'PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tapioca-resistant starch powder similar in colour, texture and taste to the symbiotic mixture, assumed three times a day far from meals as 5 g powder packets dissolved in water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'eleonora riccio, md', 'role': 'CONTACT', 'email': 'elyriccio@libero.it', 'phone': '3396770124'}], 'facility': 'federico II university, department of nephrology', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'eleonora riccio', 'role': 'CONTACT', 'email': 'elyriccio@libero.it', 'phone': '3396770124'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Eleonora Riccio', 'investigatorAffiliation': 'Federico II University'}}}}