The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
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-fungal and fungal-host interactions.

 Fungi have been linked with a number of gastrointestinal diseases including IBD, However, the
 exact role of fungal colonization in the pathophysiology of "IBD" (inflammatory bowel
 diseases) is not precisely defined.

 Aim to evaluate the impact of "Mycodigest" supplementation to IBD patients on: Clinical
 response and remission rates , Quality of life, Inflammatory markers, Fecal microbiome
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. IBDs involving two main clinical forms- Crohn's disease ("CD") and
 ulcerative colitis (UC). CD can affect any part of the gastrointestinal tract with the
 frequent presentation of abdominal pain, fever, weight loss, and clinical signs of bowel
 obstruction or diarrhea. In comparison,ulcerative colitis ("UC), in which Inflammation is
 restricted to the mucosal surface of the colon, manifesting as continuous areas of
 inflammation, ulceration, edema and hemorrhage. Usually both conditions are chronic, though
 ulcerative colitis is curable by surgical removal of the colon. Apart from this, there is no
 cure for IBD. both CD and UC can be treated with medications that induce and maintain
 remission. Pharmaceutical treatment includes five major categories, namely anti-inflammatory
 drugs, immune suppressants, biologic agents, antibiotics, and drugs for symptomatic relief.
 Choice of therapy depends largely on the severity of disease, and may also be influenced by
 such factors as disease location, side effects and adverse events, as well as cost. The
 etiology of IBD has been extensively studied in the past few decades however, the
 pathogenesis is not well understood. several factors that make a major contribution to
 disease pathogenesis have been identified and distinct to three categories: genetic factors,
 environmental factors including breast feeding, diet, smoking, drugs etc and microbial
 factors, producing sustained inflammation supported by altered mucosal barrier and defects in
 immune system. This combination of features has made IBD both an appropriate and a
 high-priority platform for translatable research in host-microbiome interactions.

 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-fungal and fungal-host interactions.

 Fungi have been linked with a number of gastrointestinal diseases including IBD, However, the
 exact role of fungal colonization in the pathophysiology of IBD is not precisely defined.
 study have shown that the diversity and composition of the fungal communities varies in IBD.

 A study that characterized the fungal microbiota in the intestinal mucosa and feces in
 patients with CD found that the fungal richness significantly elevated in the inflamed mucosa
 compared with the noninflamed mucosa.

 This suggests that in IBD, the mycobiome and microbiome have a mutual influence on each
 other. Pointing to the role of the bacteria and microbial dysbiosis in IBD.

 Aims

 To evaluate the impact of "Mycodigest" supplementation to inflammatory bowel disease (IBD)
 patients on:

 1. Clinical response and remission rates

 2. Quality of life

 3. Inflammatory markers

 4. Fecal microbiome composition and diversity
Inclusion Criteria:

 1. 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.

 2. 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

 3. 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:

 1. 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

 2. Antibiotic use during participation in the study

 3. Change in medication regimen before study initiation (see inclusion criteria 2) or
 during the study

 4. Inability to sign informed consent and complete study protocol

 5. Pregnancy

 6. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced
 kidney or liver disease, systemic inflammatory conditions other than IBD.

 7. Patients with ileostomy, pouch or short bowel