Objective: The study aimed to assess the effect of a symbiotic gel on presence and severity of gastrointestinal symptoms (GIS) in hemodialysis patients.
Design: A double-blinded, placebo-controlled, randomized, clinical trial was designed. The study was conducted at 2 public hospitals in Guadalajara, Mexico.
Subjects and intervention: Twenty-two patients were randomized to the intervention group (nutritional counseling + symbiotic gel) and 20 patients were randomized to the control group (nutritional counseling + placebo), during 2 months of follow-up.
Main outcome measure: Presence and monthly episodes of GIS were assessed by direct interview and severity by using the self-administered GIS questionnaire. Additionally, biochemical parameters, inflammatory markers, and nutritional status (dietary intake, subjective global assessment, anthropometry, and body composition) were evaluated.
Results: After a 2-month treatment, intervention group had a significant reduction in prevalence and monthly episodes of vomit, heartburn, and stomachache, as well as a significant decrease in GIS severity compared with control group. Moreover, intervention group had a greater yet not significant decrease in the prevalence of malnutrition and a trend to reduce their C-reactive protein and tumor necrosis factor α levels compared with control group. No symbiotic-related adverse side effects were shown in these patients. Clinical studies with longer follow-up and sample size are needed to confirm these results.
Conclusions: We concluded that administration of a symbiotic gel is a safe and simple way to improve common GIS in dialysis patients.
Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.