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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.

調査の概要

状態

まだ募集していません

条件

研究の種類

観察的

入学 (推定)

200

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:CASE_CONTROL
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Gastrointestinal Symptom Severity Assessed by the Gastroparesis Cardinal Symptom Index (GCSI)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Irritable Bowel Syndrome Symptom Severity Assessed by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年9月23日

QC基準を満たした最初の提出物

2026年9月28日

最初の投稿 (実際)

2026年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • KYLL-2026-03(YJ)-063

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