Crohn DiseaseNCT05554445
Observational Investigation of the CDED in a Real World IBD Clinic
An observational study of Crohn Disease, run by Eli Sprecher, MD at 2 sites in Israel.
Trial summary
A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 1,000 participants
- Where
- 2 sitesIsrael
- Study dates
- 21 Feb 2022to 1 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CD patients who are prescribed the CDED during their routine clinical dietary therapy at the IBD clinic of the TLVMC.
Who may be able to join
- Age >18 years
- Clinically stable CD patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
- Clinically active disease by CD symptoms score 4 <Harvey-Bradshaw index (HBI) at baseline and Calprotectin>50g/l / endoscopy / imaging proven active disease from the previous 4 months.
Who cannot join
- Inability to sign informed consent and complete study protocol
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Rony Izhar, PhD contact
Israel2 sites, 2 recruiting
- Recruiting
Department of Gastroentherology,Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Nitsan Maharshak, MD, 972-3-6972488, nitsanm@tlvmc.gov.il
Nitsan Maharshak, MD
- Recruiting
Sourasky medical center (Ichilov)
Tel Aviv
Dr. Nitsan Maharshak, MD
About this study
Official title: Observational Investigation of the CDED in a Real World IBD Clinic: Dietician and Patient Adaptations to the Dietary Protocol
A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. The diet is composed of three phases, at the end of the first two phases we will evaluate whether the patient achieved remission and at the end of phase three the maintenance of remission. We intend to study achievement and remission rate in association to the diet adaptations made by dieticians at phase 1 and 2, together with patient's choice off food at the third phase under real world clinical setting and patient lifestyle characteristics.
Read the detailed description
This is a prospective observational study that will follow a cohort of CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy at the IBD clinic of the TLVMC. The CD exclusion diet (CDED), is a whole-food diet designed to reduce exposure to dietary components, hypothesized to negatively affect the microbiome (dysbiosis), intestinal barrier, and intestinal immunity. We intend to follow patients with proven clinically active disease from the previous 4 months. Disease activity will be determined by Harvey-Bradshaw index (4<HBI<16) and Calprotectin>50g.
The diet is composed of three phases, the first two included 5 mandatory foods consumed daily to provide specific fibers and starches as substrates for short chain fatty acids-producing taxa from Firmicutes, as well as sources of lean protein that were low in animal fat to decrease Proteobacteria and improve intestinal permeability, while maintaining a balanced diet. The diet included avoidance or reduction of exposure to foods containing animal/dairy fat, high fat from other sources, wheat, red or processed meat and protein sources rich in taurine, emulsifiers, artificial sweeteners, carrageenans and sulfites. The second phase stepdown diet involves higher exposure to fruits, vegetables, and legumes along with some foods that are reintroduced with restrictions to increase food flexibility and relieve monotony. The third phase of the study, is considered a maintenance phase in which patients are advised to continue practicing the concepts of the previous two phases, but they may generally manage their diet freely.
In this observational study, we aim to describe our real-world experience with the CDED, in a tertiary referral center for IBD patients. We aim to characterize both the adaptations of the first two phases of the diet practiced by IBD dieticians, and the food choices made by patients during the third phase of the diet . We aim to associate both these determinants with clinical remission at the end of phase two and remission maintenance at the end of phase three respectively.
Data collection
Upon visits, patients will be asked to fill in food frequency questionnaire (FFQ), 3-days recall questionnaires, food related quality of life, CD symptom and pain questionnaire. Dieticians will be asked to meticulously describe the adaptations they have performed in the CDED and the reasons for them at baseline, week 6 and 12. The adaptation will be made in accordance to patient's symptoms and disease characteristics.
At each visit, patient will provide a fecal sample which will be used to test for calprotectin, a biochemical marker, specific for intestine inflammation. Together with Harvey-Bradshaw index (HBI) we will determine disease severity and activity levels. Fecal sample will also use to determine and monitor changes in microbiome composition.
Anthropometric and nutritional evaluation
Patient's weight (kg), height (m), waist circumference (cm) will be documented at each study visit, and body mass index (BMI) will be calculated. Handgrip strength will be measured by a handgrip dynamometer (JAMAR® hydraulic hand dynamometer), and body composition by body electrical impedance (INBODY diagnostic weight).
- Conditions
- Crohn Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult CD patients who are prescribed the Crohn disease exclusion diet | Clinically stable CD patients with active disease by CD symptoms score 4 <Harvey-Bradshaw index (HBI) at baseline and Calprotectin>50g/l / endoscopy / imaging proven active disease from the previous 4 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 1
Achievement of clinical remission by the end of the first phase of the diet, will be defined as HBI(Harvey-Bradshaw Index)<4
Measured: week 6, end of phase 1
Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 2
Achievement of clinical remission by the end of the second phase of the diet will be defined as HBI(Harvey-Bradshaw Index)<4
Measured: week 12, end of phase 2
Rate of patients maintaining clinical remission at the end of phase 3
Maintaining clinical remission by the end of the third phase of the diet will be defined as HBI(Harvey-Bradshaw Index)<4
Measured: week 24, end of phase 3
Secondary outcomes (3)
Associations between adaptations of the first phase of the diet practiced by IBD dieticians and clinical remission
We aim to characterize the adaptations of the first phase of the diet practiced by IBD dieticians and associate the adaptations with achieving clinical remission at the end of phase 1.
Dieticians will be asked to meticulously describe the adaptations they have performed in the CDED and the reasons for them at baseline (table 1). A 3 day food diary will be analyzed and associate with achieving remission.
Remission will be determined by HBI<4
Measured: week 6
Associations between adaptations of the second phase of the diet practiced by IBD dieticians and clinical remission
Dieticians will be asked to meticulously describe the adaptations they have performed to the second phase of the diet and the reason for them.
Food diary will be analyzed and associate with achieving remission by the end of phase 2.
Remission will be determined by HBI (Harvey-Bradshaw Index)<4
Measured: week 12
Associations between food choices during the third phase of the diet made by patients and remission maintenance
We aim to characterize the food choices during the third phase of the diet made by patients and its association with maintaining remission at the end of phase 3.
Food choice will be analyzed according to Food frequency questionnaire (FFQ) and food dairy and associate with maintaining remission.
Remission will be determined by HBI (Harvey-Bradshaw Index)<4
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start21 Feb 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Sprecher, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Nitsan Maharshak, MD, Principal investigator, Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554445
- Sponsor's protocol ID
- 0225-21-TLV
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of future collaboration between researchers, all medical information and fecal samples would be transferred in an anonymous manner (it will not include any identifying detalis to partners outside the hospital), and in accordance with a contract approved by the hospital's research and development department.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Investigation of the CDED in a Real World IBD Clinic: Dietician and Patient Adaptations to the Dietary Protocol
- ClinicalTrials.gov ID
- NCT05554445
- Acronym / sponsor ID
- 0225-21-TLV
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eli Sprecher, MDOther government
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Sep 2022 (actual)
- 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.
A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. The diet is composed of three phases, at the end of the first two phases we will evaluate whether the patient achieved remission and at the end of phase three the maintenance of remission. We intend to study achievement and remission rate in association to the diet adaptations made by dieticians at phase 1 and 2, together with patient's choice off food at the third phase under real world clinical setting and patient lifestyle characteristics.
Detailed description
This is a prospective observational study that will follow a cohort of CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy at the IBD clinic of the TLVMC. The CD exclusion diet (CDED), is a whole-food diet designed to reduce exposure to dietary components, hypothesized to negatively affect the microbiome (dysbiosis), intestinal barrier, and intestinal immunity. We intend to follow patients with proven clinically active disease from the previous 4 months. Disease activity will be determined by Harvey-Bradshaw index (4<HBI<16) and Calprotectin>50g.
The diet is composed of three phases, the first two included 5 mandatory foods consumed daily to provide specific fibers and starches as substrates for short chain fatty acids-producing taxa from Firmicutes, as well as sources of lean protein that were low in animal fat to decrease Proteobacteria and improve intestinal permeability, while maintaining a balanced diet. The diet included avoidance or reduction of exposure to foods containing animal/dairy fat, high fat from other sources, wheat, red or processed meat and protein sources rich in taurine, emulsifiers, artificial sweeteners, carrageenans and sulfites. The second phase stepdown diet involves higher exposure to fruits, vegetables, and legumes along with some foods that are reintroduced with restrictions to increase food flexibility and relieve monotony. The third phase of the study, is considered a maintenance phase in which patients are advised to continue practicing the concepts of the previous two phases, but they may generally manage their diet freely.
In this observational study, we aim to describe our real-world experience with the CDED, in a tertiary referral center for IBD patients. We aim to characterize both the adaptations of the first two phases of the diet practiced by IBD dieticians, and the food choices made by patients during the third phase of the diet . We aim to associate both these determinants with clinical remission at the end of phase two and remission maintenance at the end of phase three respectively.
Data collection
Upon visits, patients will be asked to fill in food frequency questionnaire (FFQ), 3-days recall questionnaires, food related quality of life, CD symptom and pain questionnaire. Dieticians will be asked to meticulously describe the adaptations they have performed in the CDED and the reasons for them at baseline, week 6 and 12. The adaptation will be made in accordance to patient's symptoms and disease characteristics.
At each visit, patient will provide a fecal sample which will be used to test for calprotectin, a biochemical marker, specific for intestine inflammation. Together with Harvey-Bradshaw index (HBI) we will determine disease severity and activity levels. Fecal sample will also use to determine and monitor changes in microbiome composition.
Anthropometric and nutritional evaluation
Patient's weight (kg), height (m), waist circumference (cm) will be documented at each study visit, and body mass index (BMI) will be calculated. Handgrip strength will be measured by a handgrip dynamometer (JAMAR® hydraulic hand dynamometer), and body composition by body electrical impedance (INBODY diagnostic weight).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult CD patients who are prescribed the Crohn disease exclusion diet | – | –Clinically stable CD patients with active disease by CD symptoms score 4 <Harvey-Bradshaw index (HBI) at baseline and Calprotectin>50g/l / endoscopy / imaging proven active disease from the previous 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CD patients who are prescribed the CDED during their routine clinical dietary therapy at the IBD clinic of the TLVMC.
Key inclusion criteria (3 listed)
- Age >18 years
- Clinically stable CD patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
- Clinically active disease by CD symptoms score 4 <Harvey-Bradshaw index (HBI) at baseline and Calprotectin>50g/l / endoscopy / imaging proven active disease from the previous 4 months.
Key exclusion criteria (2 listed)
- Inability to sign informed consent and complete study protocol
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 1
Time frame: week 6, end of phase 1
Achievement of clinical remission by the end of the first phase of the diet, will be defined as HBI(Harvey-Bradshaw Index)<4
Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 2
Time frame: week 12, end of phase 2
Achievement of clinical remission by the end of the second phase of the diet will be defined as HBI(Harvey-Bradshaw Index)<4
Rate of patients maintaining clinical remission at the end of phase 3
Time frame: week 24, end of phase 3
Maintaining clinical remission by the end of the third phase of the diet will be defined as HBI(Harvey-Bradshaw Index)<4
3 secondary outcomes
Associations between adaptations of the first phase of the diet practiced by IBD dieticians and clinical remission
Time frame: week 6
Associations between adaptations of the second phase of the diet practiced by IBD dieticians and clinical remission
Time frame: week 12
Associations between food choices during the third phase of the diet made by patients and remission maintenance
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Yes. As part of future collaboration between researchers, all medical information and fecal samples would be transferred in an anonymous manner (it will not include any identifying detalis to partners outside the hospital), and in accordance with a contract approved by the hospital's research and development department.
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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.
Rony Izhar, PhD contact
Nitsan Maharshak, MD principal investigator
Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Eli Sprecher, MD at 2 sites 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 2 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Nitsan Maharshak, MD (03-6974282, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 1 (time frame: week 6, end of phase 1). The study lists 3 primary outcomes in all. 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 12 Oct 2022.