Evaluating the Safety and Efficacy of Fecal Microbiota Transplant in Peanut Allergic Patients

This is a study of fecal microbiota transplantation (FMT) in the treatment of peanut allergy.
The primary aim is to assess safety and tolerability of oral FMT in patients with peanut
allergy aged 18-40 years. A total of 10 patients with peanut allergy will be enrolled after
they fail a screening food challenge to peanut. Participating will be given oral encapsulated
frozen FMT over 2 days. Patients will undergo a second and third food challenge after
receiving FMT. The expected duration of the study for each subject will be one year. Stool
collection, skin testing and blood samples will be done serially.

Inclusion Criteria:

1. Allergic reaction during food challenge at 3 mg - 100 mg peanut protein.

2. Positive SPT 5 mm wheal to peanut and/or a positive peanut-specific IgE > 0.35kU/L.

3. Spirometry/Peak Flow with Measurement of FEV1>=80% of predicted.

4. Negative for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus.

5. Negative urine pregnancy test if a female participant.

6. Will use an acceptable double-barrier form of birth control during study.

7. Able to swallow 2 empty capsules size 00.

8. Able to give informed consent .

9. Willing and able to participate in the study requirements.

10. Willing to undergo telephone follow-up.

Exclusion Criteria:

1. History of severe anaphylaxis.

2. Required more than one dose of epinephrine to treat allergic reaction.

3. Other food allergies excluding peanut and tree nuts.

4. Patients with gelatin allergy

5. Chronic illness other than controlled asthma, mild eczema, allergic rhinitis.

6. Infections necessitating frequent systemic antibiotics.

7. History of chronic immunosuppressive therapies.

8. History of other chronic diseases, except for atopic conditions.

9. More than one episode of allergic or non-allergic urticaria within a 2 month span of
time, or history consistent with poorly controlled persistent asthma.

10. Previous participation in a peanut immunotherapy protocol or on aeroallergen
immunotherapy maintenance therapy for less than 6 months or who received Omalizumab
therapy over the past year.

11. Women who are pregnant or breast feeding, or planning to get pregnant during the time
of the study.

12. Sexually active female patients who refuse to use contraception for study.

13. GI conditions including inflammatory bowel disease eosinophilic esophagitis, food
protein induced enterocolitis, reflux, constipation, esophageal dysmotility,
swallowing dysfunction, delayed gastric emptying syndromes, pill esophagitis or
history of aspiration pneumonia within 3 months prior to screening.

14. History of rheumatologic conditions.

15. Direct relative with inflammatory bowel disease.

16. Patients with any form of immunodeficiency.

17. Patients participating or planning to participate in the next year, or have
participated within the prior year in other interventional trials in which
investigational drug therapy was administered.

18. Positive for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus.

19. Systemic antibiotic therapy over the past 6 months or systemic corticosteroids therapy
over the past 3 months.

20. Allergic reaction during food challenge at 1 mg peanut protein.