Dynamic Response of the Human Virome to Dietary Intervention

HAT participants underwent weekly self-testing.Self-testing consisted of answering questions regarding disease activity, adherence, side effects, and measurement of weight.An educational curriculum was delivered at the end of each session.Alerts and action plans were generated based on the results.The BAC arm underwent routine follow up, received written action plans and were given educational fact sheets.Seo Index and IBDQ scores were measured every 4 months for 1 year.Intention to treat analyses and analyses of trial completers using all available data were performed.Results: 25 patients were randomized to UC HAT and 22 to BAC.At baseline, 56% of UC HAT participants were on immune suppressants (IS) compared to 27% in BAC (p=0.05).BAC participants had higher QoL scores (191 vs. 172, p=0.02) and lower depression scores (16 vs. 21, p=0.01) than UC HAT at baseline.After 12 months, 11 (44%) participants withdrew in UC HAT compared to 5 (24%) in BAC.Disease activity, QoL, and adherence were not significantly different between groups at any time point post baseline in intention to treat analyses.An analysis of trial completers adjusting for baseline QoL showed that UC HAT participants had a decrease in Seo index scores of 11.9+/-6.6 points from baseline (p=0.08)compared to 1.2+/-6.0 in BAC (p=ns).Analysis of trial completers, adjusting for baseline disease knowledge, demonstrated improved QoL in UC HAT participants compared to BAC at 12 months (+12.5+/-5.9 vs. -3.8+/-5.3).The difference in IBDQ scores at 12 months from baseline between groups was 16.3+/-7.9(p= 0.04).Conclusions: UC HAT did not improve disease activity or QoL compared to BAC after 1 year.However, UC HAT participants demonstrated improvements from baseline in disease activity and QoL in analyses of trial completers.Our results suggest a potential benefit of UC HAT.Further research is indicated to determine if telemedicine improves outcomes in patients with IBD.