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Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease (Bio-MDT)

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ClinicalTrials.gov Identifier: NCT04082559
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
Tel Aviv University
Information provided by (Responsible Party):
IRIS DOTAN, Rabin Medical Center

Brief 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. 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:

  1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.
  2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.
  3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.
  4. Identify predictors for response to specific antibiotic and dietary interventions.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Other: Arm 1- Antibiotics treatment Other: Arm 2- Antibiotics treatment Other: Arm 1- Combination therapy (Antibiotics + diet) Other: Arm 2- Combination therapy (Antibiotics + diet) Other: Arm 1- Nutritional prevention Other: Arm 2- Nutritional prevention Other: Arm 3- Nutritional prevention Not Applicable

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.

  1. Ciprofloxacin + metronidazole
  2. 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

  1. Favorable antibiotics + Mediterranean diet (MED)
  2. 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:

  1. Mediterranean diet (MED)
  2. Control- based on the American Dietetic Association recommendations for patients with IBD.
  3. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Biomarker-based Multidisciplinary Team Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : June 11, 2021
Estimated Study Completion Date : June 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Antibiotic treatment

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
Other: Arm 1- Antibiotics treatment
Patients with active disease will be randomized and will receive a prescription antibiotic regimens
Other Name: Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks

Other: Arm 2- Antibiotics treatment
Patients with active disease will be randomized and will receive a prescription antibiotic regimens
Other Name: Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks

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.
Other: Arm 1- Combination therapy (Antibiotics + diet)
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 Name: Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.

Other: Arm 2- Combination therapy (Antibiotics + diet)
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 Name: Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.

Nutritional prevention

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
Other: Arm 1- Nutritional prevention
Patients in clinical remission will be recruited to a dietary prevention study
Other Name: Mediterranean diet

Other: Arm 2- Nutritional prevention
Patients in clinical remission will be recruited to a dietary prevention study
Other Name: Control- based on the American Dietetic Association recommendations for patients with IBD

Other: Arm 3- Nutritional prevention
Patients in clinical remission will be recruited to a dietary prevention study
Other Name: Personalized nutrition group- based on prior results from study- NCT02858557




Primary Outcome Measures :
  1. Time interval to response [ Time Frame: One year ]
    Decrease in PGA and PDAI

  2. Time interval to remission [ Time Frame: One year ]
    PGA=0 and PDAI<7



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients are able and willing to sign an informed consent
  2. Patients with UC who underwent pouch surgery and have a functioning pouch
  3. Disease activity (PDAI and PGA) according to study arm 1-3 inclusion

Exclusion Criteria:

  1. Patients with ileostomy
  2. Significant comorbidity that precludes the patient from participating according to the physicians' judgment
  3. Non-Hebrew readers
  4. Pregnant and lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082559


Contacts
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Contact: Iris Dotan, Prof +97237525015 irisdo@clalit.org.il
Contact: Lihi Godny, BSc +97237525015 lihigodny@gmail.com

Locations
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Israel
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Iris Dotan, Prof    +97237525015    irisdo@clalit.org.il   
Contact: Lihi Godny, BSc    +97237525015    lihigodny@gmail.com   
Sponsors and Collaborators
Rabin Medical Center
The Leona M. and Harry B. Helmsley Charitable Trust
Tel Aviv University

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Responsible Party: IRIS DOTAN, Head of The Gastroenterology Division, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04082559     History of Changes
Other Study ID Numbers: 0129-19-RMC
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRIS DOTAN, Rabin Medical Center:
IBD
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Pouchitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileitis
Enteritis
Ileal Diseases
Anti-Bacterial Agents
Metronidazole
Doxycycline
Ciprofloxacin
Antibiotics, Antitubercular
Complement Factor H
Anti-Infective Agents
Antitubercular Agents
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents