Inflammatory bowel disease
Conditions
Interventions
Placebo-controlled group:The placebo control group took 3 mg of placebo tablets of the same size, shape, color, and smell every night at bedtime for three months.
Melatonin intervention group:The intervention group was given melatonin tablets 3mg 2-3 hours before bedtime every night for three months.
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.According to the diagnostic criteria in the 'Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023)' and 'Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023)', combined with clinical, laboratory, imaging, endoscopic, and histopathological manifestations, a comprehensive analysis was conducted to determine patients diagnosed with UC or CD based on the exclusion of infectious and other non infectious colitis; 2.Age range: 18-80 years old, male or female not limited; 3.Poor sleep quality/sleep disorders: PSQI score greater than 5 points; 4.Complete clinical data, including patient general information, clinical symptoms, laboratory tests (blood routine, biochemistry, immunity, inflammation and infection indicators), auxiliary examinations (abdominal imaging, endoscopy), etc; 5.Disease activity in remission or mild to moderate activity: UC patients with Mayo score<3 or 3-10, CD patients with simplified CDAI score 0-4 or 5-8; 6.Having follow-up conditions: able to provide long-term feedback on diet and survey questionnaires through the APP.
Exclusion criteria
Exclusion criteria: 1.History of mental illness and cognitive impairment; 2.Individuals with a history of gastrointestinal surgery or malignant tumors, active infections, severe respiratory or cardiovascular diseases, and acute or chronic kidney disease; 3.Pregnant and breastfeeding patients; 4.There are known intestinal diseases such as celiac disease, or uncontrolled major chronic diseases such as cerebral infarction, cancer, heart failure, etc; 5.Currently using anticoagulants, melatonin, iron, antioxidants, estrogen, and sedative hypnotic drugs; 6.Individuals with decreased liver and kidney function or autoimmune diseases, such as systemic lupus erythematosus; 7.Patients or their families who cannot understand the conditions and objectives of this study and do not agree to follow-up; 8.Patients who have taken antibiotics, probiotics/prebiotics, and proton pump inhibitors in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Quality;Quality of life;Disability situation;Hospitalization, surgery, medication upgrade, new complications;Gut microbiota and metabolites; | — |
Countries
China
Contacts
Public ContactHong Yang
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed