FindTrial
Sign In

Effect of Unripe Banana Flour on gut and uremic compounds in patients on Peritoneal Dialysis

Effect of Unripe Banana Flour on gut microbiota and uremic toxins in patients on Peritoneal Dialysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4xxwwj
Enrollment
Unknown
Registered
2018-12-20
Start date
2018-07-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Insufficiency

Interventions

The study will involve 50 people with chronic kidney disease on peritoneal dialysis. Experimental group: 25 people will be instructed to use 10 g of unripe banana flour twice daily for four weeks. Con
Dietary supplement
D09.301.416

Sponsors

Universidade Federal de São Paulo - UNIFESP
Lead Sponsor
Universidade Federal de São Paulo - UNIFESP
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 3 months or more in peritoneal dialysis; adherence to dialysis treatment.

Exclusion criteria

Exclusion criteria: Use of prebiotics, probiotics, synbiotics and antibiotics within the previous 30-day period at the beginning of the study; Crohn's disease or ulcerative colitis; severe hepatic disease; cancer; serum positive for the Human Immunodeficiency Virus (HIV); peritonitis or infection at the exit site; stomach or bowel resection; pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Significant reductions (p less than 0.05) in serum concentrations of p-cresyl sulfate and indoxyl sulfate, which will be determined by laboratory dosage, after supplementation with unripe banana flour compared to supplementation with placebo.—

Secondary

MeasureTime frame
Significant reduction (p less than 0.05) in serum endotoxin concentration, which will be determined by laboratory dosage, after supplementation with unripe banana flour compared to supplementation with placebo.;Significant reductions (p less than 0.05) in serum concentrations of inflammatory markers (IL-6, TNF-alpha and CRP), which will be determined by laboratory dosage, after supplementation with unripe banana flour compared to supplementation with placebo.;Significant change in the intestinal microbiota profile, evaluated from fecal samples, by independent technique of cultivation, high yield, in platform Illumina MiSeq, after supplementation with unripe banana flour compared to supplementation with placebo.—

Countries

Brazil

Contacts

Public ContactLilian Cuppari

Universidade Federal de São Paulo - UNIFESP

lcuppari@uol.com.br+55 11 59048499

Outcome results

None listed

Source: REBEC (via WHO ICTRP)