Status:
UNKNOWN
The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Ulcerative Colitis
Crohn Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Studies demonstrated that fungi have a complex, multifaceted role in the gastrointestinal tract and are active participants in directly influencing health and disease through fungal-bacterial, fungal-...
Detailed Description
Inflammatory bowel diseases ("IBD") are a group of chronic immune-mediated diseases with typical onset during young adulthood and a lifelong course characterized by periods of remission and relapse. I...
Eligibility Criteria
Inclusion
- Clinically stable patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
- Patients will be included if they have mild to moderate disease defines as:
- 1 CD patients will be included if their symptoms score 4\<between \<16 on the Harvey-Bradshaw index (HBI) score, or HBI \< 4 and calprotectin \>250 2.2 UC patients will be included if their symptoms score \>3between \<11 on the SCCAI score, or UC patients with SCCAI \<3 and calprotectin \>250
- Patients who agreed to refrain from over the counter (OTC) medications for lower GI symptoms and dietary supplements or other foods containing fermented live bacteria throughout the study period
Exclusion
- Any proven current infection such as Clostridium difficile infection , positive stool culture, or parasites, in cases when a patient complains of diarrhea and have not preformed those tests in the past 6 months
- Antibiotic use during participation in the study
- Change in medication regimen before study initiation (see inclusion criteria 2) or during the study
- Inability to sign informed consent and complete study protocol
- Pregnancy
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
- Patients with ileostomy, pouch or short bowel
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04329481
Start Date
June 12 2018
End Date
June 12 2024
Last Update
February 1 2022
Active Locations (1)
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1
Department of Gastroentherology
Tel Aviv, Israel, 64239