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

NCT04915911 | Unknown

• 1 other identifier: 2020-1109
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Appendicular skeletal mass index

  Bioelectrical impedance analysis

  Within 48 hours of admission to hospital

Secondary Outcomes (4)

• Body composition

  Within 48 hours of admission to hospital

• Nutritional risk screening

  Within 48 hours of admission to hospital

• Nutritional assessment

  Within 48 hours of admission to hospital

• Grip strength

  Within 48 hours of admission to hospital

Study Arms (1)

adult patients with Crohn's disease

multi-center cross-sectional study

Other: cross-sectional study

Interventions

cross-sectional study OTHER

cross-sectional study

adult patients with Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adult patients with Crohn's Disease

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pianhong Zhang, MS

CONTACT

+86 8778 3852; zrlcyyzx@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: June 7, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 15, 2021

Record last verified: 2021-04

Locations

CN (1)