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. 2022 Jan;30(1):61-74.
doi: 10.1002/erv.2876. Epub 2021 Nov 30.

The effects of probiotics administration on the gut microbiome in adolescents with anorexia nervosa-A study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial

Eva-Maria Gröbner  1 , Michael Zeiler  1 , Florian Ph S Fischmeister  2   3 , Kathrin Kollndorfer  1 , Sonja Schmelz  1 , Andrea Schneider  1 , Nina Haid-Stecher  4 , Kathrin Sevecke  4 , Gudrun Wagner  1 , Lara Keller  5 , Roger Adan  6 , Unna Danner  7 , Annemarie van Elburg  7 , Benny van der Vijgh  7 , Karlijn Liselotte Kooij  7 , Serguei Fetissov  8 , Nadia A Andreani  9 , John F Baines  9 , Astrid Dempfle  10 , Jochen Seitz  5 , Beate Herpertz-Dahlmann  5 , Andreas Karwautz  1
Affiliations

The effects of probiotics administration on the gut microbiome in adolescents with anorexia nervosa-A study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial

Eva-Maria Gröbner et al. Eur Eat Disord Rev. 2022 Jan.

Abstract

Objective: Knowledge on gut-brain interaction might help to develop new therapies for patients with anorexia nervosa (AN), as severe starvation-induced changes of the microbiome (MI) do not normalise with weight gain. We examine the effects of probiotics supplementation on the gut MI in patients with AN.

Method: This is a study protocol for a two-centre double-blind randomized-controlled trial comparing the clinical efficacy of multistrain probiotic administration in addition to treatment-as-usual compared to placebo in 60 patients with AN (13-19 years). Moreover, 60 sex- and age-matched healthy controls are included in order to record development-related changes. Assessments are conducted at baseline, discharge, 6 and 12 months after baseline. Assessments include measures of body mass index, psychopathology (including eating-disorder-related psychopathology, depression and anxiety), neuropsychological measures, serum and stool analyses. We hypothesise that probiotic administration will have positive effects on the gut microbiota and the treatment of AN by improvement of weight gain, gastrointestinal complaints and psychopathology, and reduction of inflammatory processes compared to placebo.

Conclusions: If probiotics could help to normalise the MI composition, reduce inflammation and gastrointestinal discomfort and increase body weight, its administration would be a readily applicable additional component of multi-modal AN treatment.

Keywords: anorexia nervosa; gut microbiome; gut-brain axis; probiotics; randomized controlled trial.

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Conflict of interest statement

The authors declare no conflict of interest. ‘The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.’ All probiotics and placebos used have been bought (funded by the Austrian Science Foundation) from the company Allergosan Inc. and this company had no influence on any parts of the study.

Figures

FIGURE 1
FIGURE 1
Study design of the present study. Blinded: name of study sites
See this image and copyright information in PMC

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