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)
Published: 03/17/2020
General Information:
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.
Eligibility:
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 Details:
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).