N/A
N=13
Gut Microbiome and p-Inulin in Hemodialysis
End-Stage Renal Disease · Gut Microbiome Dysbiosis
Bottom Line
View on ClinicalTrials.gov: NCT02572882 ↗Enrolled (actual)
13
Serious AEs
8.6%
Results posted
Oct 2022
Primary outcome: Primary: Within Participant Variability in Microbiome Composition by Treatment Phase — 0.165; 0.175; 0.210 weighted unifrac distrance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- p-inulin (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Within Participant Variability in Microbiome Composition by Treatment Phase |
0.165; 0.175; 0.210 | — |
| PRIMARY Within Participant Variability in Stool Metabolome by Treatment Phase |
14.49; 15.70; 16.77 | — |
| PRIMARY Within Participant Variability in Plasma Metabolome by Treatment Phase |
9.48; 9.47; 9.72 | — |
| SECONDARY Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome) |
5.69; 6.23; 3.68; 4.36; 6.00; 5.27 | — |
| SECONDARY Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome) |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome) |
0; 3; 0 | — |
| SECONDARY Number of Participants With Adverse Events (Safety Outcome) |
1; 2; 0 | — |
| SECONDARY Number of Serious Adverse Events (Safety Outcome) |
3; 0; 1 | — |
| SECONDARY Rate of Enrollment Refusal (Feasibility Outcome) |
— | — |
| SECONDARY Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) |
97; 100; 97 | — |
| SECONDARY Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) |
99; 100; 94 | — |
| SECONDARY Adherence Rate of P-inulin Use (Feasibility Outcome) |
0; 89.5; 0 | — |
| SECONDARY Rate of Study Withdrawal (Feasibility Outcome) |
0; 2; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02572882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.