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Randomized Controlled Trial
. 2017:2017:5650627.
doi: 10.1155/2017/5650627. Epub 2017 Sep 24.

Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety

Carmela Colica  1 , Ennio Avolio  2 , Patrizio Bollero  3 , Renata Costa de Miranda  4   5 , Simona Ferraro  6 , Paola Sinibaldi Salimei  7 , Antonino De Lorenzo  7 , Laura Di Renzo  7
Affiliations
Randomized Controlled Trial

Evidences of a New Psychobiotic Formulation on Body Composition and Anxiety

Carmela Colica et al. Mediators Inflamm. 2017.

Abstract

Background: Gut microbiota is implied in obesity, because of its ability to harvest energy from diet, and in the regulation of behavior. Given the link between gut microbiota, body composition, obesity, and anxiety, the aim of this study was to evaluate the effects of a new psychobiotic formulation.

Methods: Eligible patients were randomly divided into three groups: psychobiotics oral suspension group (POSG); dietary treatment group (DTG); combined treatment group (CTG). All subjects underwent body composition and psychological profile evaluation.

Results: Significant changes in body composition parameters in each group were relieved after all treatments. Hamilton anxiety rating scale (HAM-A) highlighted a significant reduction of the total score for all study population after treatments in POSG (p = 0.01) and CTG (p = 0.04). A reduction of HAM-A total score in anxious subjects in POSG or CTG and a significant reduction of positive subjects for HAM-A in POSG (p = 0.03) and in CDG (p = 0.01) were shown.

Discussion: Three-week intake of selected POS represents a good approach to solve problems related to obesity and behavior disorders. However, new clinical trials need to be performed on a larger population and for a longer period of treatment before definitive conclusions can be made. This trial is registered with NCT01890070.

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Figures

Figure 1
Figure 1
Study flow diagram according to Consort, 2010.
Figure 2
Figure 2
Hamilton anxiety rating scale (HAM-A) score variation before and after treatments in anxious and nonanxious subjects. Nonanxious subjects (negative test) if total score < 18 and anxious subjects (positive test) if total score ≥ 18. Variation score is shown as median, minimum, and maximum. 609 statistical significance attributed to results with p < 0.05 by Kruskal Wallis test. Anxious variation score among groups: p = 0.10 and nonanxious variation score among groups: p = 0.67. POSG: psychobiotics oral suspension group; DTG: dietary treatment group; CTG: combined treatment group.
Figure 3
Figure 3
Frequency change of anxious subjects in POSG, DTG, and CTG after treatment. Frequency of anxiety was evaluated before and after treatment in POSG, DTG, and CTG. Negative test (nonanxious 619 subjects) if total score < 18 and positive test (anxious subjects) if total score ≥ 18. Statistical significance attributed to results with ∗p < 0.05 between T0 and T1 by McNemar test. POSG:p = 0.03∗; DTG: p = 0.10; CTG: p = 0.01∗. POSG: psychobiotics oral suspension group; DTG: dietary treatment group; CTG: combined treatment group.
Figure 4
Figure 4
Gut-microbiota axis.
See this image and copyright information in PMC

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