inflammatory bowel disease
Conditions
Interventions
UC therapy + ProBio-Fit:Probio-Fit
UC trerapy + placebo: placebo
CD therapy + ProBio-Fit :ProBio-Fit
CDtrerapy + placebo:placebo
Sponsors
Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign informed consent; 2. Age 18-60, male or female; 3. Clinical diagnosis of UC/CD requires hospitalization.
Exclusion criteria
Exclusion criteria: 1.women trying to become pregnant, pregnant or breastfeeding women; 2.allergic to powder or ingredients; 3.have taken probiotics in the last 2 weeks; 4.Persons with known cardiovascular disease and renal insufficiency, malignant neoplasms, infectious and other digestive diseases, diabetes or autoimmune diseases, and other serious medical conditions deemed unsuitable for inclusion by the investigator; 5.patients with a history of abdominal surgery; 6.Those who have taken anti-anxiety, anti-depression and other psychotropic drugs in the past one month; 7.subjects with major mental disorders, difficulty in controlling their own actions and inability to cooperate; 8.Subjects who are unwilling to provide personal information and do not wish to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UCDAI/CDAI scores were used to evaluate the severity of IBD patients;Enteroscopy results to determine the patient's gastrointestinal ulcer; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of ProBio-FIT powder on blood metabolites of patients was analyzed by untargeted and targeted metabolomics ;Enzyme-linked immunosorbent assay (ELISA) was used to evaluate the effect of proBio-FIT powder on inflammatory factors in patients ;The effects of ProBio-FIT on intestinal metabolites of patients were analyzed by untargeted and targeted metabolomics ;The effects of proBio-FIT powder on intestinal flora and mucosal flora of patients were analyzed by metagenomic sequencing.;The effect of proBio-FIT powder on tissue lesions was evaluated by colonoscopy;Probio-fit's effect on patients' quality of life and mood was assessed by quality of Life Scale (IBDQ) ;Probio-fit's effect on patients' quality of life and mood was evaluated by the Hamilton Anxiety Scale (HAMA); | — |
Countries
China
Contacts
Public ContactChen Ping
Outcome results
None listed