Functional constipation
Conditions
Interventions
Placebo group:Resistant dextrin
Multi-strain probiotic group:Multi-strain probiotic intervention
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–60 years, male or female; 2.Meet the Rome IV diagnostic criteria for functional constipation: symptoms lasting >=3 months, defecation less than 3 times per week accompanied by straining during defecation; 3.Signed written informed consent;
Exclusion criteria
Exclusion criteria: 1.Organic intestinal diseases (e.g., colon cancer, inflammatory bowel disease, etc.); 2.Subjects with gastrointestinal bleeding; 3.Subjects with a history of gastrointestinal surgery; 4.Pregnant or lactating women; 5.Subjects who have taken antibiotics or probiotics within the past 1 month; 6.Subjects receiving concomitant medications known to affect gastrointestinal motility; 7.Subjects with psychiatric or cognitive disorders; 8.Subjects who fail to consume the test product as required or miss scheduled follow-up visits, making efficacy evaluation unfeasible; 9.Any other subjects deemed unsuitable for participation by the investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of subjects with functional constipation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Stool Form Scale Score;Gut microbiota;Patient Assessment of Constipation-Quality of Life (PAC-QOL) Score; | — |
Countries
China
Contacts
Public ContactTao Zhou
Qilu Hospital of Shandong University
Outcome results
None listed