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Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease

6. juni 2017 oppdatert av: Darja Urlep, University Medical Centre Ljubljana

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Rekruttering
        • University Medical Centre Ljubljana
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 30 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Aktiv 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical Remission
Tidsramme: 6 weeks
Clinical Remission (Pediatric Crohn's Disease Activity Index <10) on an intention to treat principle after 6 weeks of therapy.
6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinical response
Tidsramme: 6 weeks
- 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
6 weeks
Mucosal healing
Tidsramme: 6-8 weeks
Mucosal healing using the Simple Endoscopic Score for CD (SES-CD)
6-8 weeks
Change in SES-CD
Tidsramme: At week 0 and 6 -8 weeks following enrollment
Change in SES-CD from baseline to 6 weeks
At week 0 and 6 -8 weeks following enrollment
Changes in specific blood tests
Tidsramme: At the 1, 3 and 6 weeks visits
Changes in specific blood tests such as erythrocyte sedimentation rate (ESR), C reactive protein, hemoglobin, albumin, and platelets from baseline to 6 weeks
At the 1, 3 and 6 weeks visits
Changes in stool calprotectin concentrations
Tidsramme: At the 3 and 6 weeks visits
Changes in stool calprotectin concentrations (mg/kg) from baseline to 6 weeks
At the 3 and 6 weeks visits
Changes in weight-z-scores
Tidsramme: At the 0 and 6 weeks visits
Changes in weight-z-scores
At the 0 and 6 weeks visits
Changes in ITM -z-scores
Tidsramme: At the 0 and 6 weeks visits
Changes in ITM -z-scores
At the 0 and 6 weeks visits

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Medical Centre Ljubljana

Etterforskere

  • Studiestol: Rok Orel, MD, PhD, University Medical Centre Ljubljana, University Children's Hospital Ljubljana, Department of gastroenterology, hepatology and nutrition

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. mai 2017

Primær fullføring (Forventet)

31. juli 2018

Studiet fullført (Forventet)

31. desember 2018

Datoer for studieregistrering

Først innsendt

25. mai 2017

Først innsendt som oppfylte QC-kriteriene

5. juni 2017

Først lagt ut (Faktiske)

6. juni 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20150146

Plan for individuelle deltakerdata (IPD)

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