Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07308262

Mechanism of Umbilical Moxibustion in the Treatment of IBS-b

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical moxibustion

Diagnostic Test

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

Primary outcomes

  1. Obtain the original mass spectrometry data

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

qingqing liu

CONTACT

[email protected]

13858089867

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Non-targeted Metabonomics Combined With 16S Sequencing to Analyze the Mechanism of Umbilical Moxibustion in the Treatment of IBS-B

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.