Clinical trial NCT05513040: Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
Official title: Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥ 18 years old who met criteria of functional dyspepsia defined by Rome IV were eligible for our study.

Brief summary: Functional dyspepsia (FD) is one of most common chronic gastrointestinal disorders. Several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of FD, including proton pump inhibitors (PPI), Tricyclic antidepressant and prokinetics. However, the clinical course of FD after taking medication-based treatment was unknown. Furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. Previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. However, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.


Eligibility criteria: Inclusion Criteria:

1. age ≥18 years old
2. Patients who met Rome IV criteria
3. Normal upper endoscopy and abdominal ultrasonography within one year

Exclusion Criteria:

1. Patients with local or systemic diseases which may cause dyspeptic symptoms:

   Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
2. organ failure defined by Marshall standard
3. severe psychiatric illnesses
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent
7. suspected or identified bowel obstruction

Primary outcomes:
measure: score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing symptom improvement at 6 months after the initial visit
timeFrame: 6 months
Secondary outcomes:
measure: subtypes of functional dyspepsia
timeFrame: 6 months
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1 day
measure: Hospital anxiety and depression scale
timeFrame: 1 day
measure: Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.
timeFrame: 1 day
measure: the change of Global Overall Symptom score (GOSS)
timeFrame: 1month, 3 months, 6 months,12 months
measure: Adequate relief rate
timeFrame: 1month, 3 months, 6 months,12 months
measure: the change of Functional dyspepsia symptom diary (FDSD) score
timeFrame: 1month, 3 months, 6 months,12 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing 986 Hospita
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References: