Beginning Assessment of Cutaneous Treatment Efficacy of Roseomonas in Atopic Dermatitis

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Lyophilized Biotherapeutic, Microbiome, Probiotic, Commensal Gram-negative Bacteria, Staphylococcus Aureus, Transepidermal Water Loss, Allergic Diseases Read More

• INCLUSION CRITERIA:

Inclusion Criteria for Young Adults and Adults with AD (Part 1)

1. Age 16+ years
2. SCORAD of at least 10
3. Have a clinical diagnosis of AD with active involvement of the antecubital fossa
4. Willing to allow storage of blood for future research
5. No history of other skin disease
6. Initiated or attempted standard of care therapy at least 6 months prior to enrollment
7. Must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy. The effects of CGN live biotherapy on the developing human fetus are unknown. Adequate contraception must be used consistently, beginning before the first dose and lasting for the duration of study participation. Participants of childbearing potential must have a negative pregnancy test result before they receive CGN live biotherapy. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately.

Inclusion Criteria for Children with AD (Part 2)

1. Age 3-16 years
2. SCORAD of at least 10
3. Have a clinical diagnosis of AD with active involvement of the antecubital fossa
4. Willing to allow storage of blood and bacterial swabs for future research
5. Initiated or attempted standard of care therapy at least 6 months prior to enrollment
6. Participants who have begun menstruating must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) when engaging in sexual activities that can result in pregnancy.

EXCLUSION CRITERIA:

1. Presence of an indwelling venous or arterial catheter
2. Individuals living with anyone with a diagnosed immunodeficiency, cardiac valvular disease, and/of indwelling catheter
3. Precence of allergies to aimkacin, ciprofloxacin, gentamicin, levofloxacin, and tobramycin (which would preclude treatment of any unexpected infection)
4. History of cardiac valvular disease
5. Any history of grade 2 or higher neutropenia or leukopenia
6. Clinical suspicion of immunodeficiency, liver disorder, kidney disorder, and/or HIV
7. Pregnant or breastfeeding
8. Any history of anti-TNF treatment
9. Inability to demonstrate proper bacteria administration procedure despite coaching and training
10. Use of fluoroquinolone or aminoglycoside antibiotics within 2 weeks of enrollment
11. Any condition that, in the opinion of the investigator, contraindicates participation in this Study

Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the investigator.