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Efficacy and Safety of Crohn's Disease Exclusion Diet in Adults with Mild-to-Moderate Active Crohn's Disease: A Prospective Cohort Study

Efficacy and Safety of Crohn's Disease Exclusion Diet in Adults with Mild-to-Moderate Active Crohn's Disease: A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101578
Enrollment
Unknown
Registered
2025-04-27
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Mild to moderately active Crohn's disease in adults

Interventions

Control group:None
CDED+PEN group:None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients with mildly to moderately active CD (CDAI score of 150-450 and within 4 weeks* endoscopic manifestations or biochemical indicators suggestive of active disease (hsCRP>5mg/L or ESR>20mm/hour or FCalp>50 µg/g))*: For patients with recent changes in medication, endoscopic/biochemical results should be collected after 4 weeks of medication stabilization. 2. Age 18-70 years old; 3.CD Stable dose of related medications (5-ASA, biologics, immunosuppressants, etc.), no dose adjustment within 4 weeks prior to enrollment; 4. Understand and be willing to cooperate with the study and follow-up, and give oral or written informed consent. *: For patients with recent medication changes, endoscopic/biochemical results should be collected after 4 weeks of medication stabilization.

Exclusion criteria

Exclusion criteria: 1. Be pregnant or lactating; 2. Those with current disease in B2 (presence of fixed non-inflammatory stricture 1 or small bowel obstruction) or type B3; 3. Those who are intolerant to CDED essential foods or PEN; 4. Patients with severe vomiting, intractable diarrhea or short bowel syndrome; 5. Patients with current intestinal infection (positive stool culture or positive test for parasite or Clostridium difficile, or positive blood CMV-DNA); 6. Patients with only upper gastrointestinal tract involvement; 7. Patients with diabetes mellitus, renal insufficiency or hepatic insufficiency. 1: Only patients with ileocecal stenosis could be included in the study

Design outcomes

Primary

MeasureTime frame
Crohn's disease activity index;

Secondary

MeasureTime frame
Simple endoscopic score for Crohn's disease;

Countries

China

Contacts

Public ContactHong Yang

Peking Union Medical College Hospital

hongy72@163.com+86 10 69155014

Outcome results

None listed

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