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Effect of EDIP Based Diet on CD Activity

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EDIP Diet Suggestions
diet guidance
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with a confirmed diagnosis of CD were actively included for different treatment strategies.

Exclusion Criteria:

  • Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    EDIP Group

    Control Group

    Arm Description

    CD participants will receive EDIP diet information

    CD participants will be given diet suggestions according to routine experience.

    Outcomes

    Primary Outcome Measures

    Chron's Disease Activity Index
    The participants disease activity will be assessed with CDAI index.

    Secondary Outcome Measures

    Mucosal Changes
    The status and degree of mucosal healing will be assessed by colonoscopy.
    Cerebrovascular Function
    Near infrared spectroscopy will be used to assess cerebrovascular function.

    Full Information

    First Posted
    January 31, 2021
    Last Updated
    February 2, 2021
    Sponsor
    First Affiliated Hospital of Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04736368
    Brief Title
    Effect of EDIP Based Diet on CD Activity
    Official Title
    Empirical Dietary Inflammatory Pattern (EDIP) Based Dietary Suggestion on Disease Activity and Cerebrovascular Function in Crohn's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 26, 2021 (Anticipated)
    Primary Completion Date
    May 31, 2021 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital of Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Crohn's disease is a chronic recurrent systemic inflammatory disease. Studies have shown that meat, dairy products, fiber and vitamin D may affect the risk of Crohn's disease. The relationship between other dietary components and disease activity or recurrence in Chron's disease has not been fully studied. Although the patient's diet will affect the degree of disease activity, there is still no recognized daily diet model for CD patients. At present, the change of intestinal microbiome is considered to be one of the causes of IBD, and this change provides a theoretical basis for diet to reduce the inflammatory response in CD patients through the regulation of microbiome. Food driven inflammation may affect the activity of the disease. Brain-gut axis interaction may play an important role in CD and may have an effect on the cerebrovascular system. The investigators aim to evaluate the effects of Empirical Dietary Inflammatory Pattern (EDIP) based dietary suggestions on disease activity and cerebrovascular function as well as changes of intestinal flora and its metabolites amongst Chron's disease participants of all ages.
    Detailed Description
    Crohn's disease (CD) is a chronic recurrent systemic inflammatory disease, mainly affecting the gastrointestinal tract, accompanied by extra-intestinal complications and immune dysfunction. The relationship between other dietary components and disease activity or recurrence has not been fully studied and there is still no recognized daily diet model for CD. At present, the change of intestinal microbiome is considered to be one of the causes of Irritable Bowel Disease (IBD), and this change provides a theoretical basis for diet to reduce the inflammatory response those with CD through the regulation of microbiome. In inflammatory diseases, the potential inflammation of food may affect the activity of the disease. Empirical Dietary Inflammatory Pattern (EDIP) is a dietary inflammation index based on food group. 18 food groups were selected to evaluate the levels of inflammatory factors in human body which have already been verified by two independent female and male cohorts. The construction and validation of the scoring model revealed a strong correlation between EDIP and three plasma inflammatory markers: IL-6, CRP and TNFaR2, as well as other markers, such as adiponectin and the overall inflammatory marker score. Therefore, EDIP can be derived in a standardized way in different populations and be used to examine association with diseases whose pathogenesis is mainly attributed to chronic inflammation. Dietary inflammation index (DII) is a previously developed inflammation index based on nutrients. Compared to DII, dietary patterns based on food groups, such as EDIP, are more valuable for the establishment of dietary guidelines for health promotion and disease prevention. In addition, the brain-gut axis is the kink between the central nervous system and intestinal function but has not been extensively studied. In view of the fact that autoimmune diseases, and brain-gut axis interaction may play an important role in CD, we speculate that cerebrovascular function may also change during the occurrence and development of CD, especially during the EDIP score-based diet. The investigators plan to carry out a randomized controlled trial to systematically study the effects of EDIP score-based dietary suggestions on disease activity and cerebrovascular function of CD patients, as well as the changes of intestinal flora and its metabolites. The primary aim of this study is to systematically study the effects of EDIP based dietary recommendations on disease activity and cerebrovascular function of CD patients and establish a diet model suitable for CD patients. The secondary aims are to explore the possible changes of intestinal flora and its metabolites, and evaluate the changes of cerebrovascular function and the possible mechanism of their actions on CD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease
    Keywords
    Crohn's Disease, EDIP diet, Therapy, Cerebrovascular Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study design was a single-blinded randomized, parallel assignment clinical trial of CD participants was conducted. Participants were randomized in a 1:1 fashion to either 14-weeks of an EDIP based diet or a normal diet .
    Masking
    Participant
    Masking Description
    The study design was a single-blinded randomized, parallel assignment clinical trial of The study design was single blind and the participants did not know what diet intervention is being given to them.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EDIP Group
    Arm Type
    Experimental
    Arm Description
    CD participants will receive EDIP diet information
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    CD participants will be given diet suggestions according to routine experience.
    Intervention Type
    Other
    Intervention Name(s)
    EDIP Diet Suggestions
    Intervention Description
    CD participants will receive EDIP diet suggestions after random allocation.
    Intervention Type
    Other
    Intervention Name(s)
    diet guidance
    Intervention Description
    Control group will be given diet guidance according to routine experience under the participant's request.
    Primary Outcome Measure Information:
    Title
    Chron's Disease Activity Index
    Description
    The participants disease activity will be assessed with CDAI index.
    Time Frame
    14 weeks post enrollment.
    Secondary Outcome Measure Information:
    Title
    Mucosal Changes
    Description
    The status and degree of mucosal healing will be assessed by colonoscopy.
    Time Frame
    14 weeks post enrollment.
    Title
    Cerebrovascular Function
    Description
    Near infrared spectroscopy will be used to assess cerebrovascular function.
    Time Frame
    14 weeks post enrollment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with a confirmed diagnosis of CD were actively included for different treatment strategies. Exclusion Criteria: Participants with multi-system organ failure and/or other severe diseases not suitable for CD treatment intervention were further excluded.

    12. IPD Sharing Statement

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    Effect of EDIP Based Diet on CD Activity

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