Efeitos da suplementação de polidextrose na função intestinal de pacientes em hemodiálise: ensaio clínico randomizado, duplo-cego e controlado

Abstract

Introduction: constipation is a frequent complication in chronic kidney disease (CKD) patients, leading to numerous consequences as abdominal discomfort and changes in the composition of the intestinal microbiota, which contributes to the accumulation of uremic toxins and increased inflammation in these patients. Controlling constipation is a challenge, especially for hemodialysis (HD) patients, who need to restrict water and certain foods, due to the conditions imposed by the disease, resulting in a dietary pattern characterized by low fiber, fluid, and bioactive compound content. Studies have evaluated the effects of polydextrose (PDX) supplementation on intestinal function, with favorable results such as improvement in frequency, bowel movements and improvement in intestinal transit time. However, clinical evidence about PDX effects in CKD patients are scarce. Objectives: to analyze the effects of PDX supplementation on intestinal function in CKD patients on HD. Methods: this is a randomized double-blind, placebo-controlled clinical trial where 28 patients with CKD on HD were selected at DAVITA Serviços de Nefrologia Cabo Frio LTDA- Cabo Frio/ RJ/ Brazil. Patients were allocated into two groups: the intervention group the and control group, to receive 2 sachets/day, totaling 12g of PDX, or 8g of corn starch, respectively, for two months. Blood collections were performed at baseline and after the intervention. To evaluate the serum levels of IL-6 and TNF-alpha, commercial ELISA kits were used. Demographic, clinical and biochemical data were obtained by analyzing the patient's medical record, by interview at the time of consultations/re-consultations or blood collection. To define constipation, the Rome IV criteria were used. Questionnaires were used to assess symptoms of constipation (PAC-SYM - Patient Assessment of Constipation Symptoms) and their impact on patients' quality of life (PAC-QOL - Patient Assessment of Constipation Quality of Life) and to assess stool consistency was Bristol scale was used. Results: 25 patients completed the study: 16 in the PDX group [7 females, 48.5 years (IQR=15.5)] and 9 in the control group [3 females, 44.0 years (IQR=6.0)]. According to ROME IV criteria, 55% of patients were diagnosed with constipation. PAC-SYM-faecal symptoms domain was reduced after two months of PDX supplementation (p=0.004). We also observed a significant reduction in the PAC-QoL-concerns domain (p=0.02). The average values for PAC-SYM and PAC-QoL were reduced significantly after intervention with PDX. There were no significant changes after the intervention period concerning biochemical variables, food intake, and inflammation markers. No adverse effects were observed during the supplementation period. Conclusion: The results of the present study suggest that short-term PDX supplementation may have favourable results on intestinal function and the quality of life of CKD patients in HD.