Safety, tolerability, and preliminary effects of cricket chitin for adults with IBS: a double-blind randomized crossover pilot trial

Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder affecting around 11% of the global population. Increased production of inflammatory mediators and altered gut microbiota are common with IBS, and evidence suggests these factors are integral to IBS pathophysiology. Prebiotic dietary fiber interventions are being investigated to improve functional gastrointestinal symptoms by remediating gut microbiota and reducing intestinal inflammation. <i>Objective</i>: To investigate the safety and tolerability of a unique and sustainable fiber source, cricket-derived chitin, in a sample of adults (<i>n</i> = 18) diagnosed with IBS, and to gather preliminary data regarding IBS symptoms, inflammatory biomarkers, and gut microbiota to power future randomized, controlled trials. <i>Methods</i>: In this randomized, double-blind, 2 × 2 crossover pilot intervention, participants consumed cacao patties containing either 4 grams of cricket-derived chitin (<i>n</i> = 10) or a maltodextrin comparator (<i>n</i> = 8) daily for 30 days, followed by a 14 day washout period and additional 30 day intervention period where participants engaged in in the opposite intervention group. The primary outcome of safety and tolerability (<i>e.g.</i>, adverse events monitoring, physiologic and metabolic biomarkers, quality of life) and secondary outcomes (<i>e.g.</i>, inflammatory biomarkers, gastrointestinal symptoms, stool consistency, and gut microbiota) were assessed before and after each intervention. <i>Results</i>: All safety and tolerability criteria were met. Additionally, while participants reported improved GI symptoms following both treatments (<i>p</i> < 0.05), the relationship was more pronounced following the chitin intervention (<i>p</i> < 0.01); on average, the chitin treatment resulted in a significantly greater reduction in serum TNF-alpha than the comparator group by 47.41% (95% CI: -90.37, -4.44; <i>p</i>-value = 0.0350). Both interventions resulted in differentially abundant microbial taxa. <i>Conclusions</i>: Results suggest that while both chitin and cacao may be safe and tolerable in individuals with IBS and support symptom management, the chitin additive may provide an additional benefit for lowering inflammatory cytokines. This trial is registered on Clinicaltrials.gov (NCT06397924) and funded by a Colorado Agricultural Experiment Station grant.