- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07852819
Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
Inclusion Criteria:
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Case Group:
- Adults aged 18-65 years, of any sex.
- 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.
- 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.
- Upper gastrointestinal endoscopy and colonoscopy excluding organic gastrointestinal lesions, such as peptic ulcers, gastrointestinal tumors, or esophageal strictures.
- Voluntary participation and provision of written informed consent.
Control Group:
- Adults aged 18-65 years, of any sex, with age and sex matched to the case group where feasible.
- No history of functional dyspepsia, gastroparesis, or irritable bowel syndrome, and no chronic gastrointestinal symptoms, such as recurrent abdominal pain, bloating, nausea, or vomiting.
- All of the following: PHQ-9 score <5, HAMD-17 score <8, SAS score <50, and HAMA score <7.
- Undergoing routine health examinations, with no significant abnormalities on upper gastrointestinal endoscopy and colonoscopy.
- Voluntary participation and provision of written informed consent.
Exclusion Criteria:
-
The following exclusion criteria apply to both groups:
- 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.
- Diagnosed organic gastrointestinal disease, including peptic ulcers, gastrointestinal tumors, inflammatory bowel disease, or intestinal obstruction.
- Previous gastrointestinal resection, except appendectomy.
- 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.
- Diagnosed severe psychiatric disorders, such as schizophrenia or bipolar disorder, or a suicide attempt or suicidal behavior within the past 6 months.
- Pregnancy or breastfeeding.
- Inability to understand the questionnaires or cooperate with completion of the assessments.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
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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. |
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gastrointestinal Symptom Severity Assessed by the Gastroparesis Cardinal Symptom Index (GCSI)
Časové okno: At enrollment (single assessment)
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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)
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Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Časové okno: At enrollment (single assessment)
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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)
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Depressive Symptoms Assessed by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
Časové okno: At enrollment (single assessment)
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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)
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Anxiety Symptoms Assessed by the Zung Self-Rating Anxiety Scale (SAS)
Časové okno: At enrollment (single assessment)
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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)
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Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A)
Časové okno: At enrollment (single assessment)
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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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Irritable Bowel Syndrome Symptom Severity Assessed by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Časové okno: At enrollment (single assessment)
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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)
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Quality of Life Assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire
Časové okno: At enrollment (single assessment)
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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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Neurologické projevy
- Duševní poruchy
- Střevní nemoci
- Symptomy chování
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Onemocnění žaludku
- Onemocnění tlustého střeva
- Gastroenteritida
- Onemocnění tlustého střeva, funkční
- Ochrnutí
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Syndrom dráždivého tračníku
- Úzkostné poruchy
- Deprese
- Zánětlivá onemocnění střev
- Gastroparéza
Další identifikační čísla studie
- KYLL-2026-03(YJ)-063
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