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临床试验/NCT04329481
NCT04329481Unknown不适用

The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

"Mycodigest" supplementation and placebo will be manufactured by 'Mycolivia Medicinal Mushrooms' LTD, to be identical in size, shape and color.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

结局指标

主要结局

efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates

时间窗: week 18

During the study follow-up remission will be determined by an HBI score \<4 for CD and a SCCAI score \<2 for UC

efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on inflammatory markers

时间窗: week 18

During the study follow-up inflammation markers will be determined by CRP concentration \<5 mg/L, fecal calprotectin concentration \<250 μg/g for both.

次要结局

  • efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life(week 18)
  • effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity(week 18)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eli Sprecher, MD

PI

Tel-Aviv Sourasky Medical Center

研究点 (2)

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