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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| Tel Aviv University | OTHER |
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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:
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.
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
Aim 3: Nutritional prevention-
Patients in clinical remission will be recruited to a dietary prevention study and be allocated to one of three groups:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic treatment | Other | Patients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens.
|
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| Combination therapy (Antibiotics + diet) | Other |
|
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| Nutritional prevention | Other | Patients in clinical remission will be recruited to a dietary prevention study.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1- Antibiotics treatment | Other | Patients with active disease will be randomized and will receive a prescription antibiotic regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time interval to response | Decrease in PGA and PDAI | One year |
| Time interval to remission | PGA=0 and PDAI<7 | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Dotan, Prof | Contact | +97237525015 | irisdo@clalit.org.il | |
| Lihi Godny, BSc | Contact | +97237525015 | lihigodny@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
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| Arm 2- Antibiotics treatment | Other | Patients with active disease will be randomized and will receive a prescription antibiotic regimens |
|
|
| Arm 1- Combination therapy (Antibiotics + diet) | Other | 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 | 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 prevention | Other | Patients in clinical remission will be recruited to a dietary prevention study |
|
|
| Arm 2- Nutritional prevention | Other | Patients in clinical remission will be recruited to a dietary prevention study |
|
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| Arm 3- Nutritional prevention | Other | Patients in clinical remission will be recruited to a dietary prevention study |
|
|
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D008795 | Metronidazole |
| D004318 | Doxycycline |
| D000900 | Anti-Bacterial Agents |
| D004032 | Diet |
| D000074584 | WW Domain-Containing Oxidoreductase |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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