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A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease

A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058055
Enrollment
Unknown
Registered
2022-03-27
Start date
2022-04-01
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

Inflammatory bowel disease (IBD)

Interventions

Hemienteral nutrition group:adalimumab biological analogues combined with partial enteral nutrition therapy
Internal nutrition group:adalimumab combined with total enteral nutrition
The adamumab group:adalimumab

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. The patient was diagnosed with Crohn's disease according to the 2018 Chinese IBD Diagnosis and Treatment Guidelines; 3. Adamumab bioanalogues were prescribed for the first time; 4. Sign the informed consent of the experiment and be willing to participate; 5. No symptoms of gastrointestinal obstruction; 6. Nutritional risk was assessed by management risk screening (NRS2002I>3 points).

Exclusion criteria

Exclusion criteria: 1. Currently enrolled in or planning to participate in any other clinical studies; 2. The patient had contraindications to adalimumab therapy or enteral nutrition; 3. Pregnant patients; 4. Patients with other serious underlying diseases; 5. Poor compliance or drug intolerance; 6. Worsening of the disease; 7. Patients using other immunological agents or hormones.

Design outcomes

Primary

MeasureTime frame
The ratio of clinical response (CDAI decline >=100) to clinical remission (CDAI<150) was achieved;

Secondary

MeasureTime frame
Proportion of endoscopic remission;Changes in body mass index (BMI);

Countries

China

Contacts

Public ContactYu Jing

The First Affiliated Hospital of Shantou University Medical College

scorpiojing@139.com+86 13924781267

Outcome results

None listed

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