Daniela Viramontes-Hörner1, Fabiola Márquez-Sandoval2, Fabiola Martín-del-Campo3, Barbara Vizmanos-Lamotte2, Ana Sandoval-Rodríguez4, Juan Armendáriz-Borunda4, Héctor García-Bejarano5, Karina Renoirte-López6, Guillermo García-García6. 1. Departamento de Disciplinas Filosófico Metodológico e Instrumentales, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, México. 2. CA-UDG-454 "Alimentación y nutrición en el proceso salud-enfermedad", Departamento de Reproducción Humana, Crecimiento y Desarrollo Infantil, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, México. 3. Departamento de Disciplinas Filosófico Metodológico e Instrumentales, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, México. Electronic address: fabi_mc@hotmail.com. 4. Departamento de Biología Molecular y Genómica, Instituto de Biología Molecular y Terapia Génica, Universidad de Guadalajara, Guadalajara, México. 5. Departamento de Nefrología, Hospital General de Occidente, Zapopan, México. 6. División de Nefrología, O.P.D. Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, México.
Abstract
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.
RCT Entities:
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 tumornecrosis 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.
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