Crohn DiseaseNCT05502965
Specific Dietary Pattern for Crohn's Disease Patients Following Surgery
A study testing dietary pattern and EEN in people with Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- dietary pattern and EEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnose CD according to endoscopy, histology and imaging;
- Bowel resection for CD
- Oral nutritional preparations or food can be given after surgery
Who cannot join
- Plan operation within 5 weeks after surgery;
- Presence of an ileostomy or colostomy
- Complete bowel obstruction or fibrous stricture
- Pregnancy or breastfeeding;
- Plan to use biological agents within 5 weeks after surgery;
- 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;
Show all 17Show fewer
- Plan to use probiotics or prebiotics for more than 1 week after surgery;
- Antibiotics are used for more than 2 weeks after surgery;
- Hypersensitivity to known components of enteral nutrition;
- BMI less than 14 or greater than 28 kg/m2;
- Celiac disease;
- Complicated with other autoimmune diseases such as diabetes or rheumatic disease, autoimmune liver disease, psoriasis;
- Mental illness;
- Malignant tumors
- Those who are not suitable for body composition analysis (such as pacemakers and metal objects in the body)
- Participating in other clinical trials
- The researcher believes that others are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
huang xiaoxu
About this study
Official title: Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery
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. Through the long-term clinical experience observation, we find most of the CD patients can get stable remission by removing refined food and intolerance food.This project aims at developing a new dietary therapy suitable for Chinese patients.
Read the detailed description
The dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with Chinese patients' dietary habits and economic conditions.
- Conditions
- Crohn Disease
- Being tested
- dietary pattern, EEN
- Keywords
- Dietary Pattern, Crohn Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary patternOther
Also called dietary guidance
Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.
EENOther
All energy and nutrients are obtained from exclusive enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Enteral Nutrition(EEN) | Active comparator | Subjects required exclusive enteral nutrition for one month Receives: Other: EEN |
| Specific Diet+ Partial Enteral Nutrition | Experimental | Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month Receives: Other: dietary pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life(IBDQ)
IBDQ: Inflammatory Bowel Disease Questionnaire.The IBDQ evaluates the quality of life of patients from four aspects: intestinal symptoms, systemic symptoms, emotional function and social function. There are 32 questions in the questionnaire, with a total score of 32 to 224 points. The higher the score, the higher the quality of life of the patient.
Measured: The two groups of patients were scored at first week and sixth week after surgery.
Secondary outcomes (2)
nutritional status of the patient
Body composition analysis, calf circumference in centimeter , albumin in g/L, hemoglobin in g/L, were measured to evaluate the nutritional status
Measured: The two groups were evaluated at first week and sixth week after surgery.
Disease-related evaluation indicators
We assessed the effect of the intervention on disease by measuring the following indicators: Harvey-Bradshaw Index(HBI), Crohn's Disease Activity Index (CDAI), C Reactive Protein (CRP)in mg/L, Erythrocyte Sedimentation Rate (ESR) in mm/h, platelets in 10^9/L, triglycerides in m mol/L, cholesterol in m mol/L , uric acid in u mol/L.
Measured: The two groups were evaluated at first week and sixth week after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start17 Sep 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yu qiao, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Chinaguo huilan, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502965
- Sponsor's protocol ID
- 2022-0454
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Pathogenesis of Specific Dietary Pattern in Maintaining Remission Among Crohn's Disease(CD) Patients Following Surgery
- ClinicalTrials.gov ID
- NCT05502965
- Acronym / sponsor ID
- 2022-0454
- Conditions
- Crohn Disease
- Keywords
- Dietary Pattern, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Through the long-term clinical experience observation, we find most of the CD patients can get stable remission by removing refined food and intolerance food.This project aims at developing a new dietary therapy suitable for Chinese patients.
Detailed description
The dietary therapy is based on the nutrient composition of exclusive enteral nutrition and is more in line with Chinese patients' dietary habits and economic conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive Enteral Nutrition(EEN) | Active comparator | Other: EENSubjects required exclusive enteral nutrition for one month |
| Specific Diet+ Partial Enteral Nutrition | Experimental | Other: dietary patternSubjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnose CD according to endoscopy, histology and imaging;
- Bowel resection for CD
- Oral nutritional preparations or food can be given after surgery
Key exclusion criteria (17 listed)
- Plan operation within 5 weeks after surgery;
- Presence of an ileostomy or colostomy
- Complete bowel obstruction or fibrous stricture
- Pregnancy or breastfeeding;
- Plan to use biological agents within 5 weeks after surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary patternAlso: dietary guidanceReprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects. | Other | Specific Diet+ Partial Enteral Nutrition |
| EENAll energy and nutrients are obtained from exclusive enteral nutrition. | Other | Exclusive Enteral Nutrition(EEN) |
Primary outcome
Quality of Life(IBDQ)
Time frame: The two groups of patients were scored at first week and sixth week after surgery.
IBDQ: Inflammatory Bowel Disease Questionnaire.The IBDQ evaluates the quality of life of patients from four aspects: intestinal symptoms, systemic symptoms, emotional function and social function. There are 32 questions in the questionnaire, with a total score of 32 to 224 points. The higher the score, the higher the quality of life of the patient.
2 secondary outcomes
nutritional status of the patient
Time frame: The two groups were evaluated at first week and sixth week after surgery.
Disease-related evaluation indicators
Time frame: The two groups were evaluated at first week and sixth week after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yu qiao principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
guo huilan study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary pattern and EEN in people with Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact huang xiaoxu (+86-0571-87783851, xiaoxuhuang0909@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life(IBDQ) (time frame: The two groups of patients were scored at first week and sixth week after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.