Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06738420
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Faecal calprotectin', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'change in faecal calprotectin levels (mg/g)'}, {'measure': 'faecal lactoferrin', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'change in the number of participants with a positive "faecal lactoferrin" result (%)'}, {'measure': 'Blood IgAs', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'levels of serum IgAs (mg/dL)'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal symptoms', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'assessment of number of diarrhea, vomits and regurgitation events'}, {'measure': 'faecal consisitency', 'timeFrame': 'from baseline to day 14 of supplementation', 'description': 'assessed through Bristol scale (1-7 score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diarrhoea', 'postbiotic', 'adults'], 'conditions': ['Diarrhoea of Diverse Aetiology Requiring Oral Rehydration Therapy', 'Diarrhoea and Gastrointestinal Symptoms Secondary to Enteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '40126284', 'type': 'DERIVED', 'citation': 'Mateus Rodriguez JA, Rodriguez Sanz P, Kostandyan E, Palacios Sanchez R, Pino Roque ML, Chaves Vasquez P, Roy Millan P. Mitigating Diarrhoea-Related Inflammation in Frail Older Adults with Postbiotic-Enhanced Oral Rehydration Solution: Insights from a Randomised, Double-Blind, Placebo-Controlled Study. Geriatrics (Basel). 2025 Mar 1;10(2):34. doi: 10.3390/geriatrics10020034.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients of the centre\n\n * Diagnostic of diarrhoea: increase in daily faecal weight \\> 200 g (as per the Centre protocol).\n * Subjects who as per the Centre protocol require Oral rehydration therapy\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\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 in situation of last days\n * Amytriptilin and masalazine treatment (anti-depressives)\n * Laxatives'}, 'identificationModule': {'nctId': 'NCT06738420', 'acronym': 'ABB S3/ABB C22', 'briefTitle': 'Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Biotek'}, 'officialTitle': 'Efficacy and Tolerability of a Nutritional Supplementation With Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial', 'orgStudyIdInfo': {'id': '2022-003423-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABB S3 - active', 'description': 'Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition', 'interventionNames': ['Dietary Supplement: ABB S3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ABB S3 - Placebo', 'description': 'Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABB C22 - active', 'description': 'Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration', 'interventionNames': ['Dietary Supplement: ABB C22']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ABB C22 - placebo', 'description': 'Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'ABB S3', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition', 'armGroupLabels': ['ABB S3 - active']}, {'name': 'ABB C22', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration', 'armGroupLabels': ['ABB C22 - active']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition', 'armGroupLabels': ['ABB S3 - Placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration', 'armGroupLabels': ['ABB C22 - placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': "0803'", 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Isabel Roig', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'According to legislation', 'ipdSharing': 'YES', 'description': 'Biomarkers data (calprotectin, lactoferrin, igA) data, Bristol scale data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Biotek', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Colisée Barcelona Isabel Roig', 'class': 'UNKNOWN'}, {'name': 'Grupo Colisée', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}