Oral Microbiome and Inflammation in Pediatric Headache

The primary goal of this study is to determine if the oral microbiome and inflammation (oral
and systemic) is different in children and adolescents with severe and frequent headaches
compared with age and sex matched controls without headaches and also compared with patients
with less frequent and severe headaches. This is study enrolling both cases (migraine,
tension-type headaches, post-traumatic headaches, and other headache disorders) and controls
(without headaches). Participants will undergo a single day in-person study visit. They will
provide samples of oral wash and saliva and have the option to provide a blood sample.
Additionally they will complete a detailed questionnaire about their headaches and overall
health and oral hygiene.

Inclusion Criteria:

- Inclusion Criteria for participants with Headache

1. Males or females age 10 to 21 years, inclusive

2. Diagnosis of migraine, tension-type headache,post-traumatic headache per
established criteria by the International Classification of Headache Disorders
(ICHD-3 beta) or other headache disorders

Inclusion Criteria for healthy controls

1. Males or females age 10 to 21 years, inclusive

2. No headache within the last year other than tension-type headache with a frequency of
1 or less per month.

Exclusion Criteria:

- Exclusion Criteria for all participants

1. Body temperature over 99.5 F measured with handheld thermometer in the forehead.

2. Smoking (current or former)

3. Known active periodontitis, gingivitis, or dental caries.

4. Major medical or psychiatry illness (e.g. diabetes, major depression/anxiety)

5. Known current upper respiratory infection/symptoms (fever, cold, cough, or sore
throat)

6. History of asthma requiring treatment in the last year.

7. Treatment with probiotic therapy in the 2 weeks prior to participation in the
study. (Probiotics include products marketed specifically to change the gut
microbiome by providing live bacteria. Standard composition yogurt will not be
considered a probiotic.)

8. Treatment with antibiotics or steroids within the previous 3 months.