Effect of Unripe Banana Flour on Gut-Derived Uremic Toxins in Individuals Undergoing Peritoneal Dialysis: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

Abstract

In chronic kidney disease (CKD), the accumulation of gut-derived metabolites, such as indoxyl sulfate (IS), p-cresyl sulfate (pCS), and indole 3-acetic acid (IAA), has been associated with the burden of the disease. In this context, prebiotics emerge as a strategy to mitigate the accumulation of such compounds, by modulating the gut microbiota and production of their metabolites. The aim of this study was to evaluate the effect of unripe banana flour (UBF—48% resistant starch, a prebiotic) on serum concentrations of IS, pCS, and IAA in individuals undergoing peritoneal dialysis (PD). A randomized, double-blind, placebo-controlled, crossover trial was conducted. Forty-three individuals on PD were randomized to sequential treatment with UBF (21 g/day) and placebo (waxy corn starch—12 g/day) for 4 weeks, or vice versa (4-week washout). The primary outcomes were total and free serum levels of IS, pCS, and IAA. Secondary outcomes were 24 h urine excretion and dialysis removal of IS, pCS, and IAA, serum inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α)], serum lipopolysaccharide LPS, and dietary intake. Of the 43 individuals randomized, 26 completed the follow-up (age = 55 ± 12 years; 53.8% men). UBF did not promote changes in serum levels of IS (p = 0.70), pCS (p = 0.70), and IAA (p = 0.74). Total serum IS reduction was observed in a subgroup of participants (n = 11; placebo: median 79.5 μmol/L (31–142) versus UBF: 62.5 μmol/L (31–133), p = 0.009) who had a daily UBF intake closer to that proposed in the study. No changes were observed in other secondary outcomes. UBF did not promote changes in serum levels of IS or pCS and IAA; a decrease in IS was only found in the subgroup of participants who were able to take 21g/day of the UBF.

Probiotics, Prebiotics, and Synbiotics Improve Uremic, Inflammatory, and Gastrointestinal Symptoms in End-Stage Renal Disease With Dialysis: A Network Meta-Analysis of Randomized Controlled Trials

“…These trials evaluated 4 different treatment agents, including probiotics, prebiotics, synbiotics, and placebo. Out of 25 studies, nine studies ( 22 , 25 , 26 , 30 , 32 , 34 , 36 , 39 , 40 ) compared prebiotics with placebo, nine studies ( 16 , 21 , 24 , 27 – 29 , 37 , 41 , 42 ) compared probiotics with placebo, six studies ( 15 , 20 , 23 , 33 , 35 , 38 ) compared synbiotics with placebo as well as one study ( 31 ) was three-arm RCT that compared probiotics, synbiotics and placebo.…”

“…Among the 25 studies, 15 studies ( 15 , 16 , 22 , 24 , 27 , 29 , 31 , 32 , 36 – 42 ) mentioned the method of random sequence generation and were rated as “low risk,” 11 articles ( 15 , 16 , 24 , 27 , 28 , 31 , 37 , 39 – 42 ) referred to allocation concealment, were rated as “low risk,” 16 articles ( 15 , 16 , 24 , 27 – 32 , 34 , 36 – 41 ) reported how the Blinding of participants and personnel performed, and 14 studies ( 15 , 16 , 23 , 24 , 27 , 28 , 30 – 32 , 36 – 38 , 40 , 41 ) reported the Blinding of outcome assessment. Supplementary Figures 1 , 2 summarized the all risks of bias.…”

Effects of Resistant Starch on Patients with Chronic Kidney Disease: A Systematic Review and Meta-Analysis

“…Table 1 lists the specific characteristics of the 8 studies. Since Marta et al 2020 [ 22 ] and Andrade et al 2021 [ 26 ] adopted the treatment of intervention—washout period—reintervention, it was divided into two research groups according to the treatment before and after the washout period. According to the type of CKD (dialysis or nondialysis), we divided the data into different subgroups for combined analysis.…”

Effectiveness of Microecological Preparations for Improving Renal Function and Metabolic Profiles in Patients With Chronic Kidney Disease

“…The basic characteristics of the 28 RCTs are summarized in Table 1 ( 7 – 9 , 15 , 19 – 42 ). Among them, almost all the studies were double-blinded, except for five (2 were single-blinded, 2 were open-label, and the other was triple-blinded).…”

“…Several studies have reported that probiotics, prebiotics, and/or synbiotics are good for the treatment of CKD by modulating the immune response, improving glomerular function, and lowering serum uremic toxins and inflammatory factors. However, some other articles reached contradictory conclusions (7)(8)(9). Although a small number of studies have systematically evaluated the efficacy of probiotics, prebiotics, and synbiotics in the treatment of CKD, their conclusions are inconsistent and very different (10)(11)(12)(13).…”