Ulcerative ColitisNCT04329481
The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
A study testing Mycodigest supplement in people with Ulcerative Colitis and Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Mycodigest supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Jun 2018to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Gastroentherology
Tel Aviv, 64239
Nitsan Maharshak, MD, 972-3-6972488, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
About this study
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
Read the 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:
- Clinical response and remission rates
- Quality of life
- Inflammatory markers
- Fecal microbiome composition and diversity
- Being tested
- Mycodigest supplement
- Keywords
- ulcerative colitis, crhon's disease, inflammatory bowel disease, mycobiome
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycodigest supplementDietary supplement
Mycodigest" is a dietary supplement which consists of traditional medicinal mushrooms, as essences and grounded powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Mycodigest supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: week 18
Secondary outcomes (4)
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
During the study quality of life will be assessed by filling a quality of life questionnaire that will be compared between the baseline and week 8. The is no scale to the questionnaire.
Measured: week 8
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
During the study quality of life will be assessed by filling a quality of life questionnaire that will be compared between the baseline and week 18. The is no scale to the questionnaire.
Measured: week 18
effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
Fecal microbiome composition and diversity will be assessed by- DNA will be extracted from the stool using PowerLyzer PowerSoil DNA isolation kit (MoBio) for characterizing the microbial composition. DNA extraction will be followed by PCR amplification of the V3-V4 regions of the bacterial 16S rRNA gene, using 515F/806R primers. Last, 500 bp paired-end sequencing will be performed on an Illumina MiSeq. The collected data will be analyzed using the QIIME pipeline. Following the pipeline we will filter and normalize the data by applying a bottom threshold of 0.002 relative abundance to all values under detection level (0 to 0.002) and only taxa. For beta-diversity, unweighted unifrac measurements will be plotted according to the first two principal coordinates based on 9,000 reads per sample.
Measured: week 8
effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
Fecal microbiome composition and diversity will be assessed by- DNA will be extracted from the stool using PowerLyzer PowerSoil DNA isolation kit (MoBio) for characterizing the microbial composition. DNA extraction will be followed by PCR amplification of the V3-V4 regions of the bacterial 16S rRNA gene, using 515F/806R primers. Last, 500 bp paired-end sequencing will be performed on an Illumina MiSeq. The collected data will be analyzed using the QIIME pipeline. Following the pipeline we will filter and normalize the data by applying a bottom threshold of 0.002 relative abundance to all values under detection level (0 to 0.002) and only taxa. For beta-diversity, unweighted unifrac measurements will be plotted according to the first two principal coordinates based on 9,000 reads per sample.
Measured: week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start12 Jun 2018
- Primary completion12 Jun 2022 (estimated)
- Study completion12 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329481
- Sponsor's protocol ID
- TASMC-17-0643-TLV
- Status last verified
- Jan 2022
- First submitted
- 29 Mar 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
- ClinicalTrials.gov ID
- NCT04329481
- Acronym / sponsor ID
- TASMC-17-0643-TLV
- Keywords
- ulcerative colitis, crhon's disease, inflammatory bowel disease, mycobiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 12 Jun 2022 (estimated)
- Study completion
- 12 Jun 2024 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Clinical response and remission rates
- Quality of life
- Inflammatory markers
- Fecal microbiome composition and diversity
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| mycodigest supplement | Active comparator | Dietary Supplement: Mycodigest supplement"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. |
| placebo | Placebo comparator | Dietary Supplement: Mycodigest supplementwill 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycodigest supplementMycodigest" is a dietary supplement which consists of traditional medicinal mushrooms, as essences and grounded powder | Dietary supplement | mycodigest supplement, placebo |
Primary outcome
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates
Time frame: week 8
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 clinical response and remission rates
Time frame: 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
Time frame: week 8
During the study follow-up inflammatory markers will be determined by CRP concentration <5 mg/L, fecal calprotectin concentration <250 μg/g for both.
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on inflammatory markers
Time frame: 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.
4 secondary outcomes
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
Time frame: week 8
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on quality of life
Time frame: week 18
effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
Time frame: week 8
effect of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on 4. Fecal microbiome composition and diversity
Time frame: week 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycodigest supplement in people with Ulcerative Colitis and Crohn Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of "Mycodigest" supplementation to inflammatory bowel disease (IBD) patients on clinical response and remission rates (time frame: week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.