Irritable Bowel Syndrome (IBS)NCT07852819
Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
An observational study of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia, run by Shandong University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Inflammatory Bowel Disease (IBD)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2027
- Phase
- Observational
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- -
- 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.
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- 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.
Who cannot join
- -
- 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.
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- 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.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Inflammatory Bowel Disease (IBD), Gastroparesis, Depressive Symptoms, Anxiety Symptoms
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Gastroparesis, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Severity Assessed by the Gastroparesis Cardinal Symptom Index (GCSI)
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.
Measured: At enrollment (single assessment)
Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: At enrollment (single assessment)
Depressive Symptoms Assessed by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
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.
Measured: At enrollment (single assessment)
Anxiety Symptoms Assessed by the Zung Self-Rating Anxiety Scale (SAS)
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.
Measured: At enrollment (single assessment)
Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A)
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.
Measured: At enrollment (single assessment)
Secondary outcomes (2)
Irritable Bowel Syndrome Symptom Severity Assessed by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
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.
Measured: At enrollment (single assessment)
Quality of Life Assessed by the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire
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.
Measured: At enrollment (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852819
- Sponsor's protocol ID
- KYLL-2026-03(YJ)-063
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No