Computational protocol: Open-label pilot for treatment targeting gut dysbiosis in myalgic encephalomyelitis/chronic fatigue syndrome: neuropsychological symptoms and sex comparisons

Similar protocols

Protocol publication

[…] Primary and secondary endpoints were the change in scores on psychological outcomes at post-intervention for the intention-to-treat (ITT) population (i.e., all participants who commenced at baseline). A priori allocation of primary outcome status was based on evidence from research indicating sensitivity measuring treatment effects in this [] and other clinical populations []. Primary outcome variables included a measure of sleep (actigraphic sleep efficiency; SE), mood (Profile of Mood States-Short Form Total Mood Disturbance, POMS []) and a measure of sustained visual attention (Rapid Visual Processing-A′, RVP-A′ from the Cambridge Neuropsychological Test Automated Battery, CANTAB []).Multiple secondary endpoints were selected to evaluate change in microbiota (Streptococcus, Bifidobacteria and Lactobacillus count and RA), urinary d-lactate (d:l lactate ratio) and clinical symptoms including: objective sleep symptoms [Actigraphy sleep onset latency (SOL), wake after sleep onset (WASO), and restlessness/sleep fragmentation index (SFI)]; subjective sleep symptoms (Sleep Diary SOL, WASO, SE, and the Pittsburgh Sleep Quality Index, PSQI—Global Score []); mood (Depression, Anxiety and Stress Scale, DASS-21 []); cognition (word memory, story memory, spatial working memory, visual learning, verbal fluency, processing speed, cognitive flexibility and planning); fatigue (General Fatigue subscale from the Multidimensional Fatigue Inventory, MFI-20 []); and the Brain Fog subscale of the Multiple Fatigue Types Questionnaire, MTFQ []); and total symptoms (Symptom Severity and Symptom Hierarchy Profile, SSH-Total score []).Uncertainty about the suitability of endpoints suggested a less hierarchical approach to outcome classification. Subsequently, the results of both primary and secondary outcome variables are presented together prioritising outcomes with large effect sizes (ES). [...] The study aimed to recruit equal proportions of males and females to conduct sex comparisons. Power analyses conducted by G*Power 3.1 indicated that the minimum sample size of n = 20 per group (alpha = .05, power = .8) would enable moderate to large ES estimates to achieve significance using analysis of variance (2 × 2 repeated measures ANOVA). A sample size of 40 for the combined group (alpha = .05, power = .8) was required to identify significant, moderate ES estimates using repeated measures ANOVA within factors (f = .23). […]

Pipeline specifications

Software tools CANTAB, G*Power
Applications Miscellaneous, Neuropsychology analysis
Organisms Homo sapiens
Diseases Nervous System Diseases, Fatigue Syndrome, Chronic
Chemicals Erythromycin, Lactic Acid