Status:
TERMINATED
Synbiotics and Post-op Crohn's Disease
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
W. Garfield Weston Foundation
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Crohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all ...
Detailed Description
Crohn's disease (CD) is characterized by chronic intestinal inflammation and commonly involves the ileocecal region. Due to disease complications, many patients with CD require an ileocecal resection ...
Eligibility Criteria
Inclusion
- Diagnosis of Crohn's disease
- Undergoing ileocolonic resection
- Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraception, intrauterine devices, vasectomy/tubal ligation, barrier methods, double-barrier method) and must have negative pregnancy test results at screening and baseline.
Exclusion
- Subjects which are reliant on partial or total parenteral nutrition
- Subjects with permanent or temporary diverting ileostomies
- Subjects with gluten intolerance/sensitivity
- Subjects with milk or soy allergy
- Subjects with diabetes, immune disorders, or bleeding disorders
- Subjects with any documented psychological disorders
- Pregnant women, women who are breast feeding, or women planning on becoming pregnant
- Subjects with perforation or ischemia of the gut
- Subjects unable to tolerate any oral intake following surgery
- Subjects with immune-compromised condition (e.g. AIDS, lymphoma)
- Subjects who are taking tetracycline
- Subjects with uncontrolled cardiovascular or respiratory disease or active malignancy
- Subjects who are enrolled in another clinical trial
- Subjects who are unable to give informed consent
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04804046
Start Date
July 15 2021
End Date
December 31 2023
Last Update
January 19 2024
Active Locations (5)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
2
Misericordia Community Hospital
Edmonton, Alberta, Canada, T5R 4H5
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2E1
4
University of Alberta Human Nutrition Research Unit
Edmonton, Alberta, Canada, T6G 2E1