Inflammatory Bowel Disease
Conditions
Brief summary
This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.
Interventions
DIETARY_SUPPLEMENTProbiotic
The experimental phase of the study lasts 8 weeks and each patient will be visited 4 times (January, March, June, and December).
DIETARY_SUPPLEMENTMaltodextrin
The experimental phase of this study had last 8 weeks and each patient will make 4 visits (January, March, June, and December).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be over 18 years old 2. Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -
Exclusion criteria
1. Does not meet the diagnostic criteria of CD 2. Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc 3. Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness 4. Patients with suspected cancer in their intestines 5. Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery) 6. There is currently an infection 7. He has had cancer in the last 5 years -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System | 12 months | The intestinal inflammation will be assessed using the Endoscopic Scoring System, which will be observed under endoscope at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI) | 8 weeks | The Crohn's Disease Activity Index (CDAI) was used to evaluate the disease severity of CD. The CDAI score ranges from 0 to 600, with higher scores indicating more severe disease. The index is calculated by combining the daily frequency of bowel movements, abdominal pain score (0-10), general well-being (0-7), and the presence of abdominal mass (0-2). Additionally, the Simple Endoscopic Score for Crohn's Disease (SES-CD) was used for endoscopic scores, which ranges from 0 to 42, with higher scores indicating more severe endoscopic findings. |
| Assessment of Intestinal Flora Changes Using 16S RNA Analysis | 8 weeks | Part of the intestinal fluid was collected under endoscope, and 16S RNA analysis was conducted to evaluate the changes in the intestinal flora composition. |
| Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers | 8 weeks | The inflammatory changes were detected by analyzing peripheral blood for specific inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and other relevant cytokines. |
| Disease progression | 8 weeks | The progress of the disease was assessed by collecting fecal samples to detect the change of calcarein |
Countries
China
Contacts
Primary ContactHuanhuan Chen, Doctor
Outcome results
None listed