Crohn's DiseaseNCT05034458
Diet in Pediatric Crohn´s Disease Treated With Biologics
A study testing Crohn's disease exclusion diet in people with Crohn's Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Cded in remission patients with high calprotectin Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Crohn's disease exclusion diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 14 May 2021to 20 Jun 2023
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients under 18 years of age
- With a diagnosis of CD
- Who have completed remission induction with biologic therapy
- Who are on maintenance biologic therapy
- Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).
Who cannot join
- Children who are unable to receive enteral dietary intake
- Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
- Children already on special diets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
Cded in remission patients with high calprotectin
Read the detailed description
Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.
- Conditions
- Crohn's Disease
- Being tested
- Crohn's disease 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.
Crohn's disease exclusion dietDietary supplement
Patients will receive, in addition to their normal treatment, polymeric formula + diet
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | Patients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin. Receives: Dietary Supplement: Crohn's disease exclusion diet |
| Control | No intervention | Patients with normal treatment( biologic treatment indicated for CD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with calprotectin less than 250 at week 12
Number of participants who achieve normal fecal calprotectin after the diet
Measured: week 12
Level of calprotectin
To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.
Measured: week 12
Secondary outcomes (1)
Adherence
Number of patients that were able to continue the diet and not drop out during at least the 12 weeks of the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start14 May 2021
- Primary completion1 Jun 2023
- Study completion20 Jun 2023
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 Crohn's 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA SOLEDAD ARCUCCI, Hospital Italiano de Buenos Aires
- Investigators
- Marina Orsi, M.D., Principal investigator, Hospital Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034458
- Sponsor's protocol ID
- 5992
- Status last verified
- Sep 2023
- First submitted
- 12 Jun 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arcucci MS, Menendez L, Orsi M, Gallo J, Guzman L, Busoni V, Lifschitz C. Role of adjuvant Crohn's disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn's disease having biochemical activity: A randomized, pilot study. Indian J Gastroenterol. 2024 Feb;43(1):199-207. doi: 10.1007/s12664-023-01416-x. Epub 2023 Aug 23.
PubMed 37610564
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
- ClinicalTrials.gov ID
- NCT05034458
- Acronym / sponsor ID
- 5992
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 5 Sep 2021 (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.
Cded in remission patients with high calprotectin
Detailed description
Due to the success of diet in achieving remission in mild-moderate forms of the disease, and an increasing number of patients with loss of response to available drugs despite increasing dose and pathophysiology of the disease, the aim of the present study is to evaluate whether there is response with the addition of diet therapy in patients with moderate/severe forms of CD receiving biologic therapy (infliximab or adalimumab) and presenting active disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Dietary Supplement: Crohn's disease exclusion dietPatients will do biologic treatment according to international guidelines and will do Crohns Disease Exclusion Diet( modulen- phase one ant two CDED) for 12 weeks.They will be monitored periodically by interview and physical examination by physician and nutritionist, laboratory, fecal calprotectin. |
| Control | No intervention | –Patients with normal treatment( biologic treatment indicated for CD) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients under 18 years of age
- With a diagnosis of CD
- Who have completed remission induction with biologic therapy
- Who are on maintenance biologic therapy
- Present calprotectin values higher than the limit values established by the laboratory (higher than 250 ug/g).
Key exclusion criteria (3 listed)
- Children who are unable to receive enteral dietary intake
- Comorbidities affecting nutritional status and/or bone metabolism, growth or pubertal development
- Children already on special diets
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 |
|---|---|---|
| Crohn's disease exclusion dietPatients will receive, in addition to their normal treatment, polymeric formula + diet | Dietary supplement | Diet |
Primary outcome
Number of Participants with calprotectin less than 250 at week 12
Time frame: week 12
Number of participants who achieve normal fecal calprotectin after the diet
Level of calprotectin
Time frame: week 12
To evaluate the change of the calprotectin value at 0 and 12 weeks in patients with or without the addition of dietary therapy.
1 secondary outcome
Adherence
Time frame: 12 weeks
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 25 Sep 2023.
- Derived from this study: PubMed 37610564Arcucci MS, Menendez L, Orsi M, Gallo J, Guzman L, Busoni V, Lifschitz C. Role of adjuvant Crohn's disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn's disease having biochemical activity: A randomized, pilot study. Indian J Gastroenterol. 2024 Feb;43(1):199-207. doi: 10.1007/s12664-023-01416-x. Epub 2023 Aug 23.
- Individual participant dataSharing planned: No
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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.
Marina Orsi, M.D. principal investigator
Hospital Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crohn's disease exclusion diet in people with Crohn's Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 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 25 Sep 2023. 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 Argentina. 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?
Number of Participants with calprotectin less than 250 at week 12 (time frame: week 12). The study lists 2 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 NCT05034458, 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 25 Sep 2023.