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BACKGROUND: Modulating the large intestinal microbiome of kidney transplant recipients (KTR) may reduce infectious complications. The aim of this study was to assess the feasibility of a randomized controlled trial of prebiotics in reducing infections and gastrointestinal symptoms in KTR.
METHODS: Acute KTR were recruited to a double-blind, placebo-controlled, randomized trial at a single kidney transplant center. Patients were provided with prebiotics or placebo for 7 weeks. The primary outcome was feasibility, defined as recruitment of ≥80% of eligible people within 6 months. Secondary outcomes included adherence and tolerability, participant retention in trial, proportions of participants providing serum and stool specimens, self-reported quality of life (QOL), gastrointestinal symptoms and infection events.
RESULTS: During the 7-week period, 72 patients met eligibility criteria, of whom 60 (83%) consented to participate (mean±SD age 53±12 years; 62% males). Fifty six (78%) participants were randomized (27 intervention and 29 control). While participants receiving intervention experienced reduced gastrointestinal symptoms (-0.28 [IQR -0.67 to 0.08] vs -0.07 [IQR -0.27 to 0], p=0.03), both control and intervention groups were similar in adherence (67% vs. 72%, p=0.36), tolerability (56% vs. 62%, p=0.64), QOL (-0.2 [IQR -0.6 to 0] vs. -0.2 [IQR -0.8 to 0], p=0.82) and infection events (33% vs. 34%, p=0.83). Blood and stool samples were collected from ≥90% of participants in both groups.
CONCLUSIONS: It is feasible to recruit and retain acute KTR in a randomized placebo-controlled trial examining the effect of prebiotics on infections and gastrointestinal symptoms. This study also showed that prebiotics significantly reduced gastrointestinal symptoms.
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Nutrition for Chronic Disease and Disability: Research to improve health related quality of life and bring forward the under-represented voice
1/01/14 → 31/08/30