Nutritional Status and Body Composition of Adult Patients With Crohn's Disease

• Conditions: Crohn Disease
• Interventions: Other: cross-sectional study

• Registration Number: NCT04915911
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.

Detailed Description

Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Study Start: 2021-07-01
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years old;
• diagnosis of CD;
• Admission time <48 hours;
• Subject has voluntarily signed and dated an informed consent form.

Exclusion Criteria

• Emergency surgery for intestinal fistula or abdominal abscess;
• Unstable vital signs or unstable hemodynamics;
• Pregnant or lactating women;
• Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment);
• Dying patients whose life expectancy does not exceed 24 hours;
• Severe liver insufficiency (liver function score 11-15 or total bilirubin> 3mg/dL or tissue biopsy diagnosed as liver cirrhosis, hepatic encephalopathy, portal hypertension with history of gastrointestinal hemorrhage, etc.);
• Severe renal insufficiency (creatinine value is 2 times higher than the upper limit of normal);
• Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, etc.);
• Patients whose burn area exceeds 20% of the body surface area;
• Immunodeficiency, autoimmune disease, or receiving immunosuppressive treatment for diseases other than CD (such as organ transplantation, etc.);
• Those who are not suitable for body composition analysis
• Patients who have been selected for other clinical studies or have been selected for this study;
• Subjects are unwilling to participate in this study or refuse to sign informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients with Crohn's disease	cross-sectional study	multi-center cross-sectional study

Primary Outcome Measures

Name	Time	Method
Appendicular skeletal mass index	Within 48 hours of admission to hospital	Bioelectrical impedance analysis

Secondary Outcome Measures

Name	Time	Method
Body composition	Within 48 hours of admission to hospital	Especially body fat mass by bioelectrical impedance analysis
Nutritional risk screening	Within 48 hours of admission to hospital	Detect the presence of undernutrition and the risk of developing undernutrition by Risk Screening 2002 (NRS-2002), when score≥3, the patient is nutritionally at-risk
Nutritional assessment	Within 48 hours of admission to hospital	Detect malnourished individuals by the Subjective Global Assessment (SGA) , where A is well nourished and C is severely malnourished
Grip strength	Within 48 hours of admission to hospital	Hand grip strength test

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China