Crohn's DiseaseNCT02825316
Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
A study testing Mediterranean diet and Low residue diet in people with Crohn's Disease, run by michal roll.
Trial summary
This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Mediterranean diet and Low residue diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jan 2019
- 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
- Males and females
- Age: 18-75
- Diagnosis of Crohn's Disease
- Montreal classification- B1
- CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200
- Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy
- Capacity to give informed consent
Who cannot join
- Ileostomy or colostomy
- Exclusive enteral nutrition/ partial enteral nutrition
- History of or current severe systemic diseases
- History of admission due to bowel obstruction
- Positive Clostridium difficile toxin
- Positive Salmonella, Shigella, Campylobacter, stool culture
- Pregnancy or lactation
- Use of antibiotics or steroids one month prior to inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Read the detailed description
The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.
The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.
- Conditions
- Crohn's Disease
- Being tested
- Mediterranean diet, Low residue diet
- Keywords
- Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
Low residue dietBehavioural
Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients with active Crohn's disease that will be allocated to the Mediterranean diet group. Receives: Behavioral: Mediterranean diet |
| Group B | Experimental | Patients with active Crohn's disease that will be allocated to the low residue diet group. Receives: Behavioral: Low residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index (CDAI)
Change from baseline
Measured: 8 weeks
Secondary outcomes (5)
C-reactive protein
Change from baseline
Measured: 8 weeks
Fecal calprotectin
Change from baseline
Measured: 8 weeks
Remission rate- CDAI<150 + normal CRP/ fecal calprotectin
Measured: 52 weeks
Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin
Measured: 8 weeks
Microbial composition
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- michal roll
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Iris Dotan, MD, Principal investigator, Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825316
- Sponsor's protocol ID
- 0569-15TLV
- Status last verified
- Jun 2016
- First submitted
- 4 Jul 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02825316
- Acronym / sponsor ID
- 0569-15TLV
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- michal rollOther government
- Study start
- Jul 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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.
This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Detailed description
The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.
The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.
Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Mediterranean dietPatients with active Crohn's disease that will be allocated to the Mediterranean diet group. |
| Group B | Experimental | Behavioral: Low residue dietPatients with active Crohn's disease that will be allocated to the low residue diet group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females
- Age: 18-75
- Diagnosis of Crohn's Disease
- Montreal classification- B1
- CDAI: 150-450 + CRP>0.5 or fecal calprotectin >200
Key exclusion criteria (8 listed)
- Ileostomy or colostomy
- Exclusive enteral nutrition/ partial enteral nutrition
- History of or current severe systemic diseases
- History of admission due to bowel obstruction
- Positive Clostridium difficile toxin
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 |
|---|---|---|
| Mediterranean dietEight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat). | Behavioural | Group A |
| Low residue dietEight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains). | Behavioural | Group B |
Primary outcome
Crohn's Disease Activity Index (CDAI)
Time frame: 8 weeks
Change from baseline
5 secondary outcomes
C-reactive protein
Time frame: 8 weeks
Fecal calprotectin
Time frame: 8 weeks
Remission rate- CDAI<150 + normal CRP/ fecal calprotectin
Time frame: 52 weeks
Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin
Time frame: 8 weeks
Microbial composition
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Iris Dotan, MD principal investigator
Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Low residue diet in people with Crohn's Disease, run by michal roll.
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 7 inclusion and 8 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Lihi Godny, B.Sc (97236947305, lihigodny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (CDAI) (time frame: 8 weeks). 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 7 Jul 2016.