A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.
Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219.
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Valerio
0000-0001-7651-4567
V
Mezzasalma
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Enrico
E
Manfrini
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Emanuele
E
Ferri
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Anna
0000-0002-5257-0027
A
Sandionigi
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Barbara
B
La Ferla
Farcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Irene
I
Schiano
Farcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Angela
A
Michelotti
Farcoderm Srl., Via Angelini 21, San Martino Siccomario, 27028 Pavia, Italy.
Vincenzo
V
Nobile
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Massimo
0000-0003-1065-5804
M
Labra
Department of Biotechnology and Biosciences, University of Milano-Bicocca, Piazza della Scienza 2, 20126 Milan, Italy.
Patrizia
0000-0002-0865-7627
P
Di Gennaro
D000293:Adolescent; D000328:Adult; D000368:Aged; D003248:Constipation / Q000150:complications / Q000382:microbiology / Q000628:therapy*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000382:microbiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage*