Crohn'sRecruiting

Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Not applicable · Testing dietary pattern and EEN · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing dietary pattern and EEN to improve how care is delivered. Condition(s) listed: Crohn Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 14 and older
Any sex

Some of the main requirements, copied from the record:

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

There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 35 participants are expected to take part.
Start date: 2022-09-17.
Main results expected around 2026-06-30 (estimate from the record).
1 study site listed (1 marked recruiting) in China.

Main thing being measured

Quality of Life(IBDQ) (The two groups of patients were scored at first week and sixth week after surgery.)

In the researchers’ words

Over the past 10 years, there are a large number of dietary treatments related to the CD, such as specific carbohydrate diet, low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) diet, and allergen-free foods. But there is no consistent conclusion or convincing evidence about the effectiveness.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Crohn Disease
Lead sponsor	Second Affiliated Hospital, Zhejiang University, School of Medicine
Enrollment	35 (estimated)
Start date	2022-09-17
Primary completion (est.)	2026-06-30
First posted	2022-08-16
Last updated	2026-02-02
Official title	Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery
ClinicalTrials.gov ID	NCT05502965

Interventions

dietary pattern (Other)
Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.
EEN (Other)
All energy and nutrients are obtained from exclusive enteral nutrition.

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou, Zhejiang	China	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.