Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT06636669
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-29
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064806', 'term': 'Dysbiosis'}, {'id': 'D000084063', 'term': 'Reinfection'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multi-centered, randomized controlled trial (RCT) with two arms will be conducted at two academic, tertiary care centers.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent Prosthetic Joint Infection (PJI)', 'timeFrame': '1 year, 2 years after PJI surgery', 'description': 'The number of participants who develop PJI after PJI surgery will be abstracted from electronic medical records.'}, {'measure': 'Surgical Site Infection (SSI)', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The number of participants who develop SSI within 12 months of PJI surgery will be abstracted from electronic medical records.'}], 'secondaryOutcomes': [{'measure': 'Medical complications', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'This outcome will be assessed from information in the electronic medical records and reported as Yes or No.'}, {'measure': 'Surgical complications', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'This outcome will be assessed from information in the electronic medical records and reported as Yes or No.'}, {'measure': 'Sepsis', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The number of participants who have a diagnosis of sepsis related to PJI surgery will be abstracted from electronic medical records.'}, {'measure': 'Re-operation for recurrent infection', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The number of participants who have a re-operation for recurrent infection within 12 months of the PJI surgery will be abstracted from the electronic medical records.'}, {'measure': 'Revision surgery', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The number of participants who have revision surgery within 12 months of PJI surgery will be abstracted from electronic medical records.'}, {'measure': 'Complications related to the use of probiotics', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'This outcome will be assessed from information in the electronic medical records and reported as Yes or No.'}, {'measure': 'Mortality', 'timeFrame': '12 months post PJI surgery', 'description': 'The number of participants who die within 12 months of the PJI surgery will be abstracted from the electronic medical records.'}, {'measure': 'Patient reported health outcomes', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS)-10 score ranges from 0 to 20 points, with 0 representing the most severe impairment and 20 representing the best possible health. Low scores may indicate poorer self-reported health and a greater risk of future healthcare utilization.'}, {'measure': 'Patient reported hip disability', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'The Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) will be used to assess hip disability. It is patient reported and contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table where the interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.'}, {'measure': 'Patient reported knee disability', 'timeFrame': '3 months, 6 months, 12 months post PJI surgery', 'description': 'Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) will be used to assess knee disability. It is patient reported and contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using a table.. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Hip total joint arthroplasty (TJA)', 'Knee TJA', 'Recurrent reinfection', 'DAIR', 'Surgical site infection (SSI)', 'Patient Reported Outcome Measures (PROMs)'], 'conditions': ['Prosthetic-joint Infection', 'Dysbiosis']}, 'descriptionModule': {'briefSummary': 'Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection.\n\nDespite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.', 'detailedDescription': 'The primary and secondary aims for this RCT are:\n\nPrimary Aim 1.1 To determine the impact of administration of probiotics administered for 6 weeks after the index surgical treatment for PJI on reinfection rates (deep infection) within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).\n\nSecondary Aims 2.1 To evaluate the incidence of superficial infections including wound drainage, cellulitis, or infections superficial to the deep fascia within 1 year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).\n\n2.2 To evaluate the safety of use of probiotics in this population and to monitor the incidence of adverse events in patients administered probiotics versus standard of care in patients undergoing treatment for PJI.\n\n2.3 To evaluate the 1-year mortality rate in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).\n\n2.4 To evaluate the rate of wound healing and dehiscence in patients undergoing revision TJA for PJI in each of treatment arms (probiotics and standard of care).\n\n2.5 To evaluate the need for chronic antibiotic suppression for the treatment of PJI at final follow-up of one year following revision TJA for PJI in each of the treatment arms (probiotics and standard of care).\n\n2.6 To evaluate the rate of infection with Clostridium difficile within 90 days of finishing antibiotic therapy in each of the treatment arms (probiotics and standard of care). The risk of developing C. difficile infection is present for 90 days following cessation of antibiotic treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All patients scheduled to undergo revision total knee arthroplasty (TKA) or total hip arthroplasty (THA) for infection at the participating institutions will be screened for eligibility in this prospective trial.\n\nInclusion Criteria:\n\n* Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria\n* Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision TJA for PJI with an anticipated plan for eventual discontinuation of oral/IV antibiotics.\n* Patients with prior PJI in the same joint that has recurred.\n* Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Fungal PJI.\n* Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal\n* issue where there is concern for gut integrity.\n* History of pancreatitis at any point in time.\n* History of intolerance to probiotics.\n* Immunocompromised patients.\n* Revision TJA for aseptic reasons'}, 'identificationModule': {'nctId': 'NCT06636669', 'briefTitle': 'Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'The Role of Peri-operative Adjunctive Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee', 'orgStudyIdInfo': {'id': 'H-44452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment- Probiotics and standard of care', 'description': 'Participants randomized into this are will receive Culturelle probiotic and standard of care.', 'interventionNames': ['Drug: Probiotic', 'Other: Standard of care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controls- Standard of care', 'description': 'Participants randomized into this are will receive standard of care.', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Probiotic', 'type': 'DRUG', 'otherNames': ['Culturelle'], 'description': 'Culturelle probiotic, one capsule daily to start following SOC surgical treatment for PJI during the initial 6 weeks of SOC antibiotic treatment.', 'armGroupLabels': ['Treatment- Probiotics and standard of care']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Standard of care (SOC) treatment includes surgery and antimicrobials.', 'armGroupLabels': ['Controls- Standard of care', 'Treatment- Probiotics and standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center, Orthopedic Surgery', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Orthopedics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ayesha Abdeen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Association of Hip and Knee Surgeons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}