Effect of EDIP Based Diet on CD Activity

NCT04736368 | Unknown DMC

• 1 other identifier: EDIPstudy
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease

Keywords

Crohn's Disease; EDIP diet; Therapy; Cerebrovascular Function

Outcome Measures

Primary Outcomes (1)

• Chron's Disease Activity Index

  The participants disease activity will be assessed with CDAI index.

  14 weeks post enrollment.

Secondary Outcomes (2)

• Mucosal Changes

  14 weeks post enrollment.

• Cerebrovascular Function

  14 weeks post enrollment.

Study Arms (2)

EDIP Group

EXPERIMENTAL

CD participants will receive EDIP diet information

Other: EDIP Diet Suggestions

Control Group

PLACEBO COMPARATOR

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

Other: diet guidance

Interventions

EDIP Diet Suggestions OTHER

CD participants will receive EDIP diet suggestions after random allocation.

EDIP Group

diet guidance OTHER

Control group will be given diet guidance according to routine experience under the participant's request.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 3, 2021
• Study Start: January 26, 2021
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01