Abstract
UNLABELLED A quasi-experimental clinical assay was carried out to assess the tolerance, safety and usefulness of a 4 lactobacili + 1 bifidobacterium combination as adjuvant to the pharmacological treatment of UC Ulcerative colitis patients differing in mucosal change. The effectiveness of the probiotic treatment was assessed from changes in patient's stool pattern, body composition, and selected biochemical indicators of disease activity and nutritional status. Fifty patients entered consecutively in the trial between December 2005-June 2009 (CONTROL GROUP 29; Treatment Group: 21). Twenty of them completed treatment with probiotics. Effectiveness of regular pharmacological treatment was recorded with 24 control patients. Thirty-six days of probiotic treatment per patient were accumulated. Probiotic treatment obedience rate was 99.3%. Five days of treatment were lost due to non-availability of the product. No adverse reactions were reported after probiotic treatment. Two deaths were recorded after completion of the study, one on each group. Improvement in the quality of the stools [RR Relative risk: 1.69; 95% IC: 0.87-3.27]; frequency [RR: 1.35; 95% IC: 0.15-11.90]; and volume [RR: 1.11; 95% IC: 0.16-7.63] was observed in treated patients, although biological variability prevented these trends to become statistically significant. Probiotic treatment also resulted in reduction of occurrence of nocturnal depositions [RR: 1.75; 95% IC: 0.53-5.73]. Probiotic treatment prevented the onset of undesirable changes in stool pattern of treated patients who presented free of symptoms, but observed effect was no superior to that of medication administered. Probiotic treatment did not influence upon presence of blood in stools. Probiotic treatment also resulted in reduction of disease activity and ESR Erythro-sedimentation rate, respectively [Change in the Clinical Activity Index: CONTROL GROUP -1.1 ± 3.2 vs. Treatment Group: -4.1 ± 3.3; p < 0.05; Change in ESR: CONTROL GROUP 3.6 ± 16.4 vs. Treatment Group: -6.7 ± 15.6; p < 0.05]. Adjuvant probiotic treatment resulted in increase of body weight, at the expenses of increase of MAMC Mid-arm Muscle Circumference and sum of skinfolds. Probiotic effect upon body weight was not attributed to increased food intakes in treated patients. In spite of clinical heterogeneity associated to mucosal damage in UC, probiotic treatment might result in beneficial effects upon patient's stool pattern, body composition, and selected biochemical indicators of disease activity. Invariance of food intakes could imply that observed changes in response variables were not the result of a placebo effect of used probiotic combination.
