Irritable Bowel SyndromeNCT02822677
A Cross-sectional Study on IBS Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions
An observational study of Irritable Bowel Syndrome, run by Hong Kong Baptist University at 1 site in China.
Trial summary
The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2016to 30 Jan 2017
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: IBS Patients
Who may be able to join
- 1) meet of diagnosis of IBS(ROME 4); 2) age of 18 to 65 years (inclusive); 3) IBS Symptom Severity Scale [17] (IBS-SSS) > 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period; 4) Normal colonic evaluation (colonoscopy or barium enema) within 5 years; 5) Written informed consent.
Who cannot join
- 1) pregnancy or breast-feeding; 2) medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases; 3) Having suicidal ideas or attempts or aggressive behavior; 4) Use of medications known to influence gastrointestinal transit.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Chinese Medicine, Hong Kong Baptist University
Hong Kong, Hong Kong
About this study
Official title: The Distribution of Irritable Bowel Syndrome (IBS) Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions Associated With IBS Subtypes
The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes.
Read the detailed description
It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes. The primary outcome will be the distribution of IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship between CM pattern and their microbiota and metabolic profiling. The relationship between IBS subtype distribution and other predetermined factors will be assessed, including gender, age, weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview for DSM-5 Disorders-(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed. After the collection of serum, urine and stool samples, bacterial total DNA will be extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA and BA profiles in serum and feces will be tested as well.
- Conditions
- Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.
Measured: one year
Secondary outcomes (3)
the Host-gut Microbiota Metabolic Interactions Associated with IBS Subtypes
Measured: one year
the Relationship Between CM Pattern and Their Microbiota
Measured: one year
the relationship between CM pattern and metabolic profiling
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start7 Jul 2016
- Primary completion16 Jan 2017
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 504 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
- Investigators
- Zhao-xiang Bian, PhD, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822677
- Sponsor's protocol ID
- HKBUIBS2016
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu S, Lyu J, Bao G, Zheng P, Li Y, Ning Z, Li B, Zhuang M, Wong HK, Wang M, Zeng Y, Zheng Y, Luo J, Liu Q, Zhang L, Lin C, Xiao H, Yuan CS, Wong HLX, Bian Z, Zhai L. Gut bacteria that produce fatty acid ethanolamides alleviate diarrhea-predominant IBS with insulin resistance. Cell Host Microbe. 2026 Jul 8;34(7):1350-1366.e8. doi: 10.1016/j.chom.2026.05.020. Epub 2026 Jun 19.
PubMed 42320473
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distribution of Irritable Bowel Syndrome (IBS) Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions Associated With IBS Subtypes
- ClinicalTrials.gov ID
- NCT02822677
- Acronym / sponsor ID
- HKBUIBS2016
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 4 Jul 2016 (estimated)
- 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.
The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes.
Detailed description
It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes. The primary outcome will be the distribution of IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship between CM pattern and their microbiota and metabolic profiling. The relationship between IBS subtype distribution and other predetermined factors will be assessed, including gender, age, weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview for DSM-5 Disorders-(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed. After the collection of serum, urine and stool samples, bacterial total DNA will be extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA and BA profiles in serum and feces will be tested as well.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBS Patients
Key inclusion criteria (1 listed)
- 1) meet of diagnosis of IBS(ROME 4); 2) age of 18 to 65 years (inclusive); 3) IBS Symptom Severity Scale [17] (IBS-SSS) > 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period; 4) Normal colonic evaluation (colonoscopy or barium enema) within 5 years; 5) Written informed consent.
Key exclusion criteria (1 listed)
- 1) pregnancy or breast-feeding; 2) medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases; 3) Having suicidal ideas or attempts or aggressive behavior; 4) Use of medications known to influence gastrointestinal transit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.
Time frame: one year
3 secondary outcomes
the Host-gut Microbiota Metabolic Interactions Associated with IBS Subtypes
Time frame: one year
the Relationship Between CM Pattern and Their Microbiota
Time frame: one year
the relationship between CM pattern and metabolic profiling
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Derived from this study: PubMed 42320473Xu S, Lyu J, Bao G, Zheng P, Li Y, Ning Z, Li B, Zhuang M, Wong HK, Wang M, Zeng Y, Zheng Y, Luo J, Liu Q, Zhang L, Lin C, Xiao H, Yuan CS, Wong HLX, Bian Z, Zhai L. Gut bacteria that produce fatty acid ethanolamides alleviate diarrhea-predominant IBS with insulin resistance. Cell Host Microbe. 2026 Jul 8;34(7):1350-1366.e8. doi: 10.1016/j.chom.2026.05.020. Epub 2026 Jun 19.
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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. This study is not recruiting at the moment.
Zhao-xiang Bian, PhD principal investigator
Hong Kong Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Hong Kong Baptist University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822677, which also lists 1 linked publication.
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 16 Aug 2017.