chronic constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be considered eligible for study participation if they meet the following inclusion criteria: 1. Male and female subjects, aged 18-65 years; 2. Meet the Rome IV diagnostic criteria; 3. Patients with chronic constipation (disease duration more than 6 months, less than 3 bowel movements per week and/or Bristol scale types 1 and 2); 4. Patients who understand clinical research and are committed to complying with study requirements and procedures; 5. Patients who have signed informed consent.
Exclusion criteria
Exclusion criteria: Patients will not be eligible for study enrollment if they have one or more of the following criteria: 1. Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or hepatic diseases known to be associated with alterations in the gut microbiota; 2. Pregnant or lactating patients; 3. The patient has taken antimicrobials, probiotics, or drugs that inhibit gastric acid or gastrointestinal motility in the past 6 weeks; 4. Patients who changed their diet type during the study; 5. Patients who are allergic to or intolerant to any ingredient in the preparation of the study product; 6. Patients with serious diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, endocrine diseases and mental diseases; 7. Stop taking the test sample or take other drugs in the middle of the course, and the efficacy cannot be judged or the data are incomplete; 8. In a short period of time, taking items related to the test function will affect the judge of the results; 9. In the investigator's judgment, the subject's condition does not qualify him or her to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve the symptoms of chronic constipation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Assessment of Constipation Symptom (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QoL) of patients were evaluated by questionnaire;To evaluate the effect of probiotics on intestinal flora in patients with chronic constipation;To evaluate the effect of probiotics administration on other clinical parameters;Serological indicators of the determination of concentrations, including IL-6; | — |
Countries
China
Contacts
Suzhou Ninth People's Hospital