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

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.

The effects of polyunsaturated fatty acid (PUFA) administration on the microbiome-gut-brain axis in adolescents with anorexia nervosa (the MiGBAN study): study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial

“…The study is part of the international ERA-NET NEURON consortium “Microbiome Gut-Brain interaction in Anorexia Nervosa” (MiGBAN) with researchers from The Netherlands, Austria, France, and Germany. Another interventional study with a parallel study design will take place in Austria (Department of Child and Adolescent Psychiatry, Vienna General Hospital) with a supplementation of probiotics instead of PUFA [ 26 ].…”

Psychobiotics: the Influence of Gut Microbiota on the Gut-Brain Axis in Neurological Disorders

“…Gröbner et al assayed the efficacy of probiotics administration on AN patients and measured the body mass index (BMI), psycho/neuro psychological parameters by analyzing serum and stool samples. They reported positive regulation of gut microbial community in AN to improve weight gain, gastrointestinal discomfort, and inflammation reduction (Gröbner et al 2022 ). Liu et al evaluated the effects of probiotics on AN model by pre (fructooligosaccharides (FOS), 1.67 g/daily) and probiotic ( Saccharomyces boulardii (5 × 10 8 CFU)) intervention.…”

A critical analysis of eating disorders and the gut microbiome

“…In rat models of binge eating and anxiety behaviour, the selective administration of Bacteroides uniformis CECT 7771 results in cessation of binge eating and a reduction in anxiety-behaviour [62]. Additionally, randomized control trial comparing the effects of probiotics vs. placebo on 60 adolescent inpatients (ages [13][14][15][16][17][18][19] with AN has been planned and the results will glean insight on how probiotics may influence weight gain, ED pathology, and neuropsychological symptoms in adolescents [63]. Like the potential role of FMT to leverage the gut microbiome in ED treatment, probiotic supplementation is an exciting and promising avenue of research.…”