RECRUITING

REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Pet Contact on Antimicrobial-associated Dysbiosis and Clostridioides Difficile Infection

Quick Facts

Study Start:2022-05-30
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05622721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older.
  2. * Receiving a dental implant.
  3. * Ability to understand study procedures and to comply with them for the entire length of the study.
  1. * Antimicrobial therapy or hospitalization in the prior three months;
  2. * Any gastrointestinal illness or underlying pathology (e.g., Inflammatory Bowel Disease, gastric ulceration)
  3. * 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;
  4. * Prior history of CDI in the prior year;
  5. * Immunomodulating medication (e.g., tumor necrosis factor inhibitors or systemic steroids) or conditions (e.g., leukemia)
  6. * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Contacts and Locations

Study Contact

Laurel Redding, VMD, PhD
CONTACT
6109256307
lredding@upenn.edu

Principal Investigator

Laurel Redding, VMD, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

The Robert Schattner Center, University of Pennsylvania, School of Dental Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Laurel Redding, VMD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-30
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2022-05-30
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

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