Diet plan for Crohn's disease patients after bowel surgery

Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery

This tests a new, China-adapted dietary plan based on enteral nutrition to help people with Crohn's disease stay in remission after bowel surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05502965 on ClinicalTrials.gov

What this trial studies

This interventional program delivers a dietary therapy modeled on the nutrient composition of exclusive enteral nutrition but adapted to Chinese foods and cost constraints. It is offered to patients with Crohn's disease who have undergone bowel resection and can take oral nutrition after surgery. Participants follow the prescribed dietary pattern with clinical follow-up to monitor remission status, complications, and nutritional measures. The protocol excludes patients with stomas, obstructive strictures, significant comorbid autoimmune disease, extreme BMI values, or recent prolonged antibiotic/probiotic use.

Who should consider this trial

Good fit: Adults with Crohn's disease who have had bowel resection, can tolerate oral nutrition after surgery, and meet the study's BMI and medication-use criteria are the intended participants.

Not a fit: Patients with an ileostomy/colostomy, complete bowel obstruction or fibrous stricture, pregnancy/breastfeeding, planned imminent surgery or biologic/corticosteroid use, severe comorbid autoimmune disease, extreme BMI, or recent prolonged antibiotic/probiotic exposure are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the diet could help maintain postoperative remission and reduce the need for stronger medical therapies for some patients.

How similar studies have performed: Exclusive enteral nutrition is well-established for inducing remission—particularly in children—and other exclusionary or low-FODMAP dietary approaches have shown mixed results in adults, so this specific China-adapted pattern is relatively novel and incompletely tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnose CD according to endoscopy, histology and imaging;
2. Bowel resection for CD
3. Oral nutritional preparations or food can be given after surgery

Exclusion Criteria:

1. Plan operation within 5 weeks after surgery;
2. Presence of an ileostomy or colostomy
3. Complete bowel obstruction or fibrous stricture
4. Pregnancy or breastfeeding;
5. Plan to use biological agents within 5 weeks after surgery;
6. Plan to use corticosteroids or prednisone greater than 20 mg per day or equivalent doses of drugs to maintain remission within 5 weeks after surgery;
7. Plan to use probiotics or prebiotics for more than 1 week after surgery;
8. Antibiotics are used for more than 2 weeks after surgery;
9. Hypersensitivity to known components of enteral nutrition;
10. BMI less than 14 or greater than 28 kg/m2;
11. Celiac disease;
12. Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis;
13. Mental illness;
14. Malignant tumors
15. Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body)
16. Participating in other clinical trials
17. The researcher believes that others are not suitable to participate in this study.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: yu qiao — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: huang xiaoxu

Conditions Crohn Disease; Dietary Pattern, Crohn Disease