Inflammatory Bowel DiseaseNCT07252427
Gut Microbiota in IBD With Comorbid Depressive Disorder
An observational study of Inflammatory Bowel Disease and Depressive Disorder, run by Fang Tang at 1 site in China.
Trial summary
Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Depressive Disorder
- What is being tested?
- Not applicable- observational study
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2025to 30 Nov 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with inflammatory bowel disease with or without comorbid depressive disorder, and control participants, recruited from the First Affiliated Hospital of Shandong First Medical University.
Who may be able to join
- IBD with Depressive Disorder Group:
- Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).
- History of depressive disorder diagnosis or previous use of antidepressant medications.
- Age ≥ 18 years.
- Willingness to participate and provision of written informed consent.
- IBD without Depressive Disorder Group:
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- Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).
- No history of depressive disorder diagnosis
- No previous use of antidepressant medications.
- Age ≥ 18 years.
- Willingness to participate and provision of written informed consent.
- Control Group:
- No history of inflammatory bowel disease, depressive disorder, or use of antidepressant medications.
- No gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal pain) within the past 3 months, and no history of gastrointestinal diseases.
- Age ≥ 18 years.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).
- Use of antibiotics or probiotic supplements within the past 6 months.
- Inability or difficulty in providing biological samples.
- Missing essential patient information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Fang Dr. Tang, MD, PhD, +86 053189268253, tangfangsdu@gmail.com
About this study
Official title: Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder
Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.
This study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that significantly impairs patients' quality of life. Depressive disorder is a common comorbidity in patients with IBD, and the coexistence of the two conditions can exacerbate disease burden and complicate treatment management. Increasing evidence suggests that both IBD and depressive disorder are closely related to alterations in the gut microbiome and metabolome; however, studies focusing on the comorbidity of these two conditions using multi-omics approaches remain limited.
This cross-sectional observational study aims to investigate the diversity and compositional changes of the gut microbiome and metabolome in patients with comorbid IBD and depressive disorder. Fecal, blood, and intestinal mucosal samples will be collected from three groups: (1) patients with IBD and comorbid depressive disorder, (2) patients with IBD without depressive disorder, and (3) control group. Through multi-omics analysis, the study seeks to identify specific microbial taxa and metabolites associated with the comorbidity of IBD and depressive disorder, uncover differential microbial and metabolic profiles among the three groups, and explore the potential molecular mechanisms underlying the interaction between intestinal inflammation and depressive symptoms. The findings are expected to provide a scientific basis for the development of novel diagnostic biomarkers and therapeutic strategies for IBD patients with comorbid depressive disorder.
- Conditions
- Inflammatory Bowel Disease, Depressive Disorder
- Being tested
- Not applicable- observational study
- Keywords
- Inflammatory Bowel Disease, Depressive Disorder, Comorbidity, Gut Microbiome, Metabolomics
- Medical subject headings
- Inflammatory Bowel Diseases, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
observational study with no assigned intervention
| Study group | Role | What they receive |
|---|---|---|
| IBD with Depressive Disorder Group | Not described Receives: Other: Not applicable- observational study | |
| IBD without Depressive Disorder Group | Not described Receives: Other: Not applicable- observational study | |
| Control Group | Not described Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition and relative abundance
The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.
Measured: Baseline
Secondary outcomes (1)
Metabolite profiles and relative abundance
The secondary outcome is the expression level and diversity of serum and fecal metabolites identified through untargeted metabolomics analysis, and their correlations with gut microbial composition.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start16 Mar 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fang Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fang Tang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252427
- Sponsor's protocol ID
- YXLL-KY-2024 (143)
- Status last verified
- Jan 2025
- First submitted
- 16 Nov 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder
- ClinicalTrials.gov ID
- NCT07252427
- Acronym / sponsor ID
- YXLL-KY-2024 (143)
- Conditions
- Inflammatory Bowel Disease, Depressive Disorder
- Keywords
- Inflammatory Bowel Disease, Depressive Disorder, Comorbidity, Gut Microbiome, Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fang TangUniversity, hospital or other
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 Nov 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.
Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.
This study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.
Detailed description
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that significantly impairs patients' quality of life. Depressive disorder is a common comorbidity in patients with IBD, and the coexistence of the two conditions can exacerbate disease burden and complicate treatment management. Increasing evidence suggests that both IBD and depressive disorder are closely related to alterations in the gut microbiome and metabolome; however, studies focusing on the comorbidity of these two conditions using multi-omics approaches remain limited.
This cross-sectional observational study aims to investigate the diversity and compositional changes of the gut microbiome and metabolome in patients with comorbid IBD and depressive disorder. Fecal, blood, and intestinal mucosal samples will be collected from three groups: (1) patients with IBD and comorbid depressive disorder, (2) patients with IBD without depressive disorder, and (3) control group. Through multi-omics analysis, the study seeks to identify specific microbial taxa and metabolites associated with the comorbidity of IBD and depressive disorder, uncover differential microbial and metabolic profiles among the three groups, and explore the potential molecular mechanisms underlying the interaction between intestinal inflammation and depressive symptoms. The findings are expected to provide a scientific basis for the development of novel diagnostic biomarkers and therapeutic strategies for IBD patients with comorbid depressive disorder.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD with Depressive Disorder Group | – | Other: Not applicable- observational study |
| IBD without Depressive Disorder Group | – | Other: Not applicable- observational study |
| Control Group | – | Other: Not applicable- observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel disease with or without comorbid depressive disorder, and control participants, recruited from the First Affiliated Hospital of Shandong First Medical University.
Key inclusion criteria (16 listed)
- Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).
- History of depressive disorder diagnosis or previous use of antidepressant medications.
- Age ≥ 18 years.
- Willingness to participate and provision of written informed consent.
- Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).
Key exclusion criteria (4 listed)
- Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).
- Use of antibiotics or probiotic supplements within the past 6 months.
- Inability or difficulty in providing biological samples.
- Missing essential patient information.
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 |
|---|---|---|
| Not applicable- observational studyobservational study with no assigned intervention | Other | Control Group, IBD with Depressive Disorder Group, IBD without Depressive Disorder Group |
Primary outcome
Gut microbiota composition and relative abundance
Time frame: Baseline
The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.
1 secondary outcome
Metabolite profiles and relative abundance
Time frame: Baseline
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 23 Jan 2026.
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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.
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, China
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 Inflammatory Bowel Disease and Depressive Disorder, run by Fang Tang 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 16 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition and relative abundance (time frame: Baseline). 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 23 Jan 2026.