Inflammatory Bowel DiseasesNCT02858557
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
A study testing Mediterranean diet and Specific Carbohydrate Diet in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Dietary Modification
- What is being tested?
- Mediterranean diet and Specific Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to Sep 2018
- 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 aged 18-75;
- Able and willing to sign an informed consent;
- Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.
Who cannot join
- Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, 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
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: The Effect of the Mediterranean Diet and the Specific Carbohydrate Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.
Read the detailed description
Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. However, the relationship between diet, the microbiome and intestinal inflammation is still vague.
The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.
- Being tested
- Mediterranean diet, Specific Carbohydrate Diet
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietBehavioural
The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.
Specific Carbohydrate DietBehavioural
The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet Receives: Behavioral: Mediterranean diet; Behavioral: Specific Carbohydrate Diet |
| Group B | Experimental | Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet Receives: Behavioral: Mediterranean diet; Behavioral: Specific Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial diversity
Shannon α-diversity index
Measured: 7 days
Secondary outcomes (5)
Clinical score
Pouchitis Disease Activity Index (PDAI)
Measured: 7 days
C-reactive protein (CRP)
Inflammatory marker
Measured: 7 days
fecal calprotectin
Inflammatory marker
Measured: 7 days
Quality of life
Inflammatory bowel diseases questionnaire (IBDQ)
Measured: 7 days
Microbial composition
Change in the abundance of microbial taxa
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- 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
- NCT02858557
- Sponsor's protocol ID
- 0240-16-TLV
- Status last verified
- Aug 2016
- First submitted
- 28 Jul 2016
- Last updated
- 8 Aug 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 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mediterranean Diet and the Specific Carbohydrate Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT02858557
- Acronym / sponsor ID
- 0240-16-TLV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 Aug 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 two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.
Detailed description
Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. However, the relationship between diet, the microbiome and intestinal inflammation is still vague.
The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Mediterranean diet, Behavioral: Specific Carbohydrate DietPatients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet |
| Group B | Experimental | Behavioral: Mediterranean diet, Behavioral: Specific Carbohydrate DietPatients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet |
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 aged 18-75;
- Able and willing to sign an informed consent;
- Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.
Key exclusion criteria (1 listed)
- Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, 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 |
|---|---|---|
| Mediterranean dietThe Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats. | Behavioural | Group A, Group B |
| Specific Carbohydrate DietThe specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides. | Behavioural | Group A, Group B |
Primary outcome
Microbial diversity
Time frame: 7 days
Shannon α-diversity index
5 secondary outcomes
Clinical score
Time frame: 7 days
C-reactive protein (CRP)
Time frame: 7 days
fecal calprotectin
Time frame: 7 days
Quality of life
Time frame: 7 days
Microbial composition
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet and Specific Carbohydrate Diet in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Tel-Aviv Sourasky 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 1 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 Aug 2016. 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 Lihi Godny, B.Sc (+9723947305, lihig@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial diversity (time frame: 7 days). 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 Aug 2016.