Crohn's disease intestinal fibrosis
Conditions
Interventions
1:Infliximab
2:Infliximab+antibiotics
Fibrous intestinal stenosis group:N/A
Non fibrous intestinal stenosis group:N/A
Sponsors
Sichuan Academy of Medical Sciences. Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: [Part 1] Changes of intestinal flora in CD patients with fibrous intestinal stenosis Inclusion criteria: ? 18-60 years old ? Conforming to the diagnostic criteria of the Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018? Beijing) ? Not having received treatment with mesalazine, hormones, immunosuppressants, biological agents ? Not using drugs and foods that may affect intestinal flora within 3 months ? Obtaining informed consent. [Part II] Changes of intestinal flora in CD patients receiving infliximab treatment after initial diagnosis and their correlation with intestinal fibrosis Inclusion criteria: ? Age 18-60 years old ? Newly diagnosed CD patients who meet the diagnostic criteria of the Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018? Beijing) ? Crohn's activity index Best CDAI index = 221 ? There are high risk factors for poor prognosis (more than 2 of the following): the onset age is less than 40 years old, the first onset requires hormone treatment, with perianal lesions, intestinal involvement length more than 100 cm, with esophagus, stomach Duodenal lesions ? have not been treated with mesalazine, hormone, immunosuppressive agent or biological agent ? have not used drugs and food that may affect intestinal flora within 3 months ? have been diagnosed as no intestinal fibrosis or non-fibrous intestinal stenosis by MRE according to the diagnostic criteria of cross-sectional imaging ? have received infliximab treatment and obtained informed consent. [Part III] Effect of combination of individualized antibiotic treatment on CD patients with intestinal fibrosis during the initial diagnosis of infliximab treatment Inclusion criteria: newly diagnosed CD patients receiving infliximab treatment in the second part of the study
Exclusion criteria
Exclusion criteria: [Part 1] Changes of intestinal flora in CD patients with fibrous intestinal stenosis Exclusion criteria: ? history of gastrointestinal surgery ? tumor, serious endocrine, metabolic, systemic diseases, severe cardiovascular, liver and kidney dysfunction and other basic diseases ? infectious diseases confirmed by examination, including but not limited to bacteria, fungi, viruses, etc. ? pregnancy ? no informed consent [Part II] Changes of intestinal flora in CD patients receiving infliximab treatment after initial diagnosis and their correlation with intestinal fibrosis Exclusion criteria: ? history of gastrointestinal surgery ? tumor, serious endocrine, metabolic, systemic diseases, severe cardiovascular, liver and kidney dysfunction and other basic diseases ? infectious diseases confirmed by examination, including but not limited to bacteria, fungi, viruses, etc. ? pregnancy ? no informed consent [Part III] Effect of combination of individualized antibiotic treatment on CD patients with intestinal fibrosis during the initial diagnosis of infliximab treatment Exclusion criteria: ? antibiotic allergy ? without informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fecal flora;Intestinal stricture; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein;erythrocyte sedimentation rate;PC-III;Best CDAI;Fibronectin; | — |
Countries
China
Contacts
Public ContactXue Yang
Sichuan Academy of Medical Sciences. Sichuan Provincial People's Hospital
Outcome results
None listed