A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia coli (AIEC) in Patients With Inactive Crohn’s Disease (CD)
The study objectives are to: 1) assess the safety of oral administration of EcoActive (twice daily, for 15 days) in patients with clinically inactive Crohn’s disease having Adherent Invasive Escherichia coli (AIEC) present in their stools; and, 2) evaluate changes in AIEC incidence and levels in stools of patients receiving treatment versus placebo-treated controls.
Key Inclusion Criteria:
- Adults ≥ 18 years of age
- Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) < 4
- Crohn's disease history ≥ 6-month duration
- AIEC detected in the stool
Key Exclusion Criteria:
- Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4
- Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding
- Indeterminate colitis, ulcerative colitis
- Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis)
- Colonic or small bowel stoma
- Active perianal lesions
Study Phase: 1/2a
The study lasts 6 months and includes 1 initial eligibility visit and 5 visits after qualifying for the study.
If you qualify, you will be asked to do the following:
- Visit the clinic 5 times for monitoring over 6 months after starting the study
- Keep a daily diary to record any side effects during the first 3 weeks
- Prepare and drink the experimental medicine at home twice a day for the first 15 days
- Provide blood, urine and stool samples at specific times during the study
Possible Risks & Side Effects
The side effects of the experimental medicine EcoActive are not known. Possible side effects will be reviewed at the eligibility (or screening visit).