title: Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial.
abstract: OBJECTIVE
  To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer.
  
  
  METHODS
  Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10(8) colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items) questionnaire were the main endpoints.
  
  
  RESULTS
  This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance).
  
  
  CONCLUSIONS
  Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.
authors.affiliation: Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso, Brazil. Electronic address: mari1980hemato@yahoo.com.br.
authors.forename: Mariana
authors.initials: M
authors.lastname: Nascimento
authors.affiliation: Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso, Brazil.
authors.forename: José Eduardo
authors.initials: JE
authors.lastname: Aguilar-Nascimento
authors.affiliation: Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso, Brazil.
authors.forename: Cervantes
authors.initials: C
authors.lastname: Caporossi
authors.affiliation: Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso, Brazil.
authors.forename: Heloisa Michelon
authors.initials: HM
authors.lastname: Castro-Barcellos
authors.affiliation: Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso, Brazil.
authors.forename: Rodrigo Teixeira
authors.initials: RT
authors.lastname: Motta
mesh_terms: D000208:Acute Disease; D000368:Aged; D000704:Analysis of Variance; D004043:Dietary Fiber / Q000008:administration & dosage; D004311:Double-Blind Method; D006801:Humans; D052200:Limosilactobacillus reuteri; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011349:Proctitis / Q000209:etiology / Q000628:therapy*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000628:therapy*; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D011795:Surveys and Questionnaires; D058616:Synbiotics; D013997:Time Factors