Non-targeted MetabolomicsNCT07308262
Mechanism of Umbilical Moxibustion in the Treatment of IBS-b
An observational study of Non-targeted Metabolomics, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-targeted Metabolomics
- What is being tested?
- Umbilical moxibustion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study 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.
Study Type: Prospective, single-blinded, randomized controlled trial (patient-blinded, researcher-unblinded).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-targeted Metabonomics Combined With 16S Sequencing to Analyze the 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.
Read the detailed description
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
- Non-targeted Metabolomics
- Being tested
- Umbilical moxibustion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical moxibustionDiagnostic test
Elucidate the role of the "gut microbiota-metabolite" interaction in the mechanism of umbilical moxibustion for treating IBS
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-targeted MetabolomicsStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308262
- Sponsor's protocol ID
- KY-2025-166
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-targeted Metabonomics Combined With 16S Sequencing to Analyze the Mechanism of Umbilical Moxibustion in the Treatment of IBS-B
- ClinicalTrials.gov ID
- NCT07308262
- Acronym / sponsor ID
- KY-2025-166
- Conditions
- Non-targeted Metabolomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical moxibustionElucidate the role of the "gut microbiota-metabolite" interaction in the mechanism of umbilical moxibustion for treating IBS | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-targeted Metabolomics, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qingqing liu (13858089867, qingliuq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain the original mass spectrometry data (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.