Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease

The purpose of this study is to determine if EcoActive is safe and effective in people with
Crohn's disease. EcoActive is a collection of bacteriophages. Bacteriophages (or phages) are
viruses that infect only bacteria. The phages in EcoActive infect a specific type of bacteria
called Adherent Invasive Escherichia coli (AIEC).

The cause of Crohn's disease is poorly understood. However, the presence of AIEC in the
intestines is associated with worsening inflammation in this disease. Inflammation is the
presence of redness, irritation, and ulcers in the intestines. By using phages that only
infect and kill this specific type of bacteria (AIEC), it is the hope this can be used to
improve the course of Crohn's disease. The phages would only target the AIEC, without
affecting the natural, often helpful, bacteria of the intestines. EcoActive may also lessen
the use of antibiotics to control symptoms. When antibiotics are used, they can have major
effects on the rest of the bacteria in the intestines. Also, repeated use can cause
intestinal bacteria to become resistant to antibiotics. Reduced use of antibiotics would
limit both of these risks.

Inclusion Criteria:

1. Male or female ≥ 18 years of age

2. Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw
Index (HBI) < 4

3. Permitted CD medications expected to remain stable during the period of the study (see
Section 7 "Concomitant Crohn's Disease Medications" for allowed and prohibited drugs).

4. Crohn's disease history ≥ 6-month duration

5. CRP (C-reactive protein) within normal range at the Screening visit (based on normal
range of the local laboratory)

6. Fecal calprotectin level ≤ 150 µg/g at the Screening visit

7. AIEC detected in the stool

8. Females of childbearing age must be using an effective method of contraception to
prevent pregnancy and agree to continue to practice an acceptable method of
contraception for the duration of participation in the study (contraceptive measures
considered adequate are: intrauterine devices, hormonal contraceptives, such as
contraceptive pills, implants, transdermal patches, hormonal vaginal devices or
injections with prolonged release).

9. Negative pregnancy test for women of childbearing age (menarche to menopause)

10. Patient understands the study procedures, and can sign the informed consent, and the
authorization to release relevant protected health information to the Study
Investigator.

Exclusion Criteria:

1. Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4

2. Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding

3. Active malignancies or any malignant disease within the past 5 years

4. Indeterminate colitis, ulcerative colitis

5. Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).

6. Colonic or small bowel stoma

7. Active perianal lesions

8. Women who are pregnant or nursing, or plan to become pregnant during the study period

9. Severe uncontrolled diseases that could increase the risk for subjects participating
in the study, including but not limited to: heart diseases, congestive heart failure,
hypertension, lung diseases; endocrine diseases; clinically significant renal disease
characterized by a glomerular filtration rate < 60mL/min, hepatic diseases,
haematological disorders, or other conditions that in the opinion of the Investigator
could interfere with the interpretation of the study results.

10. Taking supplemental probiotics in the form of pills or tablets.

11. History or planned procedures specifically aimed at modifying the gastrointestinal
microbiota within the past year.

12. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior to the
Screening visit or planned during the study period

13. Use of bowel cleansing or preparation for endoscopy, TDM or MRI in the 4 weeks prior
to the Screening visit or planned during the study period.

14. Receipt of antibiotics 4 weeks before the Screening visit or planned during the study
period.

15. Known allergy or hypersensitivity to an excipient in the study drug or placebo

16. Psychological or linguistic incapability to sign the informed consent.

17. Lack or expected lack of cooperation or compliance with the study.

18. Receipt of mesalamine based therapies within 4 weeks of the screening visit.

19. Severe psychiatric, psychological, or neurological disorders.

20. Alcohol, drug or medication abuse within the past year.

21. Subject who cannot be contacted in case of emergency.