AdolescentNCT03176875
Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
A study testing ALICALM (75% of daily caloric requirements) and ALICALM (100% of daily caloric requirements) in people with Adolescent and Child, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral… Read more about this study
- Who is it for?
- Ages 4 to 30 years
- Conditions the study is for
- Adolescent, Child, Diet
- What is being tested?
- ALICALM (75% of daily caloric requirements) and ALICALM (100% of daily caloric requirements)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 25 May 2017to 31 Dec 2018
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (4 - 18 years of age)
- Young adults (>18 and ≤ 30 years of age) with childhood-onset CD (the diagnosis of CD before 18 years of age)
- Assured diagnosis of Crohn's disease according to the Porto criteria
- Patients with Active CD (Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 in children or Harvey-Bradshaw Index (HBI) >3 in young adults )
- Patients with new-onset CD and patients with active disease despite stable doses of concomitant therapy with immunomodulators (thiopurines, methotrexate, tacrolimus) for ≥ 3 months, on stable doses of biologic therapy (anti-TNF-a agents) for ≥ 2 months
- Patients will not be excluded if they start therapy with thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks
- Written consent of the patient and/or the legal guardian
Who cannot join
- Patients with no disease activity ( PCDAI <10)
- Patients who have received corticosteroids of any kind in the previous 4 weeks.
- Patients with penetrating disease (abscess or fistula)
- Active Perianal disease
- Active Extraintestinal disease
- Sclerosing Cholangitis
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- Patients with fixed stricture or small bowel obstruction
- If the patients had received any other medication for inducing remission such as steroids and/or antibiotics
- No consent of the patient and/or the legal guardian
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Darja Urlep, MD, MSc, 0038631646347, darja.urlep@gmail.com
Evgen Benedik, PhD, 0038631745549, evgen.benedik@gmail.com
About this study
The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).
The hypothesis is that no significant difference in the remission rate between the novel EN protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be observed.
Read the detailed description
Background: Exclusive enteral nutrition (EEN) is a well established method of treatment for inducing remission in childhood-onset Crohn's disease. It involves placing children on a strict diet composed only of a single polymeric formula, as the sole source of nutrition over 6 to 8 weeks. Use of this treatment method results in clinical remission in 50% to 80% of children by week 6-8.
Partial enteral nutrition (PEN) would be more acceptable to patients than EEN, and might be an effective treatment for active Crohn's disease. Moreover, there are studies suggesting that PEN may be effective for the induction of remission in pediatric patients with Crohn's disease; however, the level of evidence is still low.
Methods: This is a prospective randomized controlled trial, in patients with active childhood-onset Crohn's disease comparing two arms over 6 weeks of therapy.
Group 1 (PEN group): will receive 75% of their dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) whole food AID-CD for 6 weeks.
Group 2 (EEN group): will receive EEN with Alicalm (Nutricia) for 6 weeks.
Patients will be seen at onset and week 1, 3, and 6.
This study will evaluate clinical response (a decrease in PCDAI score of ≥12.5 points), clinical remission (PCDAI <10) and mucosal healing using SES-CD in both groups, as well as the effects of the two nutritional approaches on the patients' nutritional status.
Antiinflammatory diet for Crohn's disease (AID-CD) is based on reducing exposure to animal fat, simple carbohydrates and processed food. We removed foods that previous research has shown to induce inflammation and added foods that have been shown to be beneficial in reducing inflammation. Our AID-CD is based on Central European and thus Slovenian local and traditional cuisine.
- Conditions
- Adolescent, Child, Diet, Crohn Disease, Enteral Nutrition, Remission
- Being tested
- ALICALM (75% of daily caloric requirements), ALICALM (100% of daily caloric requirements)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALICALM (75% of daily caloric requirements)Other
PEN group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and 25% of daily dietary needs (1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks.
ALICALM (100% of daily caloric requirements)Other
EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PEN group | Experimental | Partial enteral nutrition (PEN) group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks. Receives: Other: ALICALM (75% of daily caloric requirements) |
| EEN group | Active comparator | Exclusive enteral nutrition (EEN) group will receive 100 % of their daily caloric requirements from a poymeric formula (Alicalm, Nutricia) for 6 weeks. Receives: Other: ALICALM (100% of daily caloric requirements) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy.
Measured: 6 weeks
Secondary outcomes (7)
Clinical response
- Clinical response defined as a decrease in Pediatric Crohn's Disease Activity Index score of ≥12.5 points) for children or a drop in HBI of at least 2 points in young adults
Measured: 6 weeks
Mucosal healing
Mucosal healing using the Simple Endoscopic Score for CD (SES-CD)
Measured: 6-8 weeks
Change in SES-CD
Change in SES-CD from baseline to 6 weeks
Measured: At week 0 and 6 -8 weeks following enrollment
Changes in specific blood tests
Changes in specific blood tests such as erythrocyte sedimentation rate (ESR), C reactive protein, hemoglobin, albumin, and platelets from baseline to 6 weeks
Measured: At the 1, 3 and 6 weeks visits
Changes in stool calprotectin concentrations
Changes in stool calprotectin concentrations (mg/kg) from baseline to 6 weeks
Measured: At the 3 and 6 weeks visits
Changes in weight-z-scores
Changes in weight-z-scores
Measured: At the 0 and 6 weeks visits
Changes in ITM -z-scores
Changes in ITM -z-scores
Measured: At the 0 and 6 weeks visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start25 May 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darja Urlep, University Medical Centre Ljubljana
- Investigators
- Rok Orel, MD, PhD, Study chair, University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176875
- Sponsor's protocol ID
- 20150146
- Status last verified
- Jun 2017
- First submitted
- 25 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta K, Noble A, Kachelries KE, Albenberg L, Kelsen JR, Grossman AB, Baldassano RN. A novel enteral nutrition protocol for the treatment of pediatric Crohn's disease. Inflamm Bowel Dis. 2013 Jun;19(7):1374-8. doi: 10.1097/MIB.0b013e318281321b.
PubMed 23567777Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.
PubMed 24983973Urlep D, Benedik E, Brecelj J, Orel R. Partial enteral nutrition induces clinical and endoscopic remission in active pediatric Crohn's disease: results of a prospective cohort study. Eur J Pediatr. 2020 Mar;179(3):431-438. doi: 10.1007/s00431-019-03520-7. Epub 2019 Nov 28.
PubMed 31781933
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
- ClinicalTrials.gov ID
- NCT03176875
- Acronym / sponsor ID
- 20150146
- Conditions
- Adolescent, Child, Diet, Crohn Disease, Enteral Nutrition, Remission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 Jun 2017 (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.
The primary objective of this study is to determine the efficacy of a novel enteral nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).
The hypothesis is that no significant difference in the remission rate between the novel EN protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be observed.
Detailed description
Background: Exclusive enteral nutrition (EEN) is a well established method of treatment for inducing remission in childhood-onset Crohn's disease. It involves placing children on a strict diet composed only of a single polymeric formula, as the sole source of nutrition over 6 to 8 weeks. Use of this treatment method results in clinical remission in 50% to 80% of children by week 6-8.
Partial enteral nutrition (PEN) would be more acceptable to patients than EEN, and might be an effective treatment for active Crohn's disease. Moreover, there are studies suggesting that PEN may be effective for the induction of remission in pediatric patients with Crohn's disease; however, the level of evidence is still low.
Methods: This is a prospective randomized controlled trial, in patients with active childhood-onset Crohn's disease comparing two arms over 6 weeks of therapy.
Group 1 (PEN group): will receive 75% of their dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) whole food AID-CD for 6 weeks.
Group 2 (EEN group): will receive EEN with Alicalm (Nutricia) for 6 weeks.
Patients will be seen at onset and week 1, 3, and 6.
This study will evaluate clinical response (a decrease in PCDAI score of ≥12.5 points), clinical remission (PCDAI <10) and mucosal healing using SES-CD in both groups, as well as the effects of the two nutritional approaches on the patients' nutritional status.
Antiinflammatory diet for Crohn's disease (AID-CD) is based on reducing exposure to animal fat, simple carbohydrates and processed food. We removed foods that previous research has shown to induce inflammation and added foods that have been shown to be beneficial in reducing inflammation. Our AID-CD is based on Central European and thus Slovenian local and traditional cuisine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEN group | Experimental | Other: ALICALM (75% of daily caloric requirements)Partial enteral nutrition (PEN) group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks. |
| EEN group | Active comparator | Other: ALICALM (100% of daily caloric requirements)Exclusive enteral nutrition (EEN) group will receive 100 % of their daily caloric requirements from a poymeric formula (Alicalm, Nutricia) for 6 weeks. |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children (4 - 18 years of age)
- Young adults (>18 and ≤ 30 years of age) with childhood-onset CD (the diagnosis of CD before 18 years of age)
- Assured diagnosis of Crohn's disease according to the Porto criteria
- Patients with Active CD (Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 in children or Harvey-Bradshaw Index (HBI) >3 in young adults )
- Patients with new-onset CD and patients with active disease despite stable doses of concomitant therapy with immunomodulators (thiopurines, methotrexate, tacrolimus) for ≥ 3 months, on stable doses of biologic therapy (anti-TNF-a agents) for ≥ 2 months
Key exclusion criteria (9 listed)
- Patients with no disease activity ( PCDAI <10)
- Patients who have received corticosteroids of any kind in the previous 4 weeks.
- Patients with penetrating disease (abscess or fistula)
- Active Perianal disease
- Active Extraintestinal disease
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 |
|---|---|---|
| ALICALM (75% of daily caloric requirements)PEN group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and 25% of daily dietary needs (1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks. | Other | PEN group |
| ALICALM (100% of daily caloric requirements)EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks. | Other | EEN group |
Primary outcome
Clinical Remission
Time frame: 6 weeks
Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy.
7 secondary outcomes
Clinical response
Time frame: 6 weeks
Mucosal healing
Time frame: 6-8 weeks
Change in SES-CD
Time frame: At week 0 and 6 -8 weeks following enrollment
Changes in specific blood tests
Time frame: At the 1, 3 and 6 weeks visits
Changes in stool calprotectin concentrations
Time frame: At the 3 and 6 weeks visits
Changes in weight-z-scores
Time frame: At the 0 and 6 weeks visits
Changes in ITM -z-scores
Time frame: At the 0 and 6 weeks visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Background: PubMed 23567777Gupta K, Noble A, Kachelries KE, Albenberg L, Kelsen JR, Grossman AB, Baldassano RN. A novel enteral nutrition protocol for the treatment of pediatric Crohn's disease. Inflamm Bowel Dis. 2013 Jun;19(7):1374-8. doi: 10.1097/MIB.0b013e318281321b.
- Background: PubMed 24983973Sigall-Boneh R, Pfeffer-Gik T, Segal I, Zangen T, Boaz M, Levine A. Partial enteral nutrition with a Crohn's disease exclusion diet is effective for induction of remission in children and young adults with Crohn's disease. Inflamm Bowel Dis. 2014 Aug;20(8):1353-60. doi: 10.1097/MIB.0000000000000110.
- Derived from this study: PubMed 31781933Urlep D, Benedik E, Brecelj J, Orel R. Partial enteral nutrition induces clinical and endoscopic remission in active pediatric Crohn's disease: results of a prospective cohort study. Eur J Pediatr. 2020 Mar;179(3):431-438. doi: 10.1007/s00431-019-03520-7. Epub 2019 Nov 28.
- 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.
Rok Orel, MD, PhD study chair
University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALICALM (75% of daily caloric requirements) and ALICALM (100% of daily caloric requirements) in people with Adolescent and Child, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 7 inclusion and 9 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 8 Jun 2017. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darja Urlep, MD, MSc (0038631646347, darja.urlep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission (time frame: 6 weeks). 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 NCT03176875, which also lists 3 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 8 Jun 2017.