A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation

Valerio Mezzasalma, Enrico Manfrini, Emanuele Ferri, Anna Sandionigi, Barbara La Ferla, Irene Schiano, Angela Michelotti, Vincenzo Nobile, Massimo Labra, Patrizia Di Gennaro, Valerio Mezzasalma, Enrico Manfrini, Emanuele Ferri, Anna Sandionigi, Barbara La Ferla, Irene Schiano, Angela Michelotti, Vincenzo Nobile, Massimo Labra, Patrizia Di Gennaro

Abstract

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.

Figures

Figure 1
Figure 1
Study flow and schedule of assessment chart.
Figure 2
Figure 2
Disposition of the subjects of the study.
Figure 3
Figure 3
Percentage of responders to IBS-C related symptom during the treatment period (t60, days) with probiotic formulations F_1 and F_2. The Responders was defined as the subject reporting a decrease of symptoms of at least 30% compared to the basal condition for at least 50% of the intervention time. Bloating, abdominal pain, constipation, abdominal cramps, and flatulence symptoms were assessed on a numbering scale from 0 to 10 for each item subjects scored. Data are mean ± SE. Upon the square brackets are reported the intergroups F_1 and F_2 (versus placebo F_3) statistical analysis (∗∗∗P < 0.001). The intergroups F_1 versus F_2 statistical analysis (∗∗P < 0.01) is also reported.
Figure 4
Figure 4
Percentage of responders to IBS-C related symptom at the follow-up period, that is, 30 days after the last product intake (t90, days) of probiotic formulations F_1 and F_2. The Responders was defined as the subject reporting a decrease of symptoms of at least 30% compared to the basal condition for at least 50% of the intervention time. Bloating, abdominal pain, constipation, abdominal cramps, and flatulence symptoms were assessed on a numbering scale from 0 to 10 for each item subjects scored. Data are mean ± SE. Upon the square brackets are reported the intergroups F_1 and F_2 (versus placebo F_3) statistical analysis (∗∗∗P < 0.001). The intergroups F_1 versus F_2 statistical analysis (∗∗P < 0.01) is also reported.
Figure 5
Figure 5
Ratio of probiotics of formulations (F_1 and F_2, versus F_3) by qPCR of species-specific sequences at the different times of treatment versus the amount at the baseline time point, expressed as bacterial counts. Upon the bars is reported the statistical analysis between treatments (∗∗∗P < 0.001).

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Source: PubMed

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