Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease

NCT06342011 | Recruiting

• 1 other identifier: KY-2024-039
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.

Conditions

Inflammatory Bowel Diseases

Keywords

Anti-inflammatory diet; Inflammatory index; Quality of life

Outcome Measures

Primary Outcomes (3)

• C-reactive protein

  C-reactive protein (mg/L) is a non-specific inflammatory marker. It is an acute phase reaction protein synthesized by the liver to protect the body when pathogenic microorganisms invade the body.

  8 weeks after intervention

• Erythrocyte sedimentation rate (ESR)

  Erythrocyte sedimentation rate (mm/h) refers to the rate of erythrocyte sedimentation under certain conditions. The anticoagulant blood is placed in a vertically erected small glass tube. Due to the large proportion of red blood cells, it is naturally sunk by gravity. Under normal circumstances, the subsidence is very slow. The rate of erythrocyte sedimentation is often expressed by the distance of red blood cells sinking at the end of the first hour, called ESR.

  8 weeks after intervention

• Leukocyte

  White blood cells are colorless, spherical, nucleated blood cells. The total number of normal adults is (4.0 \~ 10.0)x 109/L, which can change in a certain range depending on the time of day and the functional state of the body.

  8 weeks after intervention

Secondary Outcomes (5)

• Self-Rating Anxiety Scale，SAS

  8 weeks after intervention

• Self-Rating depression scale，SDS

  8 weeks after intervention

• Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ)

  8 weeks after intervention

• Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES)

  8 weeks after intervention

• Body Mass Index

  8 weeks after intervention

Study Arms (2)

Regular diet group

NO INTERVENTION

Explain disease related knowledge; According to the patient's situation, give personalized dietary guidance, establish regular eating habits, carefully evaluate the types of food in the food, and avoid spicy stimulation, gas production, high fat and other foods that are easy to cause intestinal discomfort. SMS follow-up was conducted 3 days after discharge, and weekly phone follow-up was conducted to see if patients needed to solve problems and help them solve them in time.

Anti-inflammatory diet group

EXPERIMENTAL

AID knowledge education was given to patients in the intervention group after admission. At the same time, patients are asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by researchers, and teach patients how to use it, including the choice of anti-inflammatory diet, inappropriate anti-inflammatory diet, diet alarm clock, diet notes and other related functions. Missionary patients persisted with AID until re-examination 8 weeks later. The researchers conducted weekly telephone follow-up to urge the patients to adhere to the AID diet, answer the questions raised by the patients during the implementation process, and understand the patients' knowledge acceptance and diet implementation. Follow-up is carried out by qualified members of the training research team. Follow-up can take the form of face-to-face visit to the community or direct telephone follow-up, and make follow-up records.

Behavioral: Anti-inflammatory diet group

Interventions

Anti-inflammatory diet group BEHAVIORAL

Patients in the intervention group were given AID knowledge education, and patients were asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by the researchers to teach patients how to use it, including the selection of anti-inflammatory diet, unsuitable anti-inflammatory diet, diet alarm clock, diet notes and other related functions. The missionary patients insisted on AID until reexamination 8 weeks later.

Anti-inflammatory diet group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;
• The patient has clear consciousness and certain understanding, language expression and writing ability;
• Patients participated in this study knowingly and voluntarily;
• At least 18 years old.

You may not qualify if:

• cognitive impairment, mental illness, accompanied by mental disorders;
• Alcohol and drug abusers.
• The patient could not participate in the researcher due to the deterioration of the condition;
• Patients who voluntarily quit due to other reasons;
• Those who did not complete the assessment scale during the experiment.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xia Qian, BA

  The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Qian, BA

CONTACT

15968110117; 1632936247@qq.com

Lili Yang, PhD

CONTACT

13958131637; 3200006@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)