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

Crohn Disease Clinical Trial

Official title:

A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915911
• Other study ID #: 2020-1109
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pianhong Zhang, MS
• Phone: +86 8778 3852
• Email: zrlcyyzx[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• cross-sectional study
cross-sectional study

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appendicular skeletal mass index	Bioelectrical impedance analysis	Within 48 hours of admission to hospital
Secondary	Body composition	Especially body fat mass by bioelectrical impedance analysis	Within 48 hours of admission to hospital
Secondary	Nutritional risk screening	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	Within 48 hours of admission to hospital
Secondary	Nutritional assessment	Detect malnourished individuals by the Subjective Global Assessment (SGA) , where A is well nourished and C is severely malnourished	Within 48 hours of admission to hospital
Secondary	Grip strength	Hand grip strength test	Within 48 hours of admission to hospital