Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ljubljana, Słowenia, 1000
- Rekrutacyjny
- University Medical Centre Ljubljana
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Kontakt:
- Darja Urlep, MD, MSc
- Numer telefonu: 0038631646347
- E-mail: darja.urlep@gmail.com
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Kontakt:
- Evgen Benedik, PhD
- Numer telefonu: 0038631745549
- E-mail: evgen.benedik@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: PEN group
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.
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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.
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Aktywny komparator: EEN group
Exclusive enteral nutrition (EEN) group will receive 100 % of their daily caloric requirements from a poymeric formula (Alicalm, Nutricia) for 6 weeks.
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EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Clinical Remission
Ramy czasowe: 6 weeks
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Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy.
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6 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Clinical response
Ramy czasowe: 6 weeks
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- 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
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6 weeks
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Mucosal healing
Ramy czasowe: 6-8 weeks
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Mucosal healing using the Simple Endoscopic Score for CD (SES-CD)
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6-8 weeks
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Change in SES-CD
Ramy czasowe: At week 0 and 6 -8 weeks following enrollment
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Change in SES-CD from baseline to 6 weeks
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At week 0 and 6 -8 weeks following enrollment
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Changes in specific blood tests
Ramy czasowe: At the 1, 3 and 6 weeks visits
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Changes in specific blood tests such as erythrocyte sedimentation rate (ESR), C reactive protein, hemoglobin, albumin, and platelets from baseline to 6 weeks
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At the 1, 3 and 6 weeks visits
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Changes in stool calprotectin concentrations
Ramy czasowe: At the 3 and 6 weeks visits
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Changes in stool calprotectin concentrations (mg/kg) from baseline to 6 weeks
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At the 3 and 6 weeks visits
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Changes in weight-z-scores
Ramy czasowe: At the 0 and 6 weeks visits
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Changes in weight-z-scores
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At the 0 and 6 weeks visits
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Changes in ITM -z-scores
Ramy czasowe: At the 0 and 6 weeks visits
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Changes in ITM -z-scores
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At the 0 and 6 weeks visits
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Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Rok Orel, MD, PhD, University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition
Publikacje i pomocne linki
Publikacje ogólne
- Sigall-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.
- 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.
- Urlep 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20150146
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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