About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Umbilical moxibustion
Diagnostic testElucidate the role of the "gut microbiota-metabolite" interaction in the mechanism of umbilical moxibustion for treating IBS
Treatment groups
Trial outcomes
Primary outcomes
Obtain the original mass spectrometry data
Obtain the original mass spectrometry data from metabolomics analysis, screen for differentially expressed small-molecule metabolites (meeting criteria: VIP \> 1, adjusted P-value \< 0.05, and fold change \> 1.5), and identify no fewer than 5 potential biomarkers associated with umbilical moxibustion in the treatment of IBS-D
Locations
Sponsors and contacts
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