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A prospective, randomized controlled study of shared decision-making improving efficacy in patients with irritable bowel syndrome-D

A prospective, randomized controlled study of shared decision-making improving efficacy in patients with irritable bowel syndrome-D

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073681
Enrollment
Unknown
Registered
2023-07-18
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritable bowel syndrome-D

Interventions

control group:Routine treatment

Sponsors

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old; 2. Those who meet the Rome IV diagnostic criteria for IBS-D and have a moderate or higher severity, i.e. an IBS Severity Scoring System (IBS-SSS) score of>=175 points; 3. Junior high school education or above; 4. The patient or family member has no language communication barriers; 5. Able to sign and provide written informed consent; 6. Patients who are willing to participate in SDM, but if assigned to the control group, can also cooperate with the doctor's decision; 7. I hope to receive treatment.

Exclusion criteria

Exclusion criteria: 1. After excluding organic factors, the patient decides not to treat temporarily, that is, patients with mild symptoms (IBS-SSS<175 points). 2. Serious comorbidities that affect medication (such as severe liver dysfunction, renal failure, and congestive heart failure); 3. The presence of celiac disease, IBD, and/or other organic gastrointestinal diseases; Or diseases that affect gastrointestinal motility (such as cholecystitis, pancreatitis, hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, but anxiety and depression are not excluded indicators). 4. Previous gastrointestinal malignancies and/or surgeries (excluding appendectomy or cholecystectomy with a surgical duration of more than 6 months prior to enrollment); 5. Pregnancy or lactation period; 6. Excessive drinking or drug use; 7. The drugs currently used include corticosteroids or anti-inflammatory drugs, proton pump inhibitors, and antibiotic therapy.

Design outcomes

Primary

MeasureTime frame
severity of irritable bowel symptoms;

Secondary

MeasureTime frame
evaluation of impact of disease and quality of life;evaluation of negative psychology;Evaluation of diagnosis and treatment process;

Countries

Beijing

Contacts

Public ContactDong Wu

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

wudong@pumch.cn+86 186 1267 1010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026