Clinical trial NCT04915911: Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
Official title: A Multi-center, Cross-sectional Observational Study on Nutritional Status and Body Composition of Adult Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese adult patients with Crohn's Disease

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Appendicular skeletal mass index
timeFrame: Within 48 hours of admission to hospital
Secondary outcomes:
measure: Body composition
timeFrame: Within 48 hours of admission to hospital
measure: Nutritional risk screening
timeFrame: Within 48 hours of admission to hospital
measure: Nutritional assessment
timeFrame: Within 48 hours of admission to hospital
measure: Grip strength
timeFrame: Within 48 hours of admission to hospital
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: