This study looked at validated measures at weekly intervals and stool was collected from subjects at baseline, at the end of treatment and 2-3 months post treatment with the Neuraxis PENFS device for microbiome analysis.

Baseline findings

1. Clostridial species in the intestines that have been implicated in gastrointestinal pro-inflammatory states, were higher in children with IBS compared to healthy controls.
2. Microbial metabolic pathways involving long chain fatty acids were higher in children with IBS compared to healthy controls.

Post-PENFS treatment

1. Consistent with other studies, PENFS improved abdominal pain, functional disability, and pain catastrophizing in children with IBS.
2. Treatment with PENFS decreased intestinal Clostridial species in children with IBS.
3. At long-term follow-up, the active device group decreased to the minimal disability range, whereas the sham group remained in the moderate disability range.
4. Treatment with PENFS also decreased long chain fatty acid synthesis pathways.

Significance

1. Study validates previous studies with symptom improvement after 4 weeks of treatment.
2. Results add evidence that the microbiome and microbial metabolic pathways in children with IBS are different than healthy controls.
3. Study suggests that PENFS may have an additional benefit of altering the microbiome and/or microbial metabolic pathways through modulation of the brain-gut axis.