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Recruiting
NCT05622721
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Conditions: Dysbiosis, Clostridium Difficile, Pet-Human Bonding, Antibiotic-Associated Colitis
Sex: All
Ages: 50 Years – N/A
Enrollment: 200
Sponsor: University of Pennsylvania
Location: United States
Summary
Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly.
Drawing on observations that pet ownership and close contact with pets are protective against colonization with C. difficile and recurrence of C. difficile infection, the proposed study will test the hypothesis that microbiota that provide colonization resistance against C. difficile are shared between patients and their pets and that pet contact can mitigate antimicrobial-associated gut dysbiosis and the risk of C. difficile infection.
This study will further define epidemiologic and pathophysiologic characteristics of C. difficile infection and gut microbiome dysbiosis that could enhance therapeutic options for these conditions, potentially through non-invasive interventions involving animal contact.
Eligibility Criteria
Inclusion Criteria:50 years of age or older.Receiving a dental implant.Ability to understand study procedures and to comply with them for the entire length of the study.Exclusion Criteria:Antimicrobial therapy or hospitalization in the prior three months;Any gastrointestinal illness or underlying pathology (e.g., Inflammatory Bowel Disease, gastric ulceration)Sustained diarrheal disease (i.e., at least 3 episodes of loose or watery stool per day for 3 or more days) in the prior 3 months;Prior history of CDI in the prior year;Immunomodulating medication (e.g., tumor necrosis factor inhibitors or systemic steroids) or conditions (e.g., leukemia)Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Source: ClinicalTrials.gov (NCT05622721). StuddyBuddy aggregates publicly available trial information.