Oral-Thrush: Oropharyngeal Candidiasis (OPC) and S-ECC

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05761197

Collaborator

Children's Hospital of Philadelphia (Other)

Enrollment

Location

26.4

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall objective of this study is to investigate the association of early Candida infection (known as oral thrush or oropharyngeal candidiasis, OPC) in children during the first year of life with the onset and severity of severe early childhood caries (S-ECC).

Condition or Disease	Intervention/Treatment	Phase
Candida Infection Oral Thrush Early Childhood Caries

Detailed Description

The overall goal of this study is to conduct a longitudinal observational study to investigate the association of early OPC with the onset and severity of S-ECC to better understand the role of Candida (particularly C. albicans) in severe childhood caries. The investigators will test the hypothesis that OPC is associated with S-ECC by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease.

For this study, a total of 60 infants (aged 6-15-month-old) with or without a history of OPC in their first year of life will be enrolled, based on the inclusion and exclusion criteria. Subjects will have their medical/dental history reviewed from medical records. At each study visit (Baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. Dental plaque/oral swab samples will be collected at each study visit. In addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Association of Early Candida Infection (Oral Thrush) and Severe Early Childhood Caries (S-ECC)

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Children with history of OPC Individuals in the non-OPC cohort will be age and sex-matched to individuals in the OPC cohort.
Children without history of OPC Individuals in the OPC cohort will be age and sex-matched to individuals in the non-OPC cohort.

Outcome Measures

Primary Outcome Measures

To explore the association between OPC and S-ECC onset and severity [24 months]
Caries will be measured by ICDAS scoring system; Plaque and oral swab samples will be collected at each study visit (Baseline, 6-month, 12-month,18-month and 24-month follow-ups); Candida strains will be detected using culturing-dependent and -independent sequencing techniques.

Secondary Outcome Measures

To evaluate the influence of OPC on the oral microbiota [24 months]
Microbiome profiling will be done by shot gun sequencing

Other Outcome Measures

To study the role of Candida on biofilm cariogenic properties [24 months]
Candida-bacterial interaction in modulating biofilm development and virulence will be evaluated using validated experimental models

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 15 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female individuals at the age of 6-15-month-old
Must have at least one fully erupted tooth at baseline visit
Parent/guardian willing and able to provide informed consent
With or without a history of OPC (the study team will enroll 30 participants with and 30 participants without a history of OPC)

Exclusion Criteria:

Presence of a systemic medical condition (e.g. Down syndrome etc.)
Presence of an orofacial deformity
Presence of dental caries
Use of systemic antimicrobial therapy within 30 days of the baseline visit
Presence of any condition which, in the opinion of the investigator, makes participation in the project not in the individual's best interest.