Enteral nutrition feeding strategies and their impact on relapse rate and quality of life in paediatric Crohn’s disease
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Aims:
To study induction of remission and reduction in relapse rate of
childhood Crohn’s disease with quality of life (QOL) assessment in
subjects on long term continuous oral supplementation with
ACD004.
Methods:
This study was performed in two phases. In Phase A, ACD004 was
used to assess effectiveness based on proportion of full remission at
8 weeks. Children then reintroduced food over a 4 week phase
reducing their ACD004 intake to 30% RDA, subsequently enrolling
into randomised controlled part of the trial (Phase B), to assess
reduction in relapse rate whilst receiving continuous oral ACD004
supplementation compared to no supplementation. Secondary
objectives of this study were to examine QOL, safety, tolerance and
growth.
Results:
42 children were enrolled in Phase A with 78.6% (n=33) achieving
remission with a significant improvement in endoscopic, histologic
and QOL scores. One child developed refeeding syndrome. A
further 8 children relapsed during the food reintroduction phase and
25 children were enrolled in the Phase B RCT. 12 were randomised to
remain supplemented and 13 had no supplementation. Only 1/3rd of
the calculated study power (n=72) was met due to collapse of trial
following withdrawal of funding. 8/12 in the supplemented and
10/13 in the non-supplemented group relapsed by first year. At 2
years, 4/12 in the supplemented and 2/13 in the non-supplemented
group were in remission. Deterioration in IBD and systemic QOL
7
symptoms related to disease were seen; however there was no
change in emotional and social functioning.
Conculsions:
ACD004 is an effective remission inducing agent, which also
improves QOL despite significantly limiting children’s diet. Due to
early collapse of trial, its role as a supplement remains uncertain; no
benefit seen with limited trial recruitment. In the long-term,
emotional and social domains in QOL remain unaltered, despite
relapse which may be due to disease acceptance.
Authors
Afzal, Nadeem AhmadCollections
- Theses [3831]