Mechanism of Umbilical Moxibustion in the Treatment of IBS-b

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Umbilical moxibustion

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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