Crohn DiseaseREVIDECNCT07211789
Real World Evidence Study With Restrictive Diet and Otral Nutritional Supplementation on Pediatric Patients With Active Chron Disease
An observational study of Crohn Disease, run by Outcomes'10 at 15 sites in Spain.
Trial summary
This prospective study aims to provide real-world evidence of the effectiveness of the NEP + CDED diet in paediatric patients with Crohn's disease under conditions of routine clinical practice. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Crohn Disease
- How many people
- 58 participants
- Where
- 15 sitesSpain
- Study dates
- 1 Feb 2024to 15 Aug 2025
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 8-18 years with Crohn's disease initiating treatment with exclusive enteral nutrition (EEN) plus the Crohn's Disease Exclusion Diet (CDED) and whose wPCDAI value is equal to or greater than 12.5.
Who may be able to join
- Patients with Crohn's disease (diagnosis based on clinical, laboratory, endoscopic, radiological, and histological criteria, according to the revised Porto criteria of the ESPGHAN for the diagnosis of inflammatory bowel disease in children and adolescents);
- Aged between 8 and 18 years;
- Who are about to start treatment with NEP + CDED, i.e. CDED-naive patients who may have previously received treatment with NEE;
- With active Crohn's disease defined by the Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) ≥ 12.5;
- With data collection available for the following 6 months;
- Able to follow the study protocol or whose parent/caregiver is able to adhere to the study protocol, according to the investigator's perspective.
Who cannot join
- Patients with ulcerative colitis and/or unclassified inflammatory bowel disease.
- Patients with more than 36 months of disease progression.
- Penetrating (B3) and/or non-inflammatory stenosing (B2) pattern.
- Active perianal disease.
- Presence of extraintestinal manifestations.
- Patients who, in the investigator's opinion, will require surgical treatment or initiation of steroids or biological drugs (anti-TNF, vedolizumab or ustekinumab) within the next 3 months and for whom nutritional support is indicated exclusively as a bridge. Patients who are undergoing biological treatment but discontinue treatment due to non-response and initiate CDED+NEP are not excluded.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital Torrecárdenas
Almería
Hospital Sant Joan de Déu
Barcelona
Hospital Univeristari Vall d'Hebron
Barcelona
Hospital Universitario Virgen de la Arrixaca
El Palmar
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario Materno-Infantil de Canarias de Las Palmas
Las Palmas de Gran Canaria
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Niño Jesús
Madrid
Hospital Universitario Materno Infantil
Málaga
Hospital Universitario Central
Oviedo
Hospital Universitario de Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario la Fe
Valencia
About this study
Official title: Real World Evidence en Pacientes pediátricos Con Enfermedad de Crohn Activa
This prospective study aims to provide real-world evidence of the effectiveness of the NEP + CDED diet in paediatric patients with Crohn's disease under conditions of routine clinical practice.
Read the detailed description
Pediatric Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract that impacts growth and quality of life. Exclusive enteral nutrition (EEN) is the standard dietary treatment to induce remission, although its use is limited by low acceptability and strict dietary restrictions.
The combination of partial enteral nutrition (PEN) with the Crohn's Disease Exclusion Diet (CDED) represents a more tolerable alternative that reduces exposure to harmful dietary components and has shown efficacy in inducing clinical remission in previous studies.
This observational, prospective, multicenter study will evaluate the effectiveness of CDED+PEN in routine clinical practice in pediatric patients (8-18 years) with active Crohn's disease. The primary objective is to assess the proportion of patients achieving clinical remission (wPCDAI ≤ 12.5) and mucosal healing (MINI Index < 8), steroid-free at weeks 6, 12, and 24, and anti-TNF-free at week 24.
Secondary objectives include assessing health-related quality of life (IMPACT-III), treatment satisfaction and gastrointestinal tolerance, treatment persistence, and estimation of healthcare resource utilization and associated costs. The study is observational, descriptive, and non-interventional with respect to drugs, and will be conducted in pediatric patients initiating CDED+PEN as part of standard clinical care. Treatment prescription will be independent of study participation, and patients who receive the indication may be invited to participate after providing informed consent together with their parents or legal guardians.
Primary outcome measures include the frequency of patients in steroid-free clinical remission at weeks 6, 12, and 24, anti-TNF-free remission at week 24, and the proportion achieving mucosal healing (MINI Index < 8) at the same time points. Secondary analyses will include quality of life scores (IMPACT-III), distribution of questionnaire responses on satisfaction and tolerance, treatment persistence assessed by survival analysis, and cost estimates based on healthcare resource use.
This study will provide real-world evidence on the effectiveness, acceptability, and sustainability of the dietary approach with CDED+PEN in pediatric Crohn's disease under routine clinical practice conditions.
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease, Pediatric Crohn's Disease, Children, Pediatrics, Observational Study, Multicenter Study, Prospective Study, Quality of Life, exclusion diet, wPCDAI, MINI index
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Pediatric Crohn's 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 |
|---|---|---|
| Patients aged 8-18 years with Crohn's disease initiating treatment with EEN+CDED | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the CDED + NEP
Measurement of absolute and relative frequencies of patients in steroid-free remission
Measured: Weeks 6, 12, 24
Effectiveness of the CDED + NEP
Measurement of absolute and relative frequencies of patients in anti-TNF-free remission
Measured: At week 24
Mucosal healing
The relative and absolute frequencies of patients who have obtained a score of <8 on the MINI Index will be calculated; this value implies healing of the mucosa.
Measured: Weeks 6, 12, 24
Secondary outcomes (5)
Health-related quality of life
The scores obtained with the HRQoL questionnaire will be calculated
Measured: Weeks 6, 12, 24
Satisfaction and acceptability with nutritional treatment
Based on the distribution of responses to the questionnaire items
Measured: Weeks 6, 12, 24
Gastrointestinal tolerance
Distribution of responses to questionnaire items
Measured: Weeks 6, 12, 24
Persistence with the diet
Percentage of patients who persist with the diet at
Measured: Weeks 6, 12, 24
Healthcare resource use and associated costs
It will be calculated:
- Number of visits to professionals who treat the patient (specialist in gastroenterology and paediatric nutrition, primary care, nursing, educational psychologist, social worker, dietitian/nutritionist)
- Number of visits to the emergency room per month,
- Number of days hospitalised per month,
- Number of complementary tests per month,
- Number of days of sick leave taken by the caregiver per month,
- Number of school days missed per month.
For each patient, the monthly cost associated with the use of resources will be estimated by multiplying the frequency of use per month of each resource by its unit cost. Unit costs will be extracted from eSalud.
Measured: Weeks 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Feb 2024
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outcomes'10
- Sponsor type
- Research network
- Collaborators
- Nestlé Health Science Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211789
- Sponsor's protocol ID
- NES-2019-050-OBS-CROHN
- Acronym
- REVIDEC
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence en Pacientes pediátricos Con Enfermedad de Crohn Activa
- ClinicalTrials.gov ID
- NCT07211789
- Acronym / sponsor ID
- REVIDEC / NES-2019-050-OBS-CROHN
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease, Pediatric Crohn's Disease, Children, Pediatrics, Observational Study, Multicenter Study, Prospective Study, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Outcomes'10Research network
- Collaborators
- Nestlé Health Science Spain
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 8 Oct 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.
This prospective study aims to provide real-world evidence of the effectiveness of the NEP + CDED diet in paediatric patients with Crohn's disease under conditions of routine clinical practice.
Detailed description
Pediatric Crohn's disease is a chronic inflammatory disorder of the gastrointestinal tract that impacts growth and quality of life. Exclusive enteral nutrition (EEN) is the standard dietary treatment to induce remission, although its use is limited by low acceptability and strict dietary restrictions.
The combination of partial enteral nutrition (PEN) with the Crohn's Disease Exclusion Diet (CDED) represents a more tolerable alternative that reduces exposure to harmful dietary components and has shown efficacy in inducing clinical remission in previous studies.
This observational, prospective, multicenter study will evaluate the effectiveness of CDED+PEN in routine clinical practice in pediatric patients (8-18 years) with active Crohn's disease. The primary objective is to assess the proportion of patients achieving clinical remission (wPCDAI ≤ 12.5) and mucosal healing (MINI Index < 8), steroid-free at weeks 6, 12, and 24, and anti-TNF-free at week 24.
Secondary objectives include assessing health-related quality of life (IMPACT-III), treatment satisfaction and gastrointestinal tolerance, treatment persistence, and estimation of healthcare resource utilization and associated costs. The study is observational, descriptive, and non-interventional with respect to drugs, and will be conducted in pediatric patients initiating CDED+PEN as part of standard clinical care. Treatment prescription will be independent of study participation, and patients who receive the indication may be invited to participate after providing informed consent together with their parents or legal guardians.
Primary outcome measures include the frequency of patients in steroid-free clinical remission at weeks 6, 12, and 24, anti-TNF-free remission at week 24, and the proportion achieving mucosal healing (MINI Index < 8) at the same time points. Secondary analyses will include quality of life scores (IMPACT-III), distribution of questionnaire responses on satisfaction and tolerance, treatment persistence assessed by survival analysis, and cost estimates based on healthcare resource use.
This study will provide real-world evidence on the effectiveness, acceptability, and sustainability of the dietary approach with CDED+PEN in pediatric Crohn's disease under routine clinical practice conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 8-18 years with Crohn's disease initiating treatment with EEN+CDED | – | – |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 8-18 years with Crohn's disease initiating treatment with exclusive enteral nutrition (EEN) plus the Crohn's Disease Exclusion Diet (CDED) and whose wPCDAI value is equal to or greater than 12.5.
Key inclusion criteria (6 listed)
- Patients with Crohn's disease (diagnosis based on clinical, laboratory, endoscopic, radiological, and histological criteria, according to the revised Porto criteria of the ESPGHAN for the diagnosis of inflammatory bowel disease in children and adolescents);
- Aged between 8 and 18 years;
- Who are about to start treatment with NEP + CDED, i.e. CDED-naive patients who may have previously received treatment with NEE;
- With active Crohn's disease defined by the Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) ≥ 12.5;
- With data collection available for the following 6 months;
Key exclusion criteria (6 listed)
- Patients with ulcerative colitis and/or unclassified inflammatory bowel disease.
- Patients with more than 36 months of disease progression.
- Penetrating (B3) and/or non-inflammatory stenosing (B2) pattern.
- Active perianal disease.
- Presence of extraintestinal manifestations.
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
Effectiveness of the CDED + NEP
Time frame: Weeks 6, 12, 24
Measurement of absolute and relative frequencies of patients in steroid-free remission
Effectiveness of the CDED + NEP
Time frame: At week 24
Measurement of absolute and relative frequencies of patients in anti-TNF-free remission
Mucosal healing
Time frame: Weeks 6, 12, 24
The relative and absolute frequencies of patients who have obtained a score of <8 on the MINI Index will be calculated; this value implies healing of the mucosa.
5 secondary outcomes
Health-related quality of life
Time frame: Weeks 6, 12, 24
Satisfaction and acceptability with nutritional treatment
Time frame: Weeks 6, 12, 24
Gastrointestinal tolerance
Time frame: Weeks 6, 12, 24
Persistence with the diet
Time frame: Weeks 6, 12, 24
Healthcare resource use and associated costs
Time frame: Weeks 6, 12, 24
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 8 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Crohn 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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 Outcomes'10 at 15 sites 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 6 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
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?
Effectiveness of the CDED + NEP (time frame: Weeks 6, 12, 24). 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 8 Oct 2025.