IBD (general)Not yet recruiting

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

Observational · No treatment assigned · Sites not listed yet · Shandong University

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Irritable Bowel Syndrome (IBS), Functional Dyspepsia and Inflammatory Bowel Disease (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 to 65
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

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…
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.

Plus 6 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 200 participants are expected to take part.
The study has 2 groups.
Start date: 2026-09 (planned).
Main results expected around 2027-03 (estimate from the record).
No study sites are listed yet. Check the official record for contact details.

Groups in this study

Case Group
Control Group

Main thing being measured

Gastrointestinal Symptom Severity Assessed by the Gastroparesis Cardinal Symptom Index (GCSI) (At enrollment (single assessment))
Depressive Symptoms Assessed by the Patient Health Questionnaire-9 (PHQ-9) (At enrollment (single assessment))
Depressive Symptoms Assessed by the 17-Item Hamilton Depression Rating Scale (HAMD-17) (At enrollment (single assessment))

In the researchers’ words

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…

Words you might see

ULN: upper limit of normal: the top of the usual range for a lab test.
Colonoscopy: a camera exam of the large intestine (colon).
Endoscopy: a camera exam inside the digestive tract.
Stricture: a narrowing (of the bowel or of a bile duct).

General definitions, not specific to this trial.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Observational
Study type	Observational
Conditions	Irritable Bowel Syndrome (IBS); Functional Dyspepsia; Inflammatory Bowel Disease (IBD); Gastroparesis; Depressive Symptoms; Anxiety Symptoms
Lead sponsor	Shandong University
Enrollment	200 (estimated)
Start date	2026-09
Primary completion (est.)	2027-03
First posted	2026-10-01
Last updated	2026-10-01
Official title	Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms: A Multidimensional Case-Control Study
ClinicalTrials.gov ID	NCT07852819

Interventions

None listed

Full eligibility criteria (from the record)

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.

Locations (0)

No sites listed yet. The official record has contact information.

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.