Mechanism of Umbilical Moxibustion in the Treatment of IBS-b

NCT ID: NCT07308262

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-targeted Metabolomics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Umbilical moxibustion

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

qingqing liu

Role: CONTACT

Phone: 13858089867

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY-2025-166

Identifier Type: -

Identifier Source: org_study_id