Crohn DiseaseNCT07821645
Modulen IBD for Induction and Maintenance of Remission in Pediatric Crohn's Disease
An observational study of Crohn Disease and Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
This prospective cohort study aims to evaluate the effectiveness of the specially prepared medical milk formula (Modulen IBD) in inducing and maintaining remission in children and adolescents with Crohn's disease at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Pediatric Crohns Disease
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 20 Jan 2028
- Phase
- Observational
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease attending the Pediatric Gastroenterology, Hepatology and Clinical Nutrition Unit at Assiut University Children Hospital.
Who may be able to join
- - Age younger than 18 years
- Diagnosis of Crohn's disease according to clinical, endoscopic, histopathological, and radiological findings
- Mild to moderate active Crohn's disease
- Newly diagnosed or active patients commencing Exclusive Enteral Nutrition therapy
- Written informed consent from parents or legal guardians
Who cannot join
- - Age 18 years or older
- Severe complicated Crohn's disease requiring immediate surgery
- Other chronic gastrointestinal diseases
- Severe systemic illnesses affecting nutritional status
- Inability to tolerate enteral nutrition
- Poor compliance with Modulen therapy
- Incomplete follow-up data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease
This prospective cohort study aims to evaluate the effectiveness of the specially prepared medical milk formula (Modulen IBD) in inducing and maintaining remission in children and adolescents with Crohn's disease at Assiut University Children Hospital.
Read the detailed description
Exclusive Enteral Nutrition (EEN) is recommended as first-line therapy for induction of remission in mild-to-moderate pediatric Crohn's disease. Modulen IBD is a polymeric formula enriched with TGF-β2.
This observational study will include children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease. Patients receiving Modulen IBD for Exclusive Enteral Nutrition followed by Partial Enteral Nutrition will be compared with those not receiving the formula. Clinical remission, nutritional status, growth parameters, and laboratory markers will be assessed at predefined time points up to 12 months.
- Keywords
- Modulen IBD, Exclusive enteral nutrition, Pediatric Crohn's disease, PCDAI, Remission
- 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 |
|---|---|---|
| Modulen group | Children with Crohn's disease receiving Exclusive Enteral Nutrition followed by Partial Enteral Nutrition with Modulen IBD. | |
| Non-Modulen group | Children with Crohn's disease not receiving Modulen IBD formula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate after exclusive enteral nutrition
Proportion of patients achieving clinical remission defined as Pediatric Crohn's Disease Activity Index (PCDAI) score less than 10 after 6-8 weeks of Exclusive Enteral Nutrition with Modulen IBD.
Measured: At week 6-8
Secondary outcomes (5)
Maintenance of remission
Proportion of patients remaining in clinical remission (PCDAI <10) at 6 months and 12 months
Measured: At 6 months and at 12 months
Change in weight
Change in body weight (kg) from baseline.
Measured: From baseline to week 6-8, 6 months, and 12 months
Change in BMI z-score
Change in Body Mass Index z-score from baseline.
Measured: From baseline to week 6-8, 6 months, and 12 months
Change in inflammatory markers
Change in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels from baseline.
Measured: From baseline to week 6-8, 6 months, and 12 months
Relapse rate
Proportion of patients experiencing clinical relapse (PCDAI ≥10) during follow-up.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MartinaEmad, Assiut University
- Investigators
- Osama m El-Asheer, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821645
- Sponsor's protocol ID
- Modulen-Pediatric-CD-Assiut-20
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trivedi PH, Gadhawe J, Salvi SM, Dodia SM, Pawar D, Patil AS. Stage-specific GWAS identifies a pleiotropic ankyrin repeat locus near GmSALT3 for salinity tolerance in soybean. Plant Cell Rep. 2026 Mar 16;45(4):93. doi: 10.1007/s00299-026-03779-9.
PubMed 41838183Zhu X, Chen M, Dong Z, Liu Y, Mu Q, Basit F, Liu J, Hu J, Guan Y. Stress-associated protein OsSAP5 regulates rice heading date through interacting with OsGF14c in rice. Front Plant Sci. 2025 Sep 9;16:1589989. doi: 10.3389/fpls.2025.1589989. eCollection 2025.
PubMed 40994998van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-Lopez VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021 Feb 1;15(2):jjaa161. doi: 10.1093/ecco-jcc/jjaa161. Epub 2020 Oct 7.
PubMed 33026087Kaspi E, Frankel D, Roll P. Lipid inclusions accumulation in macrophages from peritoneal effusion of a newborn. EJHaem. 2020 Oct 27;1(2):392-393. doi: 10.1002/jha2.124. eCollection 2020 Nov. No abstract available.
PubMed 35845013Brindicci VF, Grieco R, Ruiz RG, Cardile S, Capriati T, Trovato CM, Bolasco G, Knafelz D, Bracci F, Alterio A, Ferretti F, Elia D, Spinetti E, Francavilla R, Diamanti A. Enteral Nutrition in Pediatric Crohn's Disease: New Perspectives. Nutrients. 2025 Sep 30;17(19):3124. doi: 10.3390/nu17193124.
PubMed 41097201
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Specially Prepared Medical Milk Formula for Induction and Maintenance of Remission in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT07821645
- Acronym / sponsor ID
- Modulen-Pediatric-CD-Assiut-20
- Keywords
- Modulen IBD, Exclusive enteral nutrition, Pediatric Crohn's disease, PCDAI, Remission
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 16 Sep 2026 (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 cohort study aims to evaluate the effectiveness of the specially prepared medical milk formula (Modulen IBD) in inducing and maintaining remission in children and adolescents with Crohn's disease at Assiut University Children Hospital.
Detailed description
Exclusive Enteral Nutrition (EEN) is recommended as first-line therapy for induction of remission in mild-to-moderate pediatric Crohn's disease. Modulen IBD is a polymeric formula enriched with TGF-β2.
This observational study will include children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease. Patients receiving Modulen IBD for Exclusive Enteral Nutrition followed by Partial Enteral Nutrition will be compared with those not receiving the formula. Clinical remission, nutritional status, growth parameters, and laboratory markers will be assessed at predefined time points up to 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modulen group | – | –Children with Crohn's disease receiving Exclusive Enteral Nutrition followed by Partial Enteral Nutrition with Modulen IBD. |
| Non-Modulen group | – | –Children with Crohn's disease not receiving Modulen IBD formula. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents younger than 18 years with mild-to-moderate active Crohn's disease attending the Pediatric Gastroenterology, Hepatology and Clinical Nutrition Unit at Assiut University Children Hospital.
Key inclusion criteria (5 listed)
- - Age younger than 18 years
- Diagnosis of Crohn's disease according to clinical, endoscopic, histopathological, and radiological findings
- Mild to moderate active Crohn's disease
- Newly diagnosed or active patients commencing Exclusive Enteral Nutrition therapy
- Written informed consent from parents or legal guardians
Key exclusion criteria (7 listed)
- - Age 18 years or older
- Severe complicated Crohn's disease requiring immediate surgery
- Other chronic gastrointestinal diseases
- Severe systemic illnesses affecting nutritional status
- Inability to tolerate enteral nutrition
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 rate after exclusive enteral nutrition
Time frame: At week 6-8
Proportion of patients achieving clinical remission defined as Pediatric Crohn's Disease Activity Index (PCDAI) score less than 10 after 6-8 weeks of Exclusive Enteral Nutrition with Modulen IBD.
5 secondary outcomes
Maintenance of remission
Time frame: At 6 months and at 12 months
Change in weight
Time frame: From baseline to week 6-8, 6 months, and 12 months
Change in BMI z-score
Time frame: From baseline to week 6-8, 6 months, and 12 months
Change in inflammatory markers
Time frame: From baseline to week 6-8, 6 months, and 12 months
Relapse rate
Time frame: Up to 12 months
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 16 Sep 2026.
- Background: PubMed 41838183Trivedi PH, Gadhawe J, Salvi SM, Dodia SM, Pawar D, Patil AS. Stage-specific GWAS identifies a pleiotropic ankyrin repeat locus near GmSALT3 for salinity tolerance in soybean. Plant Cell Rep. 2026 Mar 16;45(4):93. doi: 10.1007/s00299-026-03779-9.
- Background: PubMed 40994998Zhu X, Chen M, Dong Z, Liu Y, Mu Q, Basit F, Liu J, Hu J, Guan Y. Stress-associated protein OsSAP5 regulates rice heading date through interacting with OsGF14c in rice. Front Plant Sci. 2025 Sep 9;16:1589989. doi: 10.3389/fpls.2025.1589989. eCollection 2025.
- Background: PubMed 33026087van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-Lopez VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021 Feb 1;15(2):jjaa161. doi: 10.1093/ecco-jcc/jjaa161. Epub 2020 Oct 7.
- Background: PubMed 35845013Kaspi E, Frankel D, Roll P. Lipid inclusions accumulation in macrophages from peritoneal effusion of a newborn. EJHaem. 2020 Oct 27;1(2):392-393. doi: 10.1002/jha2.124. eCollection 2020 Nov. No abstract available.
- Background: PubMed 41097201Brindicci VF, Grieco R, Ruiz RG, Cardile S, Capriati T, Trovato CM, Bolasco G, Knafelz D, Bracci F, Alterio A, Ferretti F, Elia D, Spinetti E, Francavilla R, Diamanti A. Enteral Nutrition in Pediatric Crohn's Disease: New Perspectives. Nutrients. 2025 Sep 30;17(19):3124. doi: 10.3390/nu17193124.
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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.
Osama m El-Asheer, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Inflammatory Bowel Diseases, run by Assiut University.
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 5 inclusion and 7 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Martina e Anwer, Resident (01229046462, martinaemad955@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate after exclusive enteral nutrition (time frame: At week 6-8). 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 NCT07821645, which also lists 5 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 16 Sep 2026.