The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

Last updated: January 31, 2022
Sponsor: Tel-Aviv Sourasky Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Ulcers

Colic

Treatment

N/A

Clinical Study ID

NCT04329481
TASMC-17-0643-TLV
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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, orimmunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medicalcannabis 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 theHarvey-Bradshaw index (HBI) score, or HBI < 4 and calprotectin >250 2.2 UC patientswill be included if their symptoms score >3between <11 on the SCCAI score, or UCpatients with SCCAI <3 and calprotectin >250
  3. Patients who agreed to refrain from over the counter (OTC) medications for lower GIsymptoms and dietary supplements or other foods containing fermented live bacteriathroughout the study period

Exclusion

Exclusion Criteria:

  1. Any proven current infection such as Clostridium difficile infection , positive stoolculture, or parasites, in cases when a patient complains of diarrhea and have notpreformed 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) orduring 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, advancedkidney or liver disease, systemic inflammatory conditions other than IBD.
  7. Patients with ileostomy, pouch or short bowel

Study Design

Total Participants: 100
Study Start date:
June 12, 2018
Estimated Completion Date:
June 12, 2024

Study 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

Connect with a study center

  • Department of Gastroentherology

    Tel Aviv, 64239
    Israel

    Active - Recruiting

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