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Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

dietary pattern

EEN

About this trial

This is an interventional health services research trial for Crohn Disease focused on measuring Dietary Pattern, Crohn Disease

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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;
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.

Sites / Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exclusive Enteral Nutrition(EEN)

Specific Diet+ Partial Enteral Nutrition

Arm Description

Subjects required exclusive enteral nutrition for one month

Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05502965

First Posted

August 11, 2022

Last Updated

February 1, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05502965

Brief Title

Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

Dietary Pattern, Crohn Disease

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exclusive Enteral Nutrition(EEN)

Arm Type

Active Comparator

Arm Description

Subjects required exclusive enteral nutrition for one month

Arm Title

Specific Diet+ Partial Enteral Nutrition

Arm Type

Experimental

Arm Description

Subjects received partial enteral nutrition with remaining energy and nutrients obtained through diet for one month

Intervention Type

Other

Intervention Name(s)

dietary pattern

Other Intervention Name(s)

dietary guidance

Intervention Description

Reprocessed and intolerant foods were removed from the dietary pattern, and the food were cooked at home for experimental subjects.

Intervention Type

Other

Intervention Name(s)

EEN

Intervention Description

All energy and nutrients are obtained from exclusive enteral nutrition.

Primary Outcome Measure Information:

Title

Quality of Life(IBDQ)

Description

Time Frame

The two groups of patients were scored at first week and sixth week after surgery.

Secondary Outcome Measure Information:

Title

nutritional status of the patient

Description

Body composition analysis, calf circumference in centimeter , albumin in g/L, hemoglobin in g/L, were measured to evaluate the nutritional status

Time Frame

The two groups were evaluated at first week and sixth week after surgery.

Title

Disease-related evaluation indicators

Description

Time Frame

The two groups were evaluated at first week and sixth week after surgery.

Other Pre-specified Outcome Measures:

Title

dietary compliance

Description

Modified medication adherence was measured, with < 6 points defined as low adherence, 6 to 8 points defined as moderate adherence, and > 8 points defined as high adherence

Time Frame

The two groups were evaluated at sixth week after surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

huang xiaoxu

Phone

+86-0571-87783851

xiaoxuhuang0909@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

lu yanyu

Phone

+86-0571-87783851

luyanyu@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yu qiao

Organizational Affiliation

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

guo huilan

Organizational Affiliation

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Official's Role

Study Director

Facility Information:

Facility Name

2nd Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

huang xiaoxu

12. IPD Sharing Statement

Plan to Share IPD

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Specific Dietary Pattern for Crohn's Disease Patients Following Surgery

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