Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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13 November 2023 |
Main ID: |
NCT03808103 |
Date of registration:
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04/01/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease
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Scientific title:
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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) |
Date of first enrolment:
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May 1, 2019 |
Target sample size:
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30 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03808103 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Jennifer Schwartz, PhD |
Address:
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Telephone:
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667-215-2597 |
Email:
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jschwartz@intralytix.com |
Affiliation:
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Name:
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Reezwana Chowdhury, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Name:
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Robert Hirten, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Biological: Bacteriophage preparation
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Biological: Placebo
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Primary Outcome(s)
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Effect on Harvey Bradshaw Index (HBI)
[Time Frame: Up to 6 months]
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Effect on inflammation, as indicated by C-reactive protein (CRP)
[Time Frame: Up to 6 months]
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Incidence of adverse events
[Time Frame: Up to 6 months]
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Severity of adverse events
[Time Frame: Up to 6 months]
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Effect on inflammation, as indicated by fecal calprotectin
[Time Frame: Up to 6 months]
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Secondary Outcome(s)
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Effect on the incidence and levels of AIEC
[Time Frame: Up to 6 months]
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Secondary ID(s)
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ITX/EA-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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