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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Aliment+Pharmacol+Ther
2014 ; 39
(11
): 1276-85
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gab.com Text
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Randomised clinical trial: The beneficial effects of VSL#3 in obese children with
non-alcoholic steatohepatitis
#MMPMID24738701
Alisi A
; Bedogni G
; Baviera G
; Giorgio V
; Porro E
; Paris C
; Giammaria P
; Reali L
; Anania F
; Nobili V
Aliment Pharmacol Ther
2014[Jun]; 39
(11
): 1276-85
PMID24738701
show ga
BACKGROUND: Gut microbiota modifiers may have beneficial effects of non-alcoholic
fatty liver disease (NAFLD) but randomised controlled trials (RCT) are lacking in
children. AIM: To perform a double-blind RCT of VSL#3 vs. placebo in obese
children with biopsy-proven NAFLD. METHODS: Of 48 randomised children, 44 (22
VSL#3 and 22 placebo) completed the study. The main outcome was the change in
fatty liver severity at 4 months as detected by ultrasonography. Secondary
outcomes were the changes in triglycerides, insulin resistance as detected by the
homoeostasis model assessment (HOMA), alanine transaminase (ALT), body mass index
(BMI), glucagon-like peptide 1 (GLP-1) and activated GLP-1 (aGLP-1). Ordinal and
linear models with cluster confidence intervals were used to evaluate the
efficacy of VSL#3 vs. placebo at 4 months. RESULTS: At baseline, moderate and
severe NAFLD were present in 64% and 36% of PLA children and in 55% and 45% of
VSL#3 children. The probability that children supplemented with VSL#3 had none,
light, moderate or severe FL at the end of the study was 21%, 70%, 9% and 0%
respectively with corresponding values of 0%, 7%, 76% and 17% for the placebo
group (P < 0.001). No between-group differences were detected in triglycerides,
HOMA and ALT while BMI decreased and GLP-1 and aGLP1 increased in the VSL#3 group
(P < 0.001 for all comparisons). CONCLUSIONS: A 4-month supplement of VSL#3
significantly improves NAFLD in children. The VSL#3-dependent GLP-1 increase
could be responsible for these beneficial effects. Trial identifier: NCT01650025
(www.clinicaltrial.gov).