Inflammatory Bowel DiseasesPIONIRNCT05211518
Prevention of Inflammatory Bowel Diseases in Persons at Risk The PIONIR (Preventing IBD Onset in Individuals at Risk) Trial
A study testing Tasty&Healthy and Habitual diet in people with Inflammatory Bowel Diseases, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The goal of this study is to explore in a cross over randomized controlled trial, the ability of the Tasty\&Healthy dietary intervention (NCT04239248) to alter the parameters associated with future risk of developing Chron's disease (CD) using First Degree Relatives of patients with Crohn's disease, including subjects… Read more about this study
- Who is it for?
- Ages 6 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Tasty&Healthy and Habitual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIsrael
- Study dates
- 4 May 2021to 15 Jan 2026
- 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 6 to 38 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)\>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD.
- Younger than 39 years of age, in order to maximize future risk of developing CD.
- No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are \>70μg/g.
Who cannot join
- Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis
- The use of antibiotics in the preceding month
- Prior intestinal resection
- Pregnancy (and up until six months after giving birth)
- Celiac disease or Diabetes
- Weight loss or weight gain by more than 20% body weight in the last 3 months
- Extraintestinal manifestations (Arthritis/arthralgia, iritis/uveitis, skin/mouth lesions, peri-anal disease, Other fistula).
- Underweight (children \<3th BMI percentile, adult above the age of 18 years: BMI\<18.5 kg/m2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing IBD Onset in Individuals at Risk
The goal of this study is to explore in a cross over randomized controlled trial, the ability of the Tasty\&Healthy dietary intervention (NCT04239248) to alter the parameters associated with future risk of developing Chron's disease (CD) using First Degree Relatives of patients with Crohn's disease, including subjects identified in the Genetic Environmental Microbiome (GEM) Study as having a high-risk score. Specifically, the investigators aim to determine if the Tasty\&Healthy dietary intervention can decrease the overall GEM Risk Score (GRS) and/or to alter the individual biological parameters that contribute to this score. The investigators hypothesize that the Tasty\&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GRS.
Read the detailed description
Several important factors associated with CD onset have already been identified in the GEM analyses, such as elevated faecal calprotectin(FC),altered gut permeability, proteomics, anti-microbial serology, and microbiome composition. These parameters are combined into the GEM Risk Score (GRS).
The first-line therapy in children with CD, according to ECCO/ESPGHAN guidelines, is exclusive enteral nutrition (EEN), meaning 8-12 weeks of exclusive liquid formula. Nutritional therapy may alter intestinal inflammation by several mechanisms, including modulation of the microbiome and an effect on intestinal permeability, both factors assessed in the GEM cohort. EEN is safe and effective, but it is challenging to implement.
Several diets, based on solid foods, have been proposed as alternatives to EEN in an attempt to increase feasibility, three of which have the most data.
Specific carbohydrate diet (SCD) restricts carbohydrates and processed foods and has been long used with variable reported effectiveness.
The CD-TREAT diet induced a positive change to the microbiome, children with active CD entered clinical remission with decreased inflammatory markers.
Crohn's Disease Exclusion Diet (CDED) is based on the exclusion of processed and pro-inflammatory foods, similar to Tasty\&Healthy. A recent RCT of CDED diet with 50% liquid formula showed comparable effectiveness as EEN, including normalization of FC and positive effect on the microbiome.
However, the allowed dietary components are not liberal, and the diet is rigid, making it unsuitable as a prevention measure.
In 2014, a cook-book named "Tasty\&Healthy" was published as a simple approach to dietary treatment based on the best available evidence. A steering committee of physicians experienced in IBD and nutrition, as well as leading IBD dieticians, reviewed results of dietary studies from animal models, humans and epidemiological cohorts. This review resulted in agreed-upon foods that may aggravate inflammation and thus should be excluded, including all processed and industrialized food, animal fat (dairy, meat), gluten and sugar. Overall, allowed foods in liberal quantities are those prepared at home from readily available ingredients such as fruits, vegetables, fish and shellfish, poultry, oats, eggs, non-gluten grains and legumes. Tasty\&Healthy is not a specific diet; it is a dietary approach in which the allowed foods are not structured or restricted. This approach allows flexibility to increase adherence In this study, The Investigators hypothesize that the Tasty\&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GEM CD risk score or alteration of its individual components.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Tasty&Healthy, Habitual diet
- Keywords
- Chron
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasty&HealthyOther
exclude pro-inflammatory dietary components
Habitual dietOther
subjects will continue their habitual diet.
| Study group | Role | What they receive |
|---|---|---|
| Tasty&Healthy | Other | Tasty\&Healthy intervention: subjects will receive dietary advice to exclude pro-inflammatory dietary components Receives: Other: Tasty&Healthy |
| Habitual diet | Other | Habitual diet: subjects will continue their habitual diet. Receives: Other: Habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity.
Fecal calprotectin (FC) is a validated, sensitive marker of intestinal inflammation and reflects short term biological changes expected from the Tasty \& Healthy intervention. For this reason, the primary endpoint is a reduction in FC over the 8 weeks of the intervention.
Measured: 8 weeks of Tasty&Healthy diet.
Secondary outcomes (9)
Change in the GEM integrative risk score
The GEM integrative risk score assesses how a participant's composite GEM risk score changes from baseline to after the intervention. The iGRS integrates multiple biological markers to reflect overall risk for developing Crohn's disease. A reduction in the score would indicate a favorable shift in these modifiable risk factors.
Measured: 8 weeks of Tasty & Healthy intervention
Change in Microbiome risk score (MRS)
Decreased level of Microbiome risk score. The Microbiome risk score is a test we develop to classify individuals according to their risk to develop Crohn's disease onset.
Measured: 8 weeks of Tasty&Healthy diet.
Change in Lactulose-Mannitol Ratio (LMR).
Decreased level of urinary fractional excretion ratio of Lactulose to Mannitol (LMR). The LMR is an in vivo test that allow quantification of intestinal barrier permeability that is associated with risk to develop Crohn's disease.
Measured: 8 weeks of Tasty&Healthy diet.
Change in Serum Metabolomics pre and post-intervention
Change in levels of stool, urine, and serum metabolites. Metabolomics allow assessment of host chemical processes involving metabolites, small molecule substrates, intermediates and products of cell or microbial metabolism. Unit of measure is raw area count rescaled to set the median equal to 1.
Measured: 8 weeks of Tasty&Healthy diet.
Change in Serum Proteomics pre and post-intervention
Change in serum proteomics. Proteomics allows to assess initiators of most biological processes such as enzymes, cytokines, and transcription factors that contribute to Crohn's disease onset. Unit of measure is normalized protein expression.
Measured: 8 weeks of Tasty&Healthy diet.
Ability to maintain a balanced diet as measured by food diaries.
Will be assessed by daily caloric intake and nutritional components.
Measured: 8 weeks of Tasty&Healthy diet.
Adherence with the interventions, including assessment of faecal gluten.
Will be assessed using ELISA kit- Buhlman fCAL Elisa
Measured: 8 weeks of Tasty&Healthy diet.
Satisfaction with the treatment received, as assessed by the Satisfaction with Food-Related Life (SFRL) questionnaire.
Will be assessed by the SFRL questionnaire - Grunert KG, Dean M, Raats MM, Nielsen NA, Lumbers M; Food in Later Life Team. A measure of satisfaction with food-related life. Appetite. 2007 Sep;49(2):486-93. doi: 10.1016/j.appet.2007.03.010. Epub 2007 Mar 24. PMID: 17481776.
Measured: 8 weeks of Tasty&Healthy diet.
Change in routine blood biomarkers over the course of the 8 week intervention
Biomarkers will be measured at baseline, and end of each intervention in hospital laboratories.
Measured: 8 weeks of Tasty&Healthy intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start4 May 2021
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital, The Hospital for Sick Children, The Governors of the University of Alberta, University of Manitoba, IWK Health Centre, University of British Columbia, University of Calgary, McGill University, Beilinson Hospital, Petach Tikva,Israel
- Responsible party
- Principal investigator, Dr Dan Turner, Shaare Zedek Medical Center
- Investigators
- Dan Turner, Prof, Principal investigator, Saare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211518
- Sponsor's protocol ID
- PIONIR trial
- Acronym
- PIONIR
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stulman MY, Asayag N, Focht G, Brufman I, Cahan A, Ledderman N, Matz E, Chowers Y, Eliakim R, Ben-Horin S, Odes S, Dotan I, Balicer RD, Benchimol EI, Turner D. Epidemiology of Inflammatory Bowel Diseases in Israel: A Nationwide Epi-Israeli IBD Research Nucleus Study. Inflamm Bowel Dis. 2021 Oct 20;27(11):1784-1794. doi: 10.1093/ibd/izaa341.
PubMed 33438721Department of Error. Lancet. 2020 Oct 3;396(10256):e56. doi: 10.1016/S0140-6736(20)32028-6. No abstract available.
PubMed 33010847Beard JA, Franco DL, Click BH. The Burden of Cost in Inflammatory Bowel Disease: A Medical Economic Perspective and the Future of Value-Based Care. Curr Gastroenterol Rep. 2020 Jan 30;22(2):6. doi: 10.1007/s11894-020-0744-z.
PubMed 32002671Barnes C, Ashton JJ, Borca F, Cullen M, Walker DM, Beattie RM. Children and young people with inflammatory bowel disease attend less school than their healthy peers. Arch Dis Child. 2020 Jul;105(7):671-676. doi: 10.1136/archdischild-2019-317765. Epub 2020 Jan 14.
PubMed 31937567Turner D, Kenigsberg S, Plotkin L, Aharoni-Frutkoff Y, Sokolik M, Focht G, Gasasa S, Turpin W, Waslyk AM, Ledder O, Griffiths AM, Martincevic I, Huynh HQ, Godny L, Avni-Biron I, Torres J, Panaccione R, Jacobson K, Otley A, Sharar-Fischler T, Li Q, Azulay A, Sigall-Boneh R, Lee SH, Croitoru K. TASTY AND HEALTHY DIET REDUCES FECAL CALPROTECTIN IN HIGH-RISK FIRST-DEGREE RELATIVES OF PATIENTS WITH CROHN'S DISEASE: PIONIR RANDOMIZED CROSSOVER TRIAL. Gastroenterology. 2026 Oct 26:S0016-5085(26)07729-2. doi: 10.1053/j.gastro.2026.10.376. Online ahead of print.
PubMed 42933673Birda CL, Jena A, Torres J, Ng SC, Kotze PG, Sebastian S, Sharma V. Road to IBD prevention in the Global South: a conceptual framework modelling from non-communicable diseases. Gut. 2026 Apr 7;75(5):1055-1066. doi: 10.1136/gutjnl-2025-337298.
PubMed 41482459
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing IBD Onset in Individuals at Risk
- ClinicalTrials.gov ID
- NCT05211518
- Acronym / sponsor ID
- PIONIR / PIONIR trial
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Chron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital, The Hospital for Sick Children, The Governors of the University of Alberta, University of Manitoba, IWK Health Centre, University of British Columbia, University of Calgary, McGill University, Beilinson Hospital, Petach Tikva,Israel
- Study start
- 4 May 2021 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 27 Jan 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.
The goal of this study is to explore in a cross over randomized controlled trial, the ability of the Tasty\&Healthy dietary intervention (NCT04239248) to alter the parameters associated with future risk of developing Chron's disease (CD) using First Degree Relatives of patients with Crohn's disease, including subjects identified in the Genetic Environmental Microbiome (GEM) Study as having a high-risk score. Specifically, the investigators aim to determine if the Tasty\&Healthy dietary intervention can decrease the overall GEM Risk Score (GRS) and/or to alter the individual biological parameters that contribute to this score. The investigators hypothesize that the Tasty\&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GRS.
Detailed description
Several important factors associated with CD onset have already been identified in the GEM analyses, such as elevated faecal calprotectin(FC),altered gut permeability, proteomics, anti-microbial serology, and microbiome composition. These parameters are combined into the GEM Risk Score (GRS).
The first-line therapy in children with CD, according to ECCO/ESPGHAN guidelines, is exclusive enteral nutrition (EEN), meaning 8-12 weeks of exclusive liquid formula. Nutritional therapy may alter intestinal inflammation by several mechanisms, including modulation of the microbiome and an effect on intestinal permeability, both factors assessed in the GEM cohort. EEN is safe and effective, but it is challenging to implement.
Several diets, based on solid foods, have been proposed as alternatives to EEN in an attempt to increase feasibility, three of which have the most data.
Specific carbohydrate diet (SCD) restricts carbohydrates and processed foods and has been long used with variable reported effectiveness.
The CD-TREAT diet induced a positive change to the microbiome, children with active CD entered clinical remission with decreased inflammatory markers.
Crohn's Disease Exclusion Diet (CDED) is based on the exclusion of processed and pro-inflammatory foods, similar to Tasty\&Healthy. A recent RCT of CDED diet with 50% liquid formula showed comparable effectiveness as EEN, including normalization of FC and positive effect on the microbiome.
However, the allowed dietary components are not liberal, and the diet is rigid, making it unsuitable as a prevention measure.
In 2014, a cook-book named "Tasty\&Healthy" was published as a simple approach to dietary treatment based on the best available evidence. A steering committee of physicians experienced in IBD and nutrition, as well as leading IBD dieticians, reviewed results of dietary studies from animal models, humans and epidemiological cohorts. This review resulted in agreed-upon foods that may aggravate inflammation and thus should be excluded, including all processed and industrialized food, animal fat (dairy, meat), gluten and sugar. Overall, allowed foods in liberal quantities are those prepared at home from readily available ingredients such as fruits, vegetables, fish and shellfish, poultry, oats, eggs, non-gluten grains and legumes. Tasty\&Healthy is not a specific diet; it is a dietary approach in which the allowed foods are not structured or restricted. This approach allows flexibility to increase adherence In this study, The Investigators hypothesize that the Tasty\&Healthy dietary approach will alter the risk of CD as reflected by a decrease in the GEM CD risk score or alteration of its individual components.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tasty&Healthy | Other | Other: Tasty&HealthyTasty\&Healthy intervention: subjects will receive dietary advice to exclude pro-inflammatory dietary components |
| Habitual diet | Other | Other: Habitual dietHabitual diet: subjects will continue their habitual diet. |
Who may qualify
- Ages
- 6 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinically healthy subjects (i.e. lack of symptoms that may suggest IBD) who are First degree relatives of someone with CD with a high faecal calprotectin (FC)\>70μg/g or subjects who have a risk factor for example elevated GRS. Where available LMR will also be assessed to identify subjects ranked as top 100 at risk of CD.
- Younger than 39 years of age, in order to maximize future risk of developing CD.
- No overt ulcerations (other than aphthous ulcerations) in the ileum or colon. Some degree of inflammation may be seen in these high-risk subjects with increased risk parameters and this does not necessarily prompt the diagnosis of CD. Moreover, in this proof of concept study we would like to have those with the highest risk (hence some degree of initial inflammation) but without macroscopic inflammation that clearly is associated with the diagnosis of CD. Patency capsule and VCE procedure will be performed if the subjects calprotectin levels are \>70μg/g.
Key exclusion criteria (8 listed)
- Ulcerative colitis (UC) or IBD-unclassified (IBDU) diagnosis
- The use of antibiotics in the preceding month
- Prior intestinal resection
- Pregnancy (and up until six months after giving birth)
- Celiac disease or Diabetes
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 |
|---|---|---|
| Tasty&Healthyexclude pro-inflammatory dietary components | Other | Tasty&Healthy |
| Habitual dietsubjects will continue their habitual diet. | Other | Habitual diet |
Primary outcome
Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity.
Time frame: 8 weeks of Tasty&Healthy diet.
Fecal calprotectin (FC) is a validated, sensitive marker of intestinal inflammation and reflects short term biological changes expected from the Tasty \& Healthy intervention. For this reason, the primary endpoint is a reduction in FC over the 8 weeks of the intervention.
9 secondary outcomes
Change in the GEM integrative risk score
Time frame: 8 weeks of Tasty & Healthy intervention
Change in Microbiome risk score (MRS)
Time frame: 8 weeks of Tasty&Healthy diet.
Change in Lactulose-Mannitol Ratio (LMR).
Time frame: 8 weeks of Tasty&Healthy diet.
Change in Serum Metabolomics pre and post-intervention
Time frame: 8 weeks of Tasty&Healthy diet.
Change in Serum Proteomics pre and post-intervention
Time frame: 8 weeks of Tasty&Healthy diet.
Ability to maintain a balanced diet as measured by food diaries.
Time frame: 8 weeks of Tasty&Healthy diet.
Adherence with the interventions, including assessment of faecal gluten.
Time frame: 8 weeks of Tasty&Healthy diet.
Satisfaction with the treatment received, as assessed by the Satisfaction with Food-Related Life (SFRL) questionnaire.
Time frame: 8 weeks of Tasty&Healthy diet.
Change in routine blood biomarkers over the course of the 8 week intervention
Time frame: 8 weeks of Tasty&Healthy intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 33438721Stulman MY, Asayag N, Focht G, Brufman I, Cahan A, Ledderman N, Matz E, Chowers Y, Eliakim R, Ben-Horin S, Odes S, Dotan I, Balicer RD, Benchimol EI, Turner D. Epidemiology of Inflammatory Bowel Diseases in Israel: A Nationwide Epi-Israeli IBD Research Nucleus Study. Inflamm Bowel Dis. 2021 Oct 20;27(11):1784-1794. doi: 10.1093/ibd/izaa341.
- Background: PubMed 33010847Department of Error. Lancet. 2020 Oct 3;396(10256):e56. doi: 10.1016/S0140-6736(20)32028-6. No abstract available.
- Background: PubMed 32002671Beard JA, Franco DL, Click BH. The Burden of Cost in Inflammatory Bowel Disease: A Medical Economic Perspective and the Future of Value-Based Care. Curr Gastroenterol Rep. 2020 Jan 30;22(2):6. doi: 10.1007/s11894-020-0744-z.
- Background: PubMed 31937567Barnes C, Ashton JJ, Borca F, Cullen M, Walker DM, Beattie RM. Children and young people with inflammatory bowel disease attend less school than their healthy peers. Arch Dis Child. 2020 Jul;105(7):671-676. doi: 10.1136/archdischild-2019-317765. Epub 2020 Jan 14.
- Derived from this study: PubMed 42933673Turner D, Kenigsberg S, Plotkin L, Aharoni-Frutkoff Y, Sokolik M, Focht G, Gasasa S, Turpin W, Waslyk AM, Ledder O, Griffiths AM, Martincevic I, Huynh HQ, Godny L, Avni-Biron I, Torres J, Panaccione R, Jacobson K, Otley A, Sharar-Fischler T, Li Q, Azulay A, Sigall-Boneh R, Lee SH, Croitoru K. TASTY AND HEALTHY DIET REDUCES FECAL CALPROTECTIN IN HIGH-RISK FIRST-DEGREE RELATIVES OF PATIENTS WITH CROHN'S DISEASE: PIONIR RANDOMIZED CROSSOVER TRIAL. Gastroenterology. 2026 Oct 26:S0016-5085(26)07729-2. doi: 10.1053/j.gastro.2026.10.376. Online ahead of print.
- Derived from this study: PubMed 41482459Birda CL, Jena A, Torres J, Ng SC, Kotze PG, Sebastian S, Sharma V. Road to IBD prevention in the Global South: a conceptual framework modelling from non-communicable diseases. Gut. 2026 Apr 7;75(5):1055-1066. doi: 10.1136/gutjnl-2025-337298.
- Individual participant dataSharing planned: Undecided
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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.
Dan Turner, Prof principal investigator
Saare Zedek 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 Tasty&Healthy and Habitual diet in people with Inflammatory Bowel Diseases, run by Shaare Zedek 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 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: finished, as of the sponsor's last update on 27 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in fecal calprotectin (FC) levels over the 8 week Tasty & Healthy dietary intervention, reflecting improvement in intestinal inflammatory activity. (time frame: 8 weeks of Tasty&Healthy diet.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211518, which also lists 6 linked publications.
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 27 Mar 2026.