# Lantern Bioworks Protocol Notes

Work log:
1 hour - pre meeting / started this note
1 hour - call about protocol
2 hours - protocol summary/overview (11/10)
Schedule, Administration 11/13
3 hours - adverse events, work in Taiwan/HK
(hand off draft)
2 hours - assayy protocol, logo, glossary, background info 11-27

Todo:
longitudinal data to Heather
ask heather about mix of for profit/not for profit for phase 1
ask about dentist
ask about administration space rental
participate in the pilot?
MD/dentist to be Primary Investigator

Ask Dentist about exclusion criteria

Longitudinal Data:
None of their spouses have gotten it
20 years later, still active

participant screening
inclusion / exclusion

Inclusion:
has had a cavity before

s ratis / cavity immune already
(causes periodontal disease but not relevant for study)
Exclusion:
(consult w/ dentist about what is best)
periodontal disease?
history of cavities in past 2 years ?

Followup procedure:
All participants:
Swab Teeth @ 3 and 12 months
Local to the bay: meet up in person and administer
Non bay-locals: self collection kit

12-13 months: survey
if they do go to dentist: we want the records

Some participants:
possible assessment of gut bacteria?

administration details
todo: ask Heather about dentist
hygienist cleans before administration

enrollment cap
30-50

sites:
Roatan / office
Brut Biolabs - Palo Alto

Quality Assurance:
Lactic acid assay/ ethanol assay / sniff test
Sequenced to confirm to not contain LDH/lactic acid

endpoints:
Primary: Safety for 12 month period post procedure.

Secondary: cavity rates -
pericarditis - autobrewery - dry mouth - dysbiosis - vaginal dysbiosis - breath odor?

Sponsor Details:
Lantern Bioworks - Delaware LLC

Principal Investigator: ... ?