| Summary: | 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.
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