Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-14 @ 6:54 AM
Study NCT ID:
NCT03011502
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2016-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of intensity and frequency of Diarrheic Symptoms', 'timeFrame': 'From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)', 'description': 'Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)'}], 'secondaryOutcomes': [{'measure': 'Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method', 'timeFrame': 'Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bone and Joint Infection']}, 'descriptionModule': {'briefSummary': 'Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.\n\nAs part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.\n\nMaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.\n\nTo do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.\n\nThus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled\n* The subject is willing, able to understand and comply to the protocol requirement\n* More than 18-years-old\n* Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment\n* Subject signed Inform Consent Form\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe disease with a life expectancy \\< 3 months\n* Antibiotherapy in the 14 days before inclusion in the study\n* Patient non-affiliated to health care system\n* Patient under the power of law\n* Guardianship, curators patients'}, 'identificationModule': {'nctId': 'NCT03011502', 'acronym': 'OSIRIS', 'briefTitle': 'InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS', 'organization': {'class': 'INDUSTRY', 'fullName': 'MaaT Pharma'}, 'officialTitle': 'InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS', 'orgStudyIdInfo': {'id': 'MPBJI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'interventionNames': ['Other: Biological samples collection of blood and feces']}], 'interventions': [{'name': 'Biological samples collection of blood and feces', 'type': 'OTHER', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lyon', 'country': 'France', 'facility': 'HCL Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'GH Diaconesses-Croix Saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Tourcoing', 'country': 'France', 'facility': 'CH Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Tristan Ferry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaaT Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}