The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients

NCT04329481 | Unknown

• 1 other identifier: TASMC-17-0643-TLV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis; Crohn Disease; Inflammatory Bowel Diseases

Keywords

ulcerative colitis; crhon's disease; inflammatory bowel disease; mycobiome

Outcome Measures

Primary Outcomes (4)

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

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

  week 8

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

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

  week 18

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

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

  week 8

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

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

  week 18

Secondary Outcomes (4)

• efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life

  week 8

• 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 8

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

  week 18

Study Arms (2)

mycodigest supplement

ACTIVE COMPARATOR

"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.

Dietary Supplement: Mycodigest supplement

placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Mycodigest supplement

Interventions

Mycodigest supplement DIETARY_SUPPLEMENT

Mycodigest" is a dietary supplement which consists of traditional medicinal mushrooms, as essences and grounded powder

mycodigest supplement; placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Gastroentherology

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: "Mycodigest" supplementation and placebo will be manufactured by 'Mycolivia Medicinal Mushrooms' LTD, to be identical in size, shape and color.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: June 12, 2018
• Primary Completion: June 12, 2022
• Study Completion: June 12, 2024
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)