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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04082559
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rabin Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOther
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases
Additional Details

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.

Arms & Interventions

Arms

Other: Antibiotic treatment

Patients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens. Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks

Other: Combination therapy (Antibiotics + diet)

Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks. Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.

Other: Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study. Mediterranean diet Control- based on the American Dietetic Association recommendations for patients with IBD Personalized nutrition group- based on prior results from study- NCT02858557

Interventions

Other: - Arm 1- Antibiotics treatment

Patients with active disease will be randomized and will receive a prescription antibiotic regimens

Other: - Arm 2- Antibiotics treatment

Patients with active disease will be randomized and will receive a prescription antibiotic regimens

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: - 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: - Arm 1- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

Other: - Arm 2- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

Other: - Arm 3- Nutritional prevention

Patients in clinical remission will be recruited to a dietary prevention study

Contact a Trial Team

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International Sites

Rabin Medical Center, Petah Tikva, Israel

Status

Recruiting

Address

Rabin Medical Center

Petah Tikva, ,

Site Contact

Iris Dotan, Prof

irisdo@clalit.org.il

+97237525015

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