Functional gastrointestinal disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ?Meeting the diagnostic criteria for functional dyspepsia or diarrhea-predominant irritable bowel syndrome as established by the Academic Committee of Rome IV in 2016. ?Falling within the age range of 18 to 75 years. ?Abstaining from the use of medications related to the treatment of the condition for at least one week prior to study entry, and not participating in concurrent studies. ?Voluntarily participating in the trial and providing informed consent personally. ?Maintaining a permanent residence in the treatment location, conducive to therapy and follow-up.
Exclusion criteria
Exclusion criteria: ?For participants with functional dyspepsia, patients with gastric or duodenal ulcers, erosions, reflux esophagitis, and other related conditions identified through gastroscopy; patients with gallbladder inflammation, gallstones, and hepatic, biliary, splenic, or pancreatic issues detected via abdominal ultrasonography. ?For individuals with diarrhea-predominant irritable bowel syndrome, patients with tumors and organic lesions in the gastrointestinal tract found through colonoscopy, such as pancreatitis, intestinal polyps (excluding those who have undergone polyp removal more than two weeks ago), diverticula, and a history of colon or rectal cancer, inflammatory bowel disease, or intestinal tuberculosis; those with a history of abdominal or pelvic surgery, such as cholecystectomy. ?Coexisting metabolic disorders affecting gastrointestinal motility, such as thyroid disorders and diabetes. ?Patients with tumors and organic lesions in the heart, liver, or kidneys, as well as individuals with mental health disorders. ?Pregnant or lactating women and female patients with recent plans for conception. ?Patients whose circumstances, as determined by the investigator, may lower the likelihood of successful enrollment or complicate their participation, such as frequently changing work environments that could lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall symptom response rate (participants with functional dyspepsia); Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score(participants with diarrhea-predominant irritable bowel syndrome); | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual symptom quantification and grading table for functional dyspepsia(participants with functional dyspepsia);Bristol Stool Form Scale (participants with diarrhea-predominant irritable bowel syndrome);SF-36 Quality of Life Scale;Electrogastrogram;Heart rate variability; Serum brain-gut peptide;Psychological state; | — |
Countries
China
Contacts
Wangjing Hospital, China Academy of Chinese Medical Sciences