此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms

2026年9月28日 更新者:Xiuli Zuo、Shandong University

Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms: A Multidimensional Case-Control Study

The goal of this observational case-control study is to learn how stressful experiences, dietary habits, and blood nutrient levels are associated with gastrointestinal symptoms and symptoms of depression and anxiety in adults aged 18 to 65 years. The study will also examine whether positive psychological resources, such as hope, optimism, resilience, and self-confidence, are related to these associations.

The main questions this study aims to answer are:

  • Are stressful experiences in childhood and recent stressful life events associated with gastrointestinal symptoms and symptoms of depression and anxiety?
  • Are dietary habits and blood levels of selected nutrients associated with gastrointestinal and psychological symptoms?
  • Do psychological resources, such as hope, optimism, resilience, and self-confidence, influence the relationships among stress, nutrition, gastrointestinal symptoms, and psychological well-being?

Researchers will compare 100 participants with gastrointestinal disorders and psychological symptoms or a history of stress with 100 control participants who do not have chronic gastrointestinal symptoms and have low levels of depression and anxiety symptoms.

Participants will:

  • Complete questionnaires about stressful experiences, dietary habits, gastrointestinal symptoms, depression and anxiety symptoms, psychological resources, and quality of life.
  • Have gastrointestinal sounds recorded.
  • Allow blood remaining from routine clinical testing performed before endoscopy to be used to measure cholesterol, vitamin B6, and vitamin C levels. No additional blood draw will be required for this study.

All study assessments will be completed once at enrollment. There will be no follow-up visits, and participants will not receive or be assigned to any treatment as part of this study.

研究概览

研究类型

观察性的

注册 (估计的)

200

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population comprises adults aged 18-65 years of any sex. A total of 200 participants are planned: 100 cases with functional dyspepsia, gastroparesis, or irritable bowel syndrome, gastrointestinal symptoms lasting at least 3 months, and psychological symptoms or stress-related questionnaire scores meeting the protocol-defined thresholds; and 100 controls undergoing routine health examinations, without a history of these gastrointestinal disorders or chronic gastrointestinal symptoms, with depression and anxiety scores below the specified thresholds and no significant endoscopic abnormalities. Age and sex will be matched between groups where feasible. All participants must meet the eligibility criteria and provide written informed consent.

描述

Inclusion Criteria:

-

Case Group:

  1. Adults aged 18-65 years, of any sex.
  2. Functional dyspepsia, gastroparesis, or irritable bowel syndrome, with gastrointestinal symptoms lasting at least 3 months. Relevant symptoms include nausea, vomiting, postprandial fullness, early satiety, and bloating.
  3. At least one of the following psychological or stress-related criteria: Patient Health Questionnaire-9 (PHQ-9) score ≥5; 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥8; Self-Rating Anxiety Scale (SAS) score ≥50; Hamilton Anxiety Rating Scale (HAMA) score ≥7; Childhood Trauma Questionnaire (CTQ) total score ≥40; or Adolescent Self-Rating Life Events Checklist (ASLEC) total score ≥30.
  4. Upper gastrointestinal endoscopy and colonoscopy excluding organic gastrointestinal lesions, such as peptic ulcers, gastrointestinal tumors, or esophageal strictures.
  5. Voluntary participation and provision of written informed consent.

Control Group:

  1. Adults aged 18-65 years, of any sex, with age and sex matched to the case group where feasible.
  2. No history of functional dyspepsia, gastroparesis, or irritable bowel syndrome, and no chronic gastrointestinal symptoms, such as recurrent abdominal pain, bloating, nausea, or vomiting.
  3. All of the following: PHQ-9 score <5, HAMD-17 score <8, SAS score <50, and HAMA score <7.
  4. Undergoing routine health examinations, with no significant abnormalities on upper gastrointestinal endoscopy and colonoscopy.
  5. Voluntary participation and provision of written informed consent.

Exclusion Criteria:

-

The following exclusion criteria apply to both groups:

  1. Severe underlying disease, including severe hepatic or renal dysfunction (ALT/AST >3 times the upper limit of normal or serum creatinine >133 μmol/L), malignancy, severe coronary artery disease, or heart failure.
  2. Diagnosed organic gastrointestinal disease, including peptic ulcers, gastrointestinal tumors, inflammatory bowel disease, or intestinal obstruction.
  3. Previous gastrointestinal resection, except appendectomy.
  4. Use within the past month of medications affecting gastrointestinal motility, such as opioids, anticholinergics, or prokinetic agents, or medications substantially affecting metabolism, such as statins or systemic corticosteroids.
  5. Diagnosed severe psychiatric disorders, such as schizophrenia or bipolar disorder, or a suicide attempt or suicidal behavior within the past 6 months.
  6. Pregnancy or breastfeeding.
  7. Inability to understand the questionnaires or cooperate with completion of the assessments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
Case Group

Participants must meet at least one psychological or stress-related criterion: Patient Health Questionnaire-9 (PHQ-9) score ≥5, 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥8, Zung Self-Rating Anxiety Scale (SAS) score ≥50, Hamilton Anxiety Rating Scale (HAM-A) score ≥7, Childhood Trauma Questionnaire (CTQ) total score ≥40, or Adolescent Self-Rating Life Events Checklist (ASLEC) total score ≥30.

Control Group

Adults aged 18-65 years with no history of functional dyspepsia, gastroparesis, or irritable bowel syndrome and no chronic gastrointestinal symptoms. Participants must have PHQ-9 <5, HAMD-17 <8, SAS <50, and HAM-A <7, with no significant abnormalities on endoscopic examinations. Age and sex will be matched to the case group where feasible. All participants must provide written informed consent. Planned enrollment: 100 participants.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Gastrointestinal Symptom Severity Assessed by the Gastroparesis Cardinal Symptom Index (GCSI)
大体时间:At enrollment (single assessment)

Gastrointestinal symptom severity will be assessed using the Gastroparesis Cardinal Symptom Index (GCSI). The GCSI assesses three symptom domains: nausea/vomiting, postprandial fullness/early satiety, and bloating. The total GCSI score ranges from 0 to 5, with higher scores indicating greater gastrointestinal symptom severity.

At enrollment (single assessment)
Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9)
大体时间:At enrollment (single assessment)

Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with a total score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms.

At enrollment (single assessment)
Depressive Symptoms Assessed by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
大体时间:At enrollment (single assessment)

Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating greater severity of depressive symptoms.

At enrollment (single assessment)
Anxiety Symptoms Assessed by the Zung Self-Rating Anxiety Scale (SAS)
大体时间:At enrollment (single assessment)

Anxiety symptoms will be assessed using the Zung Self-Rating Anxiety Scale (SAS). The SAS consists of 20 items, with a total raw score ranging from 20 to 80. Higher scores indicate greater severity of anxiety symptoms.

At enrollment (single assessment)
Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A)
大体时间:At enrollment (single assessment)

Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAM-A). The scale consists of 14 items, with a total score ranging from 0 to 56. Higher scores indicate greater severity of anxiety symptoms.

At enrollment (single assessment)

次要结果测量

结果测量
措施说明
大体时间
Irritable Bowel Syndrome Symptom Severity Assessed by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
大体时间:At enrollment (single assessment)

Irritable bowel syndrome symptom severity will be assessed using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). The total score ranges from 0 to 500, with higher scores indicating greater severity of irritable bowel syndrome symptoms.

At enrollment (single assessment)
Quality of Life Assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire
大体时间:At enrollment (single assessment)

Quality of life will be assessed using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better disease-specific quality of life.

At enrollment (single assessment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅