Taste of Medicines in Children

Taste of Medicines in Children: Genetic Variation and Medication Adherence

Some but not all children will refuse to take medicine because of its taste, which can lead to substantial worsening of disease, antibiotic resistance, increased health care costs, and even death. The investigators are systematically assessing individual variation in the taste of liquid clindamycin among genotyped pediatric patients prescribed clindamycin for standard of care treatment, to determine whether (1) genetic variation underlies differences in taste ratings of the antibiotic; (2) initial taste responses, genetics, or both predict likelihood of side effects and medication non-adherence.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Medication Reaction

Detailed Description

Taste plays an integral role in whether a child accepts a medicine. Some children will like the taste of a given medicine and complete the full course of treatment, whereas others will strongly reject its taste, suffer taste-modulated side effects, or both. This study will systematically measure initial palatability and reactions to the first dose of an antibiotic (clindamycin, liquid formulation) by pediatric patients who are receiving clindamycin as part of their standard of care treatment. Saliva will be collected from all patients for GWAS. Taste response, tolerance of the medication, adherence and clinical outcomes will be assessed. Subjects will be followed to determine if they complete the prescribed medication regimen (adherence) and/or experience side effects (tolerability). Because medication-specific side effects have patient-specific variability, the investigators will determine whether the child's initial taste responses, genes, or both predict subsequent side effects and medication adherence.

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

• Study Contact: Name: Elizabeth D Lowenthal, MD, MSCE; Phone Number: 267-426-2306; Email: lowenthale@chop.edu
• Study Contact Backup: Name: Jennifer Chapman, MPH; Email: chapmanj1@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who are prescribed clindamycin liquid at the Children's Hospital of Philadelphia (CHOP).

Description

Inclusion Criteria:

• Children age 3 to 12
• Child being treated in Children's Hospital of Philadelphia
• Being prescribed clindamycin liquid
• Parental/guardian permission (informed consent) and if appropriate, child assent
• Parent age 18 or older, or a minor permitted by state law to consent for their own participation and for the participation of their child
• Parent must have primary responsibility for the patient including biologic parents and adoptive parents (if legally allowed to consent to research)
• Parent must be English speaking and able to understand study materials

Exclusion Criteria:

• Unwilling or unable to produce saliva sample

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of clindamycin liquid	Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)	Immediately after dosing
Palatability of clindamycin liquid	Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)	5 minutes after dosing
Palatability of clindamycin liquid	Taste ratings by the child using a hedonic face scale (scale = 1-5; 1=dislike a lot, 2=dislike a little, 3=neither like nor dislike, 4=like a little, 5=like a lot)	10 minutes after dosing
Taste reactivity of clindamycin liquid	Digital recordings will be analyzed for child's facial and body movements by blinded and trained reviewers	Immediately after dosing for a total of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication tolerance and side effects with clindamycin use	Medication tolerance and side effects to medication will be measured through direct observation, parent report, and medical records	5-14 day treatment regimen given two-three times a day
Treatment adherence	Adherence to treatment course will be measured by parental report aided by a medication diary	5-14 day treatment regimen given two-three times a day
Clinical outcomes	Clinical outcome of infection (cured on clindamycin vs not cured on clindamycin) will be measured through medical record review and parental report during follow-up interview	within 1 week after completion of therapy
Genome-wide association	salivary DNA	3 years

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD); Monell Chemical Senses Center
• Investigators: Principal Investigator: Elizabeth D Lowenthal, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

Helpful Links

• NIH Research Portfolio Online Reporting Tools

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; Taste; personalized medicine; Side effects; GWAS; clindamycin
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 19-016182; R01DC011287 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No