Gut Microbiome and p-Inulin in Hemodialysis

University of Pennsylvania

Status: Completed

Conditions: Gut Microbiome Dysbiosis; End-Stage Renal Disease

Treatments: Dietary Supplement: p-inulin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02572882

U01DK099919 (U.S. NIH Grant/Contract)

823162

Details and patient eligibility

About

The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Single arm

Other group

Description:

This is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment).

Treatment:

Dietary Supplement: p-inulin