Evaluate the therapeutic efficacy of umbilical moxibustion therapy for IBS. Compare and analyze the differences in gut microbiota composition and diversity between the umbilical moxibustion group and the control group based on 16S sequencing.

Compare and analyze the metabolomic differences between the umbilical moxibustion group and the control group based on non-targeted metabolomics, and identify differential metabolites associated with umbilical moxibustion treatment for IBS.

Elucidate the role of the "gut microbiota-metabolite" interaction in the mechanism of umbilical moxibustion for treating IBS.

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized primarily by abdominal pain and altered bowel habits. The global prevalence of IBS is approximately 11.2%, while its incidence in China ranges from 2.3% to 15.8%, with IBS-D (diarrhea-predominant IBS) being the most common subtype. This condition is characterized by recurrent episodes and is often difficult to cure. Currently, the pathogenesis of IBS remains unclear. However, as research on gut microbiota advances, increasing evidence suggests that gut microbiota plays a significant role in the development, progression, and treatment of IBS. It can contribute to the occurrence of IBS by damaging the intestinal barrier, activating immune responses, and increasing visceral sensitivity, among other mechanisms. Clinically, umbilical moxibustion therapy, which involves stimulating the Shenque point, has shown good efficacy in treating IBS, though its underlying mechanisms remain unclear. Based on non-targeted metabolomics combined with 16S rRNA gene sequencing technology, this study aims to identify biomarkers and related metabolic pathways associated with umbilical moxibustion in the treatment of IBS. The goal is to preliminarily elucidate the molecular-level mechanisms underlying the therapeutic effects of umbilical moxibustion for IBS.

Study Type: Prospective, single-blinded, randomized controlled trial (patient-blinded, researcher-unblinded).

Sample Size: 60 cases (30 in the umbilical moxibustion group, 30 in the control group), determined using G*Power (effect size d = 0.8, α = 0.05, β = 0.2; with a minimum of 26 cases per group, 15% attrition rate reserved, final 30 cases per group).

Grouping Method: A random number table generated by SPSS 26.0 was used to allocate participants in a 1:1 ratio, with sealed envelopes employed to conceal group assignments.