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Not yet recruitingNCT06353633Updated Apr 9, 2024

The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease

An interventional study of formula and exclusion diet in Inflammatory Bowel Diseases, sponsored by National Nutrition and Food Technology Institute. Not yet recruiting. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
4 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Bowel Diseases

Keywords

  • PEN
03

In context

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.

This study's planned enrollment of 44 is below the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • children aged 4 to 18 years with active Crohn's disease
  • Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40

Exclusion criteria

Exclusion Criteria:

  • Patients who receiving concurrent remission-inducing drugs such as , 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    exclusion diet along with formula

    Dietary Supplement: formula · Behavioral: exclusion diet

  • Active comparator
    A group that receives only exclusion diet

    Behavioral: exclusion diet

Interventions

  • Dietary supplementformula

    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

  • Behavioralexclusion diet

    In this group, only the elimination diet is considered as an intervention

06

What researchers measure

Primary outcomes

  1. PCDAI

    pediatric chron disease activity index

    Time frame: 8 weeks

  2. CRP

    c-reactive protein

    Time frame: 8 weeks

  3. ESR

    erythrocyte sedimentation rate

    Time frame: 8 weeks

  4. FC

    fecal calprotectin

    Time frame: 8 weeks

  5. Alb

    serum albumin

    Time frame: 8 weeks

Secondary outcomes

  1. Arm Circumferance

    the circumference of the arm

    Time frame: 8 weeks

  2. BMI

    body mass index

    Time frame: 8 weeks

  3. Height

    height measurement

    Time frame: 8 weeks

  4. weight

    body weight

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2024; primary completion for Oct 2024, 6 months later.

Of 282 non-industry interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 50. This study's planned 6 months is below that.

Counting every sponsor, half of 296 studies reached it within 27 months; a quarter within 14 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2024
First posted
Apr 9, 2024
StartEst.
Apr 10, 2024
Primary completionEst.
Oct 20, 2024
CompletionEst.
Dec 25, 2024
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06353633
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Principal Investigator, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Apr 9, 2024
Start date
Apr 10, 2024 (estimated)
Primary completion
Oct 20, 2024 (estimated)
Completion
Dec 25, 2024 (estimated)
Last update
Apr 9, 2024

Study contacts

Azita Hekmatdoost, MD, PhD
Contact
a_hekmat2000@yahoo.com
09123065084
Azita Hekmatdoost, MD, PhD
study director · NNFTRI

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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