REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

NCT05622721 | Active Not Recruiting

• 2 other identifiers: 8441311K23AI163351-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysbiosis; Clostridium Difficile; Pet-Human Bonding; Antibiotic-Associated Colitis

Outcome Measures

Primary Outcomes (2)

• Longitudinal change in diversity and composition of the gut microbiota following oral antibiotic prophylaxis

  Changes in alpha diversity, beta diversity and composition of the gut microbiome will be ascertained between baseline (prior to taking antibiotics) and 3, 10, 30 and 90 days following the start of the antibiotic regimen

  90 days

• Colonization or infection with C. difficile following antibiotic prophylaxis

  The presence of C. difficile in patients' stool will be determined before and 3 days after the beginning of the antibiotic regimen

  3 days

Study Arms (2)

Pet owner

Pet owners

Non pet owner

Non pet owners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source population will include patients over 18 years of age receiving prophylactic oral antimicrobials for dental implants at the University of Pennsylvania School of Dental Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The Robert Schattner Center, University of Pennsylvania, School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples

MeSH Terms

Conditions

Dysbiosis; Human-Animal Bond; Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Human-Animal Interaction; Behavior; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Laurel Redding, VMD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 21, 2022
• Study Start: May 30, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)