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Study on novel biologic agents combined with improved oral enteral nutrition in the treatment of Crohn's disease

Study on novel biologic agents combined with improved oral enteral nutrition in the treatment of Crohn's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078221
Enrollment
Unknown
Registered
2023-12-01
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Experimental group:The treatment regimen for the experimental group was novel biologics plus total enteral nutrition (EEN) orally.
control group:The control group was treated with a novel biologic agent (ulinumab or Vederizumab)

Sponsors

Zhangzhou Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed Crohn's disease (CD) according to international diagnostic standards 2. Age 18-65 years old 3. CDAI score =150 at the time of enrollment, that is, they were in the active stage of disease 4.CD lesions involved the small intestine (at least the ileum) 5. No adjustment of CD medication regimen during treatment 6. The patient's clinical history and follow-up data were complete

Exclusion criteria

Exclusion criteria: Patients diagnosed with short bowel syndrome or with ileostomy or colostomy 2. There are EN contraindications, such as active gastrointestinal hemorrhage and intestinal obstruction 3. Patients who have used biologics within 60 days prior to enrollment or within 5 drug half-lives, whichever is longer 4. Patients with simple colon type CD 5. Patients with metabolic diseases, such as diabetes, hyperthyroidism, etc 6. Pregnant and nursing patients 7. Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental patients and serious diseases affecting their quality of life 8. Patients with severe active infection

Design outcomes

Primary

MeasureTime frame
Induced remission rate;Nutritional index;Quality of life score;

Countries

China

Contacts

Public ContactLin Han

Zhangzhou Affiliated Hospital of Fujian Medical University

hl964@sina.com+86 139 6017 2228

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026