Gut Microbiome and p-Inulin in Hemodialysis

This primary objective of this exploratory study is to characterize the safety and
tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition
and function of the human gut microbiome, thereby reducing the generation of gut-derived
uremic toxins, improving gut barrier function and attenuating systemic inflammation in
patients treated with maintenance hemodialysis. The study also aims to assess the feasibility
of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial
will be intra- and inter-participant variability in gut metabolites and bacterial
composition. Secondary parameters of interest include tolerability and safety of p-inulin,
willingness of hemodialysis patients to enroll in a study requiring repeated collection of
stool samples, and participant adherence to agent treatment and specimen collection
schedules.

Inclusion Criteria:

- Maintenance hemodialysis therapy for end-stage renal disease

- At least 18 years of age

- At least 90 days since hemodialysis initiation

- Self-reported average stool frequency of at least 1 every other day

- For women of childbearing potential, willingness to use a highly effective method of
birth control for up to 4 weeks after the last dose of p-inulin.

- Ability to provide consent

Exclusion Criteria:

- Use of prebiotics or probiotics during the past 8 weeks

- Consumption of probiotic yogurt during the past 2 weeks

- Use of antibiotics within the past 8 weeks

- Presence of HIV infection, chronic wound infection, osteomyelitis, or current
hemodialysis

- Inflammatory bowel disease, chronic diarrhea, current C. difficile infection

- Cirrhosis or chronic active hepatitis

- Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to
another dialysis unit within 9 months

- Expected survival less than 9 months

- Pregnancy, anticipated pregnancy, or breastfeeding

- Incarceration

- Participation in another intervention study

- Severe anemia defined as hemoglobin <9.0 g/dl within the past 4 weeks as documented in
the dialysis unit patient record