This study will evaluate the safety of oral administration of EcoActive to patients with inactive Crohn's disease and how it affects the levels of AIEC in stool.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Orally, twice a day, for a period of fifteen days
Orally, twice a day, for a period of fifteen days
Johns Hopkins Green Spring Station
Lutherville, Maryland, United States
Icahn School of Medicine at Mount Sinai Hospital
New York, New York, United States
Incidence of adverse events
The number of solicited and unsolicited adverse events will be recorded.
Time frame: Up to 6 months
Severity of adverse events
The severity will be graded according to the definitions and values stated in CTCAE V04 v4.
Time frame: Up to 6 months
Effect on Harvey Bradshaw Index (HBI)
The effect on Crohn's disease activity will be evaluated using the HBI.
Time frame: Up to 6 months
Effect on inflammation, as indicated by C-reactive protein (CRP)
The changes in CRP from baseline will be evaluated.
Time frame: Up to 6 months
Effect on inflammation, as indicated by fecal calprotectin
The changes in fecal calprotectin levels from baseline will be evaluated.
Time frame: Up to 6 months
Effect on the incidence and levels of AIEC
The secondary objective is to assess the effect of oral phage administration on the AIEC (CFU/g) in stools of patients receiving phages vs. patients receiving placebo.
Time frame: Up to 6 months
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