The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases
About this trial
This is an interventional supportive care trial for Ulcerative Colitis focused on measuring ulcerative colitis, crhon's disease, inflammatory bowel disease, mycobiome
Eligibility Criteria
Inclusion Criteria:
- 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:
2.1 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 Criteria:
- 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
Sites / Locations
- Department of GastroentherologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
mycodigest supplement
placebo
"Mycodigest" is a dietary supplement which consists of traditional medicinal mushrooms, as essences and grounded powder. These include Shiitake, Maitake, Trametes Coriolus Versicolor, Agaricus. Compliance to treatment will be considered as taking 80% of supplement/placebo treatment, and will be monitored by telephone calls and emails to patients during the study phase, and by counting the pills which were not taken at the end of the trial. Treatment with "Mycodigest" supplement will initiate with 2 pills/day for 7 days, and gradually rise to 4 pills/day for 7 days, 6 pills/day for 42 days. Thus, the full dose of the treatment will be administered for 6 weeks.
will be be identical in size, shape and color to "Mycodigest" Treatment with "Mycodigest" placebo will initiate with 2 pills/day for 7 days, and gradually rise to 4 pills/day for 7 days, 6 pills/day for 42 days. Thus, the full dose of the treatment will be administered for 6 weeks.