Ornella Guardamagna1, Alberto Amaretti2, Paolo Emilio Puddu3, Stefano Raimondi2, Francesca Abello4, Paola Cagliero4, Maddalena Rossi2. 1. Dipartimento di Scienze della Sanità pubblica e Pediatriche, Università di Torino, Torino, Italy. Electronic address: ornella.guardamagna@unito.it. 2. Dipartimento di Scienze della Vita, Università di Modena e Reggio Emilia, Modena, Italy. 3. Dipartimento di Scienze Cardiovascolari, Università la Sapienza di Roma, Roma, Italy. 4. Dipartimento di Scienze della Sanità pubblica e Pediatriche, Università di Torino, Torino, Italy.
Abstract
OBJECTIVE: Preclinical investigations support the use of probiotics in the treatment of hypercholesterolemia, but clinical evidence is often contrasting. The aim of this study was to evaluate the effects of a probiotic formulation containing three Bifidobacterium strains on lipid profiles in children affected by primary dyslipidemia. METHODS:Thirty-eight children with dyslipidemia, ages 10.8 ± 2.1 y, were enrolled in a randomized, double-blind, placebo-controlled cross-over study. After a 4-wk diet run-in period, the children received probiotics (B. animalis subspecies lactis MB 2409, B. bifidum MB 109B, and B. longum subspecies longum BL04) or placebo for 3 mo. After 1 mo, wash-out treatments were switched. A strict dietary evaluation concerning satured fatty acids and cholesterol content, STEP I diet accordingly, was performed by a dietitian who examined the weekly dietary diary at each visit. RESULTS:Baseline lipid profile was (mean ± SD): total cholesterol (TC) 222.8 ± 23.2 mg/dL, high-density lipoprotein cholesterol (HDL-C) 55.8 ± 12.2 mg/dL, triglycerides (TG) 99.0 ± 61.7 mg/dL, and low-density lipoprotein cholesterol (LDL-C) 147.2 ± 21.9 mg/dL. After 3 mo of probiotic treatment, the lipid profile was: TC 211.9 ± 27.3 mg/dL, HDL-C 60.7 ± 14.2 mg/dL, TG 79.5 ± 34.5 mg/dL, and LDL-C 135.3 ± 24.2 mg/dL. Compared with placebo, probiotics reduced TC by 3.4% (P = 0.02) and LDL-C by 3.8% (P = 0.001). No significant dietary change occurred through the study and no relevant adverse effects were observed. CONCLUSIONS: Treatment with a Bifidobacterium probiotic formulation was well tolerated and useful in combination with to diet therapy. Children with dyslipidemia benefited from this approach, although the results need to be confirmed by larger controlled studies.
RCT Entities:
OBJECTIVE: Preclinical investigations support the use of probiotics in the treatment of hypercholesterolemia, but clinical evidence is often contrasting. The aim of this study was to evaluate the effects of a probiotic formulation containing three Bifidobacterium strains on lipid profiles in children affected by primary dyslipidemia. METHODS: Thirty-eight children with dyslipidemia, ages 10.8 ± 2.1 y, were enrolled in a randomized, double-blind, placebo-controlled cross-over study. After a 4-wk diet run-in period, the children received probiotics (B. animalis subspecies lactis MB 2409, B. bifidum MB 109B, and B. longum subspecies longum BL04) or placebo for 3 mo. After 1 mo, wash-out treatments were switched. A strict dietary evaluation concerning satured fatty acids and cholesterol content, STEP I diet accordingly, was performed by a dietitian who examined the weekly dietary diary at each visit. RESULTS: Baseline lipid profile was (mean ± SD): total cholesterol (TC) 222.8 ± 23.2 mg/dL, high-density lipoprotein cholesterol (HDL-C) 55.8 ± 12.2 mg/dL, triglycerides (TG) 99.0 ± 61.7 mg/dL, and low-density lipoprotein cholesterol (LDL-C) 147.2 ± 21.9 mg/dL. After 3 mo of probiotic treatment, the lipid profile was: TC 211.9 ± 27.3 mg/dL, HDL-C 60.7 ± 14.2 mg/dL, TG 79.5 ± 34.5 mg/dL, and LDL-C 135.3 ± 24.2 mg/dL. Compared with placebo, probiotics reduced TC by 3.4% (P = 0.02) and LDL-C by 3.8% (P = 0.001). No significant dietary change occurred through the study and no relevant adverse effects were observed. CONCLUSIONS: Treatment with a Bifidobacterium probiotic formulation was well tolerated and useful in combination with to diet therapy. Children with dyslipidemia benefited from this approach, although the results need to be confirmed by larger controlled studies.
Authors: Eleonora Scorletti; Paul R Afolabi; Elizabeth A Miles; Debbie E Smith; Amal Almehmadi; Albandri Alshathry; Caroline E Childs; Stefania Del Fabbro; Josh Bilson; Helen E Moyses; Geraldine F Clough; Jaswinder K Sethi; Janisha Patel; Mark Wright; David J Breen; Charles Peebles; Angela Darekar; Richard Aspinall; Andrew J Fowell; Joanna K Dowman; Valerio Nobili; Giovanni Targher; Nathalie M Delzenne; Laure B Bindels; Philip C Calder; Christopher D Byrne Journal: Gastroenterology Date: 2020-01-25 Impact factor: 33.883