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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: cross-sectional study

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Pianhong Zhang, MS; Phone Number: +86 8778 3852; Email: zrlcyyzx@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Pianhong Zhang, Ms; Phone Number: +86 87783852; Email: zrlcyyzx@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese adult patients with Crohn's Disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adult patients with Crohn's disease; multi-center cross-sectional study	Other: cross-sectional study; cross-sectional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular skeletal mass index	Bioelectrical impedance analysis	Within 48 hours of admission to hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Especially body fat mass by bioelectrical impedance analysis	Within 48 hours of admission to hospital
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
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
Grip strength	Hand grip strength test	Within 48 hours of admission to hospital

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2020-1109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No