Inflammatory Bowel DiseasesBio-MDTNCT04082559
Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
A study testing Arm 1- Antibiotics treatment, Arm 2- Antibiotics treatment and Arm 1- Combination therapy (Antibiotics + diet) in people with Inflammatory Bowel Diseases, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Arm 1- Antibiotics treatment, Arm 2- Antibiotics treatment and Arm 1- Combination therapy (Antibiotics + diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Jun 2019to 11 Jun 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are able and willing to sign an informed consent
- Patients with UC who underwent pouch surgery and have a functioning pouch
- Disease activity (PDAI and PGA) according to study arm 1-3 inclusion
Who cannot join
- Patients with ileostomy
- Significant comorbidity that precludes the patient from participating according to the physicians' judgment
- Non-Hebrew readers
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Iris Dotan, Prof, +97237525015, irisdo@clalit.org.il
Lihi Godny, BSc, +97237525015, lihigodny@gmail.com
About this study
Official title: Biomarker-based Multidisciplinary Team Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis").
Based on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch.
Read more
Aims:
- Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.
- Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.
- Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.
- Identify predictors for response to specific antibiotic and dietary interventions.
Read the detailed description
All patients will undergo comprehensive screening by the bio-MDT.
Aim 1: Antibiotic treatment- (patients with active disease) will be randomized to receive a prescription for one of two antibiotic regimens.
- Ciprofloxacin + metronidazole
- Doxycycline+ metronidazole
Aim 2: Combination therapy ( Antibiotics+diet) After arm 1 recruitment completion, a favorable antibiotic regimen will be determined and recommended in arm 2, in which, patients with active disease will be randomized to
- Favorable antibiotics + Mediterranean diet (MED)
- Favorable antibiotics + The Specific Carbohydrate Diet (SCD)
Aim 3: Nutritional prevention-
Patients in clinical remission will be recruited to a dietary prevention study and be allocated to one of three groups:
- Mediterranean diet (MED)
- Control- based on the American Dietetic Association recommendations for patients with IBD.
- Personalized nutrition group- based on prior results from study- NCT02858557
Comprehensive assessment including nutritional, clinical, inflammatory and microbial parameters will be performed at baseline and at weeks 2,3,4,8,26, 52.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Arm 1- Antibiotics treatment, Arm 2- Antibiotics treatment, Arm 1- Combination therapy (Antibiotics + diet), Arm 2- Combination therapy (Antibiotics + diet), Arm 1- Nutritional prevention
- Keywords
- IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1- Antibiotics treatmentOther
Also called Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks
Patients with active disease will be randomized and will receive a prescription antibiotic regimens
Arm 2- Antibiotics treatmentOther
Also called Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks
Patients with active disease will be randomized and will receive a prescription antibiotic regimens
Arm 1- Combination therapy (Antibiotics + diet)Other
Also called Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.
Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
Arm 2- Combination therapy (Antibiotics + diet)Other
Also called Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.
Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
Arm 1- Nutritional preventionOther
Also called Mediterranean diet
Patients in clinical remission will be recruited to a dietary prevention study
Arm 2- Nutritional preventionOther
Also called Control- based on the American Dietetic Association recommendations for patients with IBD
Patients in clinical remission will be recruited to a dietary prevention study
Arm 3- Nutritional preventionOther
Also called Personalized nutrition group- based on prior results from study- NCT02858557
Patients in clinical remission will be recruited to a dietary prevention study
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic treatment | Other | Patients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens.
1. Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks
2. Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks Receives: Other: Arm 1- Antibiotics treatment; Other: Arm 2- Antibiotics treatment |
| Combination therapy (Antibiotics + diet) | Other | 1. Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.
2. Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks. Receives: Other: Arm 1- Combination therapy (Antibiotics + diet); Other: Arm 2- Combination therapy (Antibiotics + diet) |
| Nutritional prevention | Other | Patients in clinical remission will be recruited to a dietary prevention study.
1. Mediterranean diet
2. Control- based on the American Dietetic Association recommendations for patients with IBD
3. Personalized nutrition group- based on prior results from study- NCT02858557 Receives: Other: Arm 1- Nutritional prevention; Other: Arm 2- Nutritional prevention; Other: Arm 3- Nutritional prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval to response
Decrease in PGA and PDAI
Measured: One year
Time interval to remission
PGA=0 and PDAI<7
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start11 Jun 2019
- Primary completion11 Jun 2021 (estimated)
- Study completion11 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Tel Aviv University
- Responsible party
- Principal investigator, IRIS DOTAN, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082559
- Sponsor's protocol ID
- 0129-19-RMC
- Acronym
- Bio-MDT
- Status last verified
- Oct 2020
- First submitted
- 28 Aug 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-based Multidisciplinary Team Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
- ClinicalTrials.gov ID
- NCT04082559
- Acronym / sponsor ID
- Bio-MDT / 0129-19-RMC
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Tel Aviv University
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 11 Jun 2021 (estimated)
- Study completion
- 11 Jun 2023 (estimated)
- First posted
- 9 Sep 2019 (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.
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis").
Based on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch.
Aims:
- Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.
- Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.
- Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.
- Identify predictors for response to specific antibiotic and dietary interventions.
Detailed description
All patients will undergo comprehensive screening by the bio-MDT.
Aim 1: Antibiotic treatment- (patients with active disease) will be randomized to receive a prescription for one of two antibiotic regimens.
- Ciprofloxacin + metronidazole
- Doxycycline+ metronidazole
Aim 2: Combination therapy ( Antibiotics+diet) After arm 1 recruitment completion, a favorable antibiotic regimen will be determined and recommended in arm 2, in which, patients with active disease will be randomized to
- Favorable antibiotics + Mediterranean diet (MED)
- Favorable antibiotics + The Specific Carbohydrate Diet (SCD)
Aim 3: Nutritional prevention-
Patients in clinical remission will be recruited to a dietary prevention study and be allocated to one of three groups:
- Mediterranean diet (MED)
- Control- based on the American Dietetic Association recommendations for patients with IBD.
- Personalized nutrition group- based on prior results from study- NCT02858557
Comprehensive assessment including nutritional, clinical, inflammatory and microbial parameters will be performed at baseline and at weeks 2,3,4,8,26, 52.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibiotic treatment | Other | Other: Arm 1- Antibiotics treatment, Other: Arm 2- Antibiotics treatmentPatients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens. 1. Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks 2. Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks |
| Combination therapy (Antibiotics + diet) | Other | Other: Arm 1- Combination therapy (Antibiotics + diet), Other: Arm 2- Combination therapy (Antibiotics + diet)1. Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks. 2. Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks. |
| Nutritional prevention | Other | Other: Arm 1- Nutritional prevention, Other: Arm 2- Nutritional prevention, Other: Arm 3- Nutritional preventionPatients in clinical remission will be recruited to a dietary prevention study. 1. Mediterranean diet 2. Control- based on the American Dietetic Association recommendations for patients with IBD 3. Personalized nutrition group- based on prior results from study- NCT02858557 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are able and willing to sign an informed consent
- Patients with UC who underwent pouch surgery and have a functioning pouch
- Disease activity (PDAI and PGA) according to study arm 1-3 inclusion
Key exclusion criteria (4 listed)
- Patients with ileostomy
- Significant comorbidity that precludes the patient from participating according to the physicians' judgment
- Non-Hebrew readers
- Pregnant and lactating women
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 |
|---|---|---|
| Arm 1- Antibiotics treatmentAlso: Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeksPatients with active disease will be randomized and will receive a prescription antibiotic regimens | Other | Antibiotic treatment |
| Arm 2- Antibiotics treatmentAlso: Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeksPatients with active disease will be randomized and will receive a prescription antibiotic regimens | Other | Antibiotic treatment |
| Arm 1- Combination therapy (Antibiotics + diet)Also: Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD). | Other | Combination therapy (Antibiotics + diet) |
| Arm 2- Combination therapy (Antibiotics + diet)Also: Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD). | Other | Combination therapy (Antibiotics + diet) |
| Arm 1- Nutritional preventionAlso: Mediterranean dietPatients in clinical remission will be recruited to a dietary prevention study | Other | Nutritional prevention |
| Arm 2- Nutritional preventionAlso: Control- based on the American Dietetic Association recommendations for patients with IBDPatients in clinical remission will be recruited to a dietary prevention study | Other | Nutritional prevention |
| Arm 3- Nutritional preventionAlso: Personalized nutrition group- based on prior results from study- NCT02858557Patients in clinical remission will be recruited to a dietary prevention study | Other | Nutritional prevention |
Primary outcome
Time interval to response
Time frame: One year
Decrease in PGA and PDAI
Time interval to remission
Time frame: One year
PGA=0 and PDAI<7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
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 Arm 1- Antibiotics treatment, Arm 2- Antibiotics treatment and Arm 1- Combination therapy (Antibiotics + diet) in people with Inflammatory Bowel Diseases, run by Rabin 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 3 inclusion and 4 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 8 Oct 2020. 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. 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?
Contact Iris Dotan, Prof (+97237525015, irisdo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval to response (time frame: One year). The study lists 2 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 8 Oct 2020.