Functional Constipation
Conditions
Interventions
Experimental group:Administration of Psyllium Husk
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 60 years old (inclusive); 2.Meet the Rome IV diagnostic criteria for functional constipation; 3.No anxiety (SAS self-rating scale score < 50), no depression (SDS self-rating scale score < 53), and no history of definite insomnia (PSQI score < 10); 4.Have not taken medications affecting bile acid metabolism (such as laxatives, prokinetics, cholestyramine, broad-spectrum antibiotics, probiotics preparations, traditional Chinese medicine related to cholagogue or containing relevant ingredients, or bile acid-promoting drugs) in the past 2 weeks; 5.Willing and able to sign the informed consent form, and able to comply with follow-up, sampling, and other study requirements.
Exclusion criteria
Exclusion criteria: 1.Have definite organic abdominal lesions or definite abdominal symptoms (unexplained abdominal pain, nausea, vomiting, diarrhea, acute abdominal diseases, colorectal tumors, inflammatory bowel disease, gastrointestinal perforation or risk of perforation, intestinal obstruction or suspected obstruction, symptomatic stricture, or history of organic intestinal diseases indicated by colonoscopy or imaging); 2.Have severe systemic diseases or conditions that may significantly affect the digestive system and gut microbiota (such as diabetes, Parkinson's disease, severe cardiovascular and cerebrovascular diseases, hepatic or renal insufficiency, cancer, thyroid dysfunction, mental illness, cirrhosis, renal failure, or hematopoietic system diseases); 3.Have long-term abnormal dietary or drinking habits (e.g., high-fat diet, vegetarian diet); 4.Pregnant or lactating women; 5.Have undergone surgeries that may affect intestinal function or bile acid metabolism; 6.Taking medications that may affect bile acid metabolism and gut microbiota (such as cholestyramine, broad-spectrum antibiotics, probiotics preparations, or high-dose bile acid-promoting drugs); 7.Allergic or intolerant to psyllium husk or its components; 8.Unable to comply with the study requirements or refuse to provide necessary samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constipation Scoring System (CSS) and Spontaneous Bowel Movements (SBM) per week;Concentrations of serum and fecal bile acid subtypes, and serum C4 concentration;Gut microbiota Alpha diversity (Shannon index, Chao1 index) and relative abundance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, type, and severity of adverse events; | — |
Countries
China
Contacts
Public ContactWang Yang
The First Hospital of Hebei Medical University
Outcome results
None listed