Clinical trial NCT04329481: The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
Official title: The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Crohn Disease
Inflammatory Bowel Diseases
Keywords: ulcerative colitis
crhon's disease
inflammatory bowel disease
mycobiome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The crossover study design is suitable for the aims of this study given that Crhon disease (CD) and ulcerative colitis (UC) patients are both chronic conditions. The treatment investigated is hypothesized to effect patient's symptoms and consequent quality of life.

Patients will be screened and randomly allocated to be treated with 'Mycodigest' supplementation or placebo for 8 weeks.

Between the two interventional periods, all participants will undergo a wash-out period of 2 weeks in order to address the potential carryover effect of the first period. As the microbiome is known change rapidly, we assume that this time period will be suitable for minimizing the potential carryover effect of the first period intervention
Primary purpose: SUPPORTIVE_CARE

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-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

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. 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

Eligibility criteria: 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

Primary outcomes:
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates
timeFrame: week 8
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates
timeFrame: week 18
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on inflammatory markers
timeFrame: week 8
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on inflammatory markers
timeFrame: week 18
Secondary outcomes:
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
timeFrame: week 8
measure: efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
timeFrame: week 18
measure: effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
timeFrame: week 8
measure: effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
timeFrame: week 18
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology
Study officials:
References: