Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06738433
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota composition', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).'}], 'secondaryOutcomes': [{'measure': 'Transit time', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'transit time measured as methane on breathe testing'}, {'measure': 'Tolerance and gastro-intestinal comfort', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'Tolerance and gastro-intestinal comfort (validated questionnaires) life questionnaire: the Digestion-associated Quality of Life Questionnaire (DQLQ)'}, {'measure': 'Brain Derived Neurotrophic Factor (BDNF)', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'levels of Brain Derived Neurotrophic Factor (BDNF) (pg/mL)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constipation', 'prebiotic', 'postbiotic', 'gastrointestinal', 'dietary supplement'], 'conditions': ['Constipation']}, 'referencesModule': {'references': [{'pmid': '40780410', 'type': 'DERIVED', 'citation': 'Culqui Levano DR, Rodriguez Sanz P, Palacios Sanchez R, Saldana Miranda MY, Santa Cruz Lopez CY, Mateus Rodriguez JA. Impact of prebiotics and postbiotics in the management of constipation: Analysis of their differentiated modulation of intestinal microbiota. Clin Nutr ESPEN. 2025 Oct;69:625-633. doi: 10.1016/j.clnesp.2025.08.003. Epub 2025 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who require hospitalization\n* Constipation defined as the Rome IV criteria for constipation\n* Patients with the ability to take the study product orally\n\nExclusion Criteria:\n\n* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.\n* History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations\n* Patients last palliative care en stage of "end of life" or "terminal"\n* Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment\n* Laxatives\n* Antibiotic treatment in the previous 2 weeks\n* Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation'}, 'identificationModule': {'nctId': 'NCT06738433', 'acronym': 'ABB i5/ABB C24', 'briefTitle': 'Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Biotek'}, 'officialTitle': 'Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial', 'orgStudyIdInfo': {'id': 'ABB i5/ABB C24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABB i5', 'description': 'Prebiotic ABB i5 (NextDext®, 5g)', 'interventionNames': ['Dietary Supplement: ABB i5']}, {'type': 'EXPERIMENTAL', 'label': 'ABB C24', 'description': 'ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g', 'interventionNames': ['Dietary Supplement: ABB C24']}], 'interventions': [{'name': 'ABB i5', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Prebiotic ABB i5 (NextDext®, 5g)', 'armGroupLabels': ['ABB i5']}, {'name': 'ABB C24', 'type': 'DIETARY_SUPPLEMENT', 'description': 'ABB C24: Prebiotic ABB i5 (NextDext®, 5g) + yeast postbiotic ABB C22 (200 mg) in sachets containing 5,2 g', 'armGroupLabels': ['ABB C24']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08030', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'South Sudan', 'facility': 'Isabel Roig'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'According to legislation', 'ipdSharing': 'YES', 'description': 'Statistical results on microbiological data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Biotek', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Grupo Colisée', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}