Abstract
Pain is known to reduce hemodialysis treatment adherence, reduce quality of life, and increase mortality. The absence of effective strategies to treat pain without medications has contributed to poor health outcomes for people with end-stage kidney disease (ESKD) on hemodialysis. It is now recognized that symbiotic microbiota in the gut play a critical role in health and disease, and new evidence sheds light on the role of the microbiome in chronic pain. The pilot study protocol presented here (BIOME-HDp) employs a longitudinal repeated measures design to interrogate the effects of a nonpharmacological pain intervention on the composition and function of the gut microbiome and circulating metabolites. This pilot study is an ancillary study of the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis, which is part of the NIH's Helping to End Addiction Long-term (HEAL) initiative. The BIOME-HDp pilot study will establish clinical microbiome research methods and determine the acceptability and feasibility of fecal microbiome and serum metabolite sample collection.