Actively Recruiting

Age: 18Years +
All Genders
ID05513040

Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment

Led by Air Force Military Medical University, China · Updated on 2025-04-16

300

Participants Needed

4

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Functional dyspepsia (FD) is a common long-lasting digestive disorder affecting many people. Researchers are studying the course of FD in patients receiving medication-based treatments, such as proton pump inhibitors, tricyclic antidepressants, and prokinetics. This observational study aims to understand how symptoms improve or persist over time and to explore clinical and psychological factors, like anxiety and sleep problems, that may influence treatment outcomes. The study is sponsored by Air Force Military Medical University, China. Participants with FD who meet specific criteria will be observed without receiving experimental treatment. Assessments include symptom scores, dyspepsia subtypes, anxiety and depression scales, quality of life questionnaires, and symptom diaries. The main measure is improvement in symptoms at six months, with follow-up assessments up to twelve months. There is no experimental intervention; instead, researchers track patients' responses to their usual medication-based care. During the study, participants will complete questionnaires and symptom diaries at various points, including one day, one month, three months, six months, and twelve months after their initial visit. Researchers will analyze these data to understand symptom changes and factors related to improvement or persistence of FD symptoms. Participants will be monitored for six months primarily, with some measures extending to one year, to assess their condition and quality of life while receiving standard medical care.

CONDITIONS

Brief Title

Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of functional dyspepsia according to Rome IV criteria
  • Normal upper endoscopy and abdominal ultrasound within the past year
Not Eligible

You will not qualify if you...

  • Presence of local or systemic diseases causing dyspeptic symptoms, such as active peptic ulcer, cholecystitis, gallstones, gastrointestinal obstruction, gastroparesis, liver or kidney injury, hematological abnormalities, endocrine or metabolic diseases, malignancy, cardiovascular or cerebrovascular diseases, or NSAID-associated dyspepsia
  • Organ failure as defined by Marshall standard
  • Severe psychiatric illnesses
  • Known malignancy
  • Pregnancy or lactation
  • Unable to provide consent
  • Suspected or identified bowel obstruction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 6 months to 12 months

Participants are observed to track the clinical course of functional dyspepsia and factors predicting outcomes while receiving medication-based treatment.

Visits at 1 month, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 4 locations

1

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Not Yet Recruiting

2

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710032

Not Yet Recruiting

3

Xijing 986 Hospita

Xi'an, Shaanxi, China, 710032

Not Yet Recruiting

4

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

Y

Yanglin Pan

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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