Crohn DiseaseNCT06933264
Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease
A study testing Exclusion diet in people with Crohn Disease, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration of the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Exclusion diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subjects of both sexes over 18 years of age.
- A diagnosis of active luminal CD with small bowel involvement, with or without colonic involvement, prior to study inclusion.
- Active symptoms of CD at the time of initiation of the nutritional intervention.
- Active disease, defined as a Harvey-Bradshaw Index (HBI) > 4 and an objective measure of disease activity, such as an elevated inflammatory marker (CRP > 5 mg/L or 0.5 mg/dL, or calprotectin ≥ 250 µg/g) and/or a radiological imaging test (MR enterography or intestinal ultrasound) or an endoscopic test (ileocolonoscopy or capsule endoscopy).
- Ability and willingness to adhere to one of the nutritional interventions.
- Capacity to complete and sign the informed consent form.
Who cannot join
- Patients experiencing a severe flare that is associated with fistulizing tracts or strictures during the study period.
- Hospitalized patients.
- Patients with known intolerance or hypersensitivity to the components of the nu-tritional supplement Modulen IBD.
- Patients following another diet or who are participating in other nutritional trials.
- Patients scheduled for surgical intervention during the study period.
- Patients with active malignancy.
- Patients undergoing treatment with antibiotics or probiotics.
- Patients with other clinical conditions that may interfere with the implementation of the nutritional interventions (such as heart disease, celiac disease, uncontrolled diabetes, active infections, tuberculosis, or a positive stool test for Clostridium dif-ficile toxin).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
R . Paloma Cano Mármol, Endocrinology and Nutrition contact
Spain1 site
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Rosario Paloma Cano Mármol, Endocrinology and Nutrition, +34 618 35 71 53, palomacanomarmol96@gmail.com
Bruno Ramos Molina, Investigator of IMIB, +34 694 44 77 02, brunoramosmolina@gmail.com
About this study
Official title: Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Adult Patients With Crohn's Disease: Protocol for a Prospective, Interventional, Controlled, Randomized Clinical Trial
Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration of the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota. The analysis of different dietary strategies to achieve CD remission and reduce gastrointestinal symptoms concludes that it is nec-essary to restrict the intake of ultra-processed products and to promote the consump-tion of those with anti-inflammatory effects that improve intestinal permeability and dysbiosis. Based on previous studies conducted in other cohorts, mainly paediatric, we propose an experimental, prospective, randomised study in patients with active CD who do not show improvement with conventional pharmacological treatment. The control group will receive standard nutritional recommendations while the interven-tion group will be prescribed an exclusion diet supplemented with enteral nutrition. In the present project we plan to conduct a detailed study to determine the potential of the exclusion diet for the treatment and remission of CD in adult patients, with the hypothesis that this nutritional intervention will be able to modify and improve intes-tinal dysbiosis, inflammatory status and clinical and body composition markers in these patients.
Read the detailed description
An analysis of various dietary strategies to achieve remission of CD and reduce gastrointestinal symptoms concludes that it is necessary to restrict the intake of ultra-processed products while promoting foods with anti-inflammatory effects that improve intestinal permeability and dysbiosis. The European Society for Clinical Nutrition and Metabolism (ESPEN) acknowledges that there is insufficient evidence to recommend a specific diet and emphasizes the importance of individualization. Current scientific literature supports the use of the exclusion diet (ED) in CD, which is characterized by the exclusion of frozen or packaged foods due to their additive content and the inclusion of fresh, fiber-rich foods-owing to the benefits observed in symptom remission in the pediatric population. However, evidence in adults, although encouraging, remains limited. The ED is supplemented with a specific enteral nutrition formula that should not exceed 1250 Kcal/day and is administered at a proportion of 25-50%, depending on the phase of the diet. The first two phases last 6 weeks each (12 weeks in total) and include foods that must be consumed daily. In the final maintenance phase, starting from week 13, there are no mandatory foods, and a Mediterranean diet is promoted. The literature also advocates for modifying the dietary pattern by reducing ultra-processed foods and adhering to the Mediterranean diet after one year of initiating the ED.
On the other hand, evidence regarding the impact on body composition in patients with CD is scarce and heterogeneous, which justifies further research and the publication of higher-quality data. These findings could present an opportunity to improve the treatment of patients with CD and to incorporate body composition assessment into routine clinical practice.
The primary advantage of this dietary strategy lies in its balanced, sustainable, and palatable nature, making it easier to adhere to over time. This is largely due to its inclusion of dietary fiber and essential substrates necessary for the production of short-chain fatty acids. The exclusion diet is based on the elimination or inclusion of specific dietary components while ensuring a nutrient composition that supports growth and maintenance of lean body mass.
Foods and additives that should be excluded from this diet include those associ-ated with high fat intake (particularly from animal sources, such as red meat), dairy products, wheat, alcohol, yeast, and insoluble fiber. Additionally, food additives recommended for avoidance include emulsifiers, carrageenan, maltodextrins, sulfites, and titanium dioxide. Conversely, the diet should be low in taurine, rich in pro-teins and complex carbohydrates, and free of gluten or modified starches.
- Conditions
- Crohn Disease
- Being tested
- Exclusion diet
- Keywords
- Crohn disease, Gut microbiome, Nutrition, Exclusion diet
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusion dietDietary supplement
Also called Experimental group
Experimental Group: Patients will receive modifications to their pharmacological and will be assigned to an intervention consisting of an exclusion diet in conjunc-tion with supplemental enteral nutrition. This nutritional strategy will involve a progressive increase in the caloric intake derived from the diet, coupled with a corresponding reduction in supplemental enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Exclusion diet | Experimental | Experimental Group: Patients will receive modifications to their pharmacological and will be assigned to an intervention consisting of an exclusion diet in conjunc-tion with supplemental enteral nutrition. This nutritional strategy will involve a progressive increase in the caloric intake derived from the diet, coupled with a corresponding reduction in supplemental enteral nutrition. Receives: Dietary Supplement: Exclusion diet |
| Mediterranean diet | No intervention | Control Group: Patients will receive modifications to their pharmacological treatment alongside standard nutritional recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
The primary objective of this clinical study is to determine the effectiveness and impact on body composition of implementing an exclusion diet for symptomatic remission in adult patients with active Crohn disease.
Measured: From enrollment to the end of study at 24 weeks
Secondary outcomes (12)
Inflamatory parameters
Inflammatory parameters in blood: C-reactive protein (mg/dl)
Measured: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Inflammatory parameters in blood: Inflammatory parameters in blood: erythrocyte sedimentation rate (mm/h)
Measured: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Inflammatory parameters in blood: Interleukin 6 (pg/ml)
Measured: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Inflammatory parameters in stool: fecal calprotectin (µg/g)
Measured: From enrollment to the end of study at 24 weeks
Clinical parameters
Clinical parameters: gastrointestinal symptoms (abdominal pain: YES/NO; rectal tenesmus: YES/NO; defecatory urge: YES/NO)
Measured: From enrollment to the end of study at 24 weeks
Clinical parameters
Clinical parameters: number and consistency of stools
Measured: From enrollment to the end of study at 24 weeks
Clinical parameters
Clinical parameters: fever (YES/NO), extraintestinal manifestations (YES/NO)
Measured: From enrollment to the end of study at 24 weeks
Sarcopenia
Functional tests (SPPB, measure in seconds)
Measured: From enrollment to the end of study at 24 weeks
Sarcopenia
Dynamometry (kg).
Measured: From enrollment to the end of study at 24 weeks
Quality of live and disease remission
To determine the rate of improvement in the quality of life of patients with using the CVEII9 quality of life.
Measured: From enrollment to the end of study at 24 weeks
Quality of live and disease remission
To determine the rate of the disease remission by evaluating the Crohn's Disease Activity Index (Harvey-Bradshaw Index).
Measured: From enrollment to the end of study at 24 weeks
Intestinal microbiota
To analyze the modifications in the intestinal microbiota resulting from the im-plementation of the ED.
Measured: From enrollment to the end of study at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia, Sociedad Española de Endocrinología y Nutrición, Instituto Murciano de Investigación Biosanitaria (IMIB)
- Responsible party
- Principal investigator, Rosario Paloma Cano Mármol, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Bruno Ramos Molina, Investigator of IMIB, Study director, Instituto Murciano de Investigación Biosanitaria (IMIB)Antonio J. Ruiz Alcaraz, Investigator of IMIB, Study director, Instituto Murciano de Investigación Biosanitaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933264
- Sponsor's protocol ID
- 2022-4-10-HCUVA
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Adult Patients With Crohn's Disease: Protocol for a Prospective, Interventional, Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06933264
- Acronym / sponsor ID
- 2022-4-10-HCUVA
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, Gut microbiome, Nutrition, Exclusion diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Collaborators
- Universidad de Murcia, Sociedad Española de Endocrinología y Nutrición, Instituto Murciano de Investigación Biosanitaria (IMIB)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Apr 2025 (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.
Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration of the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota. The analysis of different dietary strategies to achieve CD remission and reduce gastrointestinal symptoms concludes that it is nec-essary to restrict the intake of ultra-processed products and to promote the consump-tion of those with anti-inflammatory effects that improve intestinal permeability and dysbiosis. Based on previous studies conducted in other cohorts, mainly paediatric, we propose an experimental, prospective, randomised study in patients with active CD who do not show improvement with conventional pharmacological treatment. The control group will receive standard nutritional recommendations while the interven-tion group will be prescribed an exclusion diet supplemented with enteral nutrition. In the present project we plan to conduct a detailed study to determine the potential of the exclusion diet for the treatment and remission of CD in adult patients, with the hypothesis that this nutritional intervention will be able to modify and improve intes-tinal dysbiosis, inflammatory status and clinical and body composition markers in these patients.
Detailed description
An analysis of various dietary strategies to achieve remission of CD and reduce gastrointestinal symptoms concludes that it is necessary to restrict the intake of ultra-processed products while promoting foods with anti-inflammatory effects that improve intestinal permeability and dysbiosis. The European Society for Clinical Nutrition and Metabolism (ESPEN) acknowledges that there is insufficient evidence to recommend a specific diet and emphasizes the importance of individualization. Current scientific literature supports the use of the exclusion diet (ED) in CD, which is characterized by the exclusion of frozen or packaged foods due to their additive content and the inclusion of fresh, fiber-rich foods-owing to the benefits observed in symptom remission in the pediatric population. However, evidence in adults, although encouraging, remains limited. The ED is supplemented with a specific enteral nutrition formula that should not exceed 1250 Kcal/day and is administered at a proportion of 25-50%, depending on the phase of the diet. The first two phases last 6 weeks each (12 weeks in total) and include foods that must be consumed daily. In the final maintenance phase, starting from week 13, there are no mandatory foods, and a Mediterranean diet is promoted. The literature also advocates for modifying the dietary pattern by reducing ultra-processed foods and adhering to the Mediterranean diet after one year of initiating the ED.
On the other hand, evidence regarding the impact on body composition in patients with CD is scarce and heterogeneous, which justifies further research and the publication of higher-quality data. These findings could present an opportunity to improve the treatment of patients with CD and to incorporate body composition assessment into routine clinical practice.
The primary advantage of this dietary strategy lies in its balanced, sustainable, and palatable nature, making it easier to adhere to over time. This is largely due to its inclusion of dietary fiber and essential substrates necessary for the production of short-chain fatty acids. The exclusion diet is based on the elimination or inclusion of specific dietary components while ensuring a nutrient composition that supports growth and maintenance of lean body mass.
Foods and additives that should be excluded from this diet include those associ-ated with high fat intake (particularly from animal sources, such as red meat), dairy products, wheat, alcohol, yeast, and insoluble fiber. Additionally, food additives recommended for avoidance include emulsifiers, carrageenan, maltodextrins, sulfites, and titanium dioxide. Conversely, the diet should be low in taurine, rich in pro-teins and complex carbohydrates, and free of gluten or modified starches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusion diet | Experimental | Dietary Supplement: Exclusion dietExperimental Group: Patients will receive modifications to their pharmacological and will be assigned to an intervention consisting of an exclusion diet in conjunc-tion with supplemental enteral nutrition. This nutritional strategy will involve a progressive increase in the caloric intake derived from the diet, coupled with a corresponding reduction in supplemental enteral nutrition. |
| Mediterranean diet | No intervention | –Control Group: Patients will receive modifications to their pharmacological treatment alongside standard nutritional recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects of both sexes over 18 years of age.
- A diagnosis of active luminal CD with small bowel involvement, with or without colonic involvement, prior to study inclusion.
- Active symptoms of CD at the time of initiation of the nutritional intervention.
- Active disease, defined as a Harvey-Bradshaw Index (HBI) > 4 and an objective measure of disease activity, such as an elevated inflammatory marker (CRP > 5 mg/L or 0.5 mg/dL, or calprotectin ≥ 250 µg/g) and/or a radiological imaging test (MR enterography or intestinal ultrasound) or an endoscopic test (ileocolonoscopy or capsule endoscopy).
- Ability and willingness to adhere to one of the nutritional interventions.
Key exclusion criteria (8 listed)
- Patients experiencing a severe flare that is associated with fistulizing tracts or strictures during the study period.
- Hospitalized patients.
- Patients with known intolerance or hypersensitivity to the components of the nu-tritional supplement Modulen IBD.
- Patients following another diet or who are participating in other nutritional trials.
- Patients scheduled for surgical intervention during the study period.
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 |
|---|---|---|
| Exclusion dietAlso: Experimental groupExperimental Group: Patients will receive modifications to their pharmacological and will be assigned to an intervention consisting of an exclusion diet in conjunc-tion with supplemental enteral nutrition. This nutritional strategy will involve a progressive increase in the caloric intake derived from the diet, coupled with a corresponding reduction in supplemental enteral nutrition. | Dietary supplement | Exclusion diet |
Primary outcome
Body composition
Time frame: From enrollment to the end of study at 24 weeks
The primary objective of this clinical study is to determine the effectiveness and impact on body composition of implementing an exclusion diet for symptomatic remission in adult patients with active Crohn disease.
12 secondary outcomes
Inflamatory parameters
Time frame: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Time frame: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Time frame: From enrollment to the end of study at 24 weeks
Inflamatory parameters
Time frame: From enrollment to the end of study at 24 weeks
Clinical parameters
Time frame: From enrollment to the end of study at 24 weeks
Clinical parameters
Time frame: From enrollment to the end of study at 24 weeks
Clinical parameters
Time frame: From enrollment to the end of study at 24 weeks
Sarcopenia
Time frame: From enrollment to the end of study at 24 weeks
Sarcopenia
Time frame: From enrollment to the end of study at 24 weeks
Quality of live and disease remission
Time frame: From enrollment to the end of study at 24 weeks
Quality of live and disease remission
Time frame: From enrollment to the end of study at 24 weeks
Intestinal microbiota
Time frame: From enrollment to the end of study at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- 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.
R . Paloma Cano Mármol, Endocrinology and Nutrition contact
Bruno Ramos Molina, Investigator of IMIB study director
Instituto Murciano de Investigación Biosanitaria (IMIB)
Antonio J. Ruiz Alcaraz, Investigator of IMIB study director
Instituto Murciano de Investigación Biosanitaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusion diet in people with Crohn Disease, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 6 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: opening soon, as of the sponsor's last update on 18 Apr 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R . Paloma Cano Mármol, Endocrinology and Nutrition (+ 34 618 35 71 53, palomacanomarmol96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: From enrollment to the end of study at 24 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 18 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.