Inflammatory Bowel DiseasesNCT06353633
The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
A study testing formula and exclusion diet in people with Inflammatory Bowel Diseases, run by National Nutrition and Food Technology Institute.
Trial summary
In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- formula and exclusion diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2024to 25 Dec 2024
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children aged 4 to 18 years with active Crohn's disease
- Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40
Who cannot join
- Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
Trial locations and contacts
No sites are listed yet.
About this study
In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- formula, exclusion diet
- Keywords
- PEN
- 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.
formulaDietary supplement
The calories needed by the person are calculated and half of the calories are provided by formulas and the other half based on the elimination diet
exclusion dietBehavioural
In this group, only the elimination diet is considered as an intervention
| Study group | Role | What they receive |
|---|---|---|
| exclusion diet along with formula | Active comparator | Not described Receives: Dietary Supplement: formula; Behavioral: exclusion diet |
| A group that receives only exclusion diet | Active comparator | Not described Receives: Behavioral: exclusion diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCDAI
pediatric chron disease activity index
Measured: 8 weeks
CRP
c-reactive protein
Measured: 8 weeks
ESR
erythrocyte sedimentation rate
Measured: 8 weeks
FC
fecal calprotectin
Measured: 8 weeks
Alb
serum albumin
Measured: 8 weeks
Secondary outcomes (4)
Arm Circumferance
the circumference of the arm
Measured: 8 weeks
BMI
body mass index
Measured: 8 weeks
Height
height measurement
Measured: 8 weeks
weight
body weight
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start10 Apr 2024 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Azita Hekmatdoost, MD, PhD, Study director, NNFTRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353633
- Sponsor's protocol ID
- AHekmatdoost
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shaygantabar M, Dianati Z, Ledari SM, Sohouli MH, Rohani P, Hekmatdoost A. Exclusion diet vs. exclusion diet plus partial enteral nutrition in management of pediatric Crohn's disease. BMC Pediatr. 2026 Jun 2. doi: 10.1186/s12887-026-07067-z. Online ahead of print.
PubMed 42231250
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06353633
- Acronym / sponsor ID
- AHekmatdoost
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- PEN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 10 Apr 2024 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exclusion diet along with formula | Active comparator | Dietary Supplement: formula, Behavioral: exclusion diet |
| A group that receives only exclusion diet | Active comparator | Behavioral: exclusion diet |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children aged 4 to 18 years with active Crohn's disease
- Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40
Key exclusion criteria (1 listed)
- Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
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 |
|---|---|---|
| formulaThe calories needed by the person are calculated and half of the calories are provided by formulas and the other half based on the elimination diet | Dietary supplement | exclusion diet along with formula |
| exclusion dietIn this group, only the elimination diet is considered as an intervention | Behavioural | A group that receives only exclusion diet, exclusion diet along with formula |
Primary outcome
PCDAI
Time frame: 8 weeks
pediatric chron disease activity index
CRP
Time frame: 8 weeks
c-reactive protein
ESR
Time frame: 8 weeks
erythrocyte sedimentation rate
FC
Time frame: 8 weeks
fecal calprotectin
Alb
Time frame: 8 weeks
serum albumin
4 secondary outcomes
Arm Circumferance
Time frame: 8 weeks
BMI
Time frame: 8 weeks
Height
Time frame: 8 weeks
weight
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 42231250Shaygantabar M, Dianati Z, Ledari SM, Sohouli MH, Rohani P, Hekmatdoost A. Exclusion diet vs. exclusion diet plus partial enteral nutrition in management of pediatric Crohn's disease. BMC Pediatr. 2026 Jun 2. doi: 10.1186/s12887-026-07067-z. Online ahead of print.
- 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.
Azita Hekmatdoost, MD, PhD study director
NNFTRI
Questions about this trial
What is this clinical trial studying?
A study testing formula and exclusion diet in people with Inflammatory Bowel Diseases, run by National Nutrition and Food Technology Institute.
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 2 inclusion and 1 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 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azita Hekmatdoost, MD, PhD (09123065084, a_hekmat2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCDAI (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 NCT06353633, which also lists 1 linked publication.
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 9 Apr 2024.