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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Johns Hopkins University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dose is 1mL of placebo given orally twice a day for 15 days |
|
| Phage | Experimental | Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Orally, twice a day, for a period of fifteen days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The number of solicited and unsolicited adverse events will be recorded. | Up to 6 months |
| Severity of adverse events | The severity will be graded according to the definitions and values stated in CTCAE V04 v4. | Up to 6 months |
| Effect on Harvey Bradshaw Index (HBI) | The effect on Crohn's disease activity will be evaluated using the HBI. | Up to 6 months |
| Effect on inflammation, as indicated by C-reactive protein (CRP) | The changes in CRP from baseline will be evaluated. | Up to 6 months |
| Effect on inflammation, as indicated by fecal calprotectin | The changes in fecal calprotectin levels from baseline will be evaluated. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hirten, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Reezwana Chowdhury, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Green Spring Station | Lutherville | Maryland | 21093 | United States | ||
| Icahn School of Medicine at Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33310655 | Derived | Lenneman BR, Fernbach J, Loessner MJ, Lu TK, Kilcher S. Enhancing phage therapy through synthetic biology and genome engineering. Curr Opin Biotechnol. 2021 Apr;68:151-159. doi: 10.1016/j.copbio.2020.11.003. Epub 2020 Dec 10. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Bacteriophage preparation | Biological | Orally, twice a day, for a period of fifteen days |
|
|
| New York |
| New York |
| 10029 |
| United States |
| D007410 | Intestinal Diseases |