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临床试验/NCT07252427
NCT07252427招募中不适用

Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder

Fang Tang1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Gut microbiota composition and relative abundance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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:
  • •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.

排除标准

  • •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.

研究组 & 干预措施

IBD with Depressive Disorder Group

干预措施: Not applicable- observational study (Other)

IBD without Depressive Disorder Group

干预措施: Not applicable- observational study (Other)

Control Group

干预措施: Not applicable- observational study (Other)

结局指标

主要结局

Gut microbiota composition and relative abundance

时间窗: Baseline

The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.

次要结局

  • Metabolite profiles and relative abundance(Baseline)

研究者

发起方
Fang Tang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fang Tang

Doctor

Qianfoshan Hospital

研究点 (1)

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