Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05207618
Status:
COMPLETED
Last Update Posted:
2022-07-06
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'before- after study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)', 'timeFrame': '60 days', 'description': 'Change in IBS severity score from baseline'}, {'measure': 'Change in Stool frequency (number of deposition per day)', 'timeFrame': '60 days', 'description': 'Change in stool frequency per day from baseline'}, {'measure': 'Change in Stool consistency (Bristol stool form scale, 1-7)', 'timeFrame': '60 days', 'description': 'Change in Stool consistency from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammation', 'timeFrame': '60 days', 'description': 'serum cytokine level change from baseline. Bioplex Biorad'}, {'measure': 'Change in Intestinal permeability', 'timeFrame': '60 days', 'description': 'Change in Anti Zonuline level from baseline'}, {'measure': 'Change in Intestinal microbiota', 'timeFrame': '60 days', 'description': 'change in 16-s sequency from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intestinal microbiota', 'intestinal permeability', 'intestinal inflammation'], 'conditions': ['Irritable Bowel Syndrome', 'Diarrhea']}, 'descriptionModule': {'briefSummary': 'Irritable bowel syndrome is a highly prevalent disorder and consumes many health resources. Its physiopathogenesis is multifactorial. Some of the factors involved have to do with the alteration of the intestinal microbiota, low-grade inflammation and the alteration of intestinal permeability. Specific tannins have been shown to have prebiotic effects and could be useful in treating this condition. This is an exploratory before-after study that aims to evaluate the effect of a chestnut and quebracho extract on the symptoms of IBS diarrhea predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on metabolomics.', 'detailedDescription': 'In vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites with powerful anti-inflammatory effects such as quecetin. Irritable bowel syndrome (IBS) is a multifactorial disorder involving factors related to the intestinal microbiota, low-grade inflammation, and impaired intestinal permeability.\n\nIn this study, 30 patients with predominant IBS diarrhea and 50 healthy controls will be included. IBS patients will receive chestnut and quebracho extract twice a day for 8 weeks. They will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory cytokines and serum zonulin. Likewise, the intestinal microbiota and metabolomics will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS patients: Both sexes with a diagnosis of irritable bowel syndrome variety diarrhea according to the Rome IV criteria\n\nHealthy Controls: Relatives of patients who do not show any disease, who do not take medication or present symptoms.\n\nExclusion Criteria:\n\n* patients with digestive tract disease,\n* systemic diseases such as severe heart, kidney or liver failure,\n* history of previously known digestive tract surgeries and / or intestinal adhesions,\n* diabetes mellitus,\n* cirrhosis,\n* inflammatory bowel disease,\n* celiac disease,\n* patients with cognitive impairment,\n* alcoholics,\n* lack of consent .\n* patients who have received antibiotics in the last month.'}, 'identificationModule': {'nctId': 'NCT05207618', 'briefTitle': 'Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas José de San Martín'}, 'officialTitle': 'Utility of the Administration of Tannin Specific Natural Extract, Chesnut and Quebracho Based, for Irritable Bowel Syndrome Diarrhea Predominant', 'orgStudyIdInfo': {'id': '25130271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBS PATIENTS', 'description': 'Natural specific tannin, chestnut', 'interventionNames': ['Dietary Supplement: ARBOX (QUEBRACHO AND CHESNUT EXTRACT)']}], 'interventions': [{'name': 'ARBOX (QUEBRACHO AND CHESNUT EXTRACT)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'ARBOX TWICE A DAY FOR 60 days', 'armGroupLabels': ['IBS PATIENTS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1622', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Clinicas Jose de San Martin. Buenos Aires University', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'MARIA MARTA PISKORZ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NEUROGASTROENTEROLOGIA HOSPITAL DE CLINICAS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas José de San Martín', 'class': 'OTHER'}, 'collaborators': [{'name': 'SILVATEAM', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurogastroenterologist at Hospital de Clinicas, Principal Investigator', 'investigatorFullName': 'Maria Marta Piskorz', 'investigatorAffiliation': 'Hospital de Clinicas José de San Martín'}}}}