Irritable Bowel Syndrome With DiarrheaNCT05311293
Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
An observational study of Irritable Bowel Syndrome With Diarrhea, run by Tang-Du Hospital at 1 site in China.
Trial summary
The research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Endoscopy
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome
Who may be able to join
- Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
- Aged between 18 and 65 years old (inclusive), male or female;
- HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points
Who cannot join
- Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
- Abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal, or T-Bil > 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
- Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
- Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
- Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
- Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;
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- Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
- 4. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
- 4. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
- 4. Use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics;
- Allergic constitution;
- Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and IBS, and discover potential targets for effective treatment. This project can help to construct the colonic single-cell map of IBS-D patients and explore the differentially expressed genes in the colon of IBS patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and IBS.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDiagnostic test
Observe the extent of colonic lesions and obtain intestinal mucosal samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with simple diarrhea-predominant irritable bowel syndrome | Not described Receives: Diagnostic Test: Endoscopy | |
| Patients with irritable bowel syndrome accompanied by anxiety and depression | Not described Receives: Diagnostic Test: Endoscopy | |
| Healthy Volunteers | Not described Receives: Diagnostic Test: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression Score
To evaluate the extent to which a disease affects a mental condition
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Nov 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311293
- Sponsor's protocol ID
- irritable bowel syndrome
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
- ClinicalTrials.gov ID
- NCT05311293
- Acronym / sponsor ID
- irritable bowel syndrome
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Apr 2022 (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 research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and IBS, and discover potential targets for effective treatment. This project can help to construct the colonic single-cell map of IBS-D patients and explore the differentially expressed genes in the colon of IBS patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and IBS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with simple diarrhea-predominant irritable bowel syndrome | – | Diagnostic Test: Endoscopy |
| Patients with irritable bowel syndrome accompanied by anxiety and depression | – | Diagnostic Test: Endoscopy |
| Healthy Volunteers | – | Diagnostic Test: Endoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome
Key inclusion criteria (3 listed)
- Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
- Aged between 18 and 65 years old (inclusive), male or female;
- HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points
Key exclusion criteria (12 listed)
- Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
- Abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal, or T-Bil > 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
- Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
- Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
- Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
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 |
|---|---|---|
| EndoscopyObserve the extent of colonic lesions and obtain intestinal mucosal samples | Diagnostic test | Healthy Volunteers, Patients with irritable bowel syndrome accompanied by anxiety and depression, Patients with simple diarrhea-predominant irritable bowel syndrome |
Primary outcome
Anxiety and Depression Score
Time frame: up to 100 weeks
To evaluate the extent to which a disease affects a mental condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 With Diarrhea, run by Tang-Du Hospital 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 3 inclusion and 12 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 5 Apr 2022. 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?
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?
Anxiety and Depression Score (time frame: up to 100 weeks). 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 5 Apr 2022.