Irritable Bowel SyndromeIBSNCT06013410
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
A study testing colonoscopy in people with Irritable Bowel Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are: Question 1: the microbiome difference of the biofilm between IBS and healthy patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 15 May 2026
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- IBS patients with IV type; no abdominal surgery;
Who cannot join
- age <18 y;
- major disease;
- alcoholic addicted;
- antibiotic use in past 3 months;
- severe gastrointestinal disease
- severe cardiac disease;
Show all 11Show fewer
- pregnant;
- ICU in past 1 year;
- vegeterian;
- immune disease (SLE etc.)
- mental disease;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
WEI WEI
About this study
The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are:
Question 1: the microbiome difference of the biofilm between IBS and healthy patients.
Question 2: the metabolic product patterns between IBS and healthy patients.
Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination.
Researchers will compare the IBS and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- colonoscopy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyDiagnostic test
colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| IBS group | Experimental | patients diagnosed with IBS according to clinical presentations Receives: Diagnostic Test: colonoscopy |
| Healthy control group | No intervention | healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mirobiome difference of the fecal between IBS and health controls
16S rDNA sequencing will be applied in fecal samples all the above participants
Measured: Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
mirobiome difference of the fecal between IBS and health controls
16S rDNA sequencing will be applied in fecal samples all the above participants
Measured: Fecal samples will be collected 7 days after the colonoscopy test (T2)
Metabolic changes between IBS and Healthy controls
mucosal biopsy will be collected during the colonoscopy in each patients
Measured: 1 day biopsy will be collected during the colonoscopy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start25 Aug 2023 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013410
- Sponsor's protocol ID
- 2023-0381
- Acronym
- IBS
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share on request
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06013410
- Acronym / sponsor ID
- IBS / 2023-0381
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Hospital
- Study start
- 25 Aug 2023 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 28 Aug 2023 (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.
The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are:
Question 1: the microbiome difference of the biofilm between IBS and healthy patients.
Question 2: the metabolic product patterns between IBS and healthy patients.
Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination.
Researchers will compare the IBS and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS group | Experimental | Diagnostic Test: colonoscopypatients diagnosed with IBS according to clinical presentations |
| Healthy control group | No intervention | –healthy control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- IBS patients with IV type; no abdominal surgery;
Key exclusion criteria (11 listed)
- age <18 y;
- major disease;
- alcoholic addicted;
- antibiotic use in past 3 months;
- severe gastrointestinal disease
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 |
|---|---|---|
| colonoscopycolonoscopy | Diagnostic test | IBS group |
Primary outcome
mirobiome difference of the fecal between IBS and health controls
Time frame: Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
16S rDNA sequencing will be applied in fecal samples all the above participants
mirobiome difference of the fecal between IBS and health controls
Time frame: Fecal samples will be collected 7 days after the colonoscopy test (T2)
16S rDNA sequencing will be applied in fecal samples all the above participants
Metabolic changes between IBS and Healthy controls
Time frame: 1 day biopsy will be collected during the colonoscopy test
mucosal biopsy will be collected during the colonoscopy in each patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: Undecided. share on request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy in people with Irritable Bowel Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WEI WEI (15267175186, wwze@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mirobiome difference of the fecal between IBS and health controls (time frame: Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)). The study lists 3 primary outcomes in all. 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 28 Aug 2023.