Assessment of Nutritional Status of Patients With Crohn's Disease

NCT03871634 | Completed

• 1 other identifier: 122
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease and better health-related quality of life. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Available studies in the literature have assessed the nutritional status of patients with Crohn's disease. However, sample size of available studies is small and highly heterogeneous, and most patients are hospitalized with active disease. The aim of the present study is a thorough assessment of nutritional status of 250 patients either with active Crohn's disease or in remission of the disease using multiple widely available tools and methods, in order to assess their accuracy and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition, sarcopenia, sarcopenic obesity and cachexia as well as overweight and obesity. Finally, the effect of the nutritional status on the course of the disease will be investigated.

Conditions

Crohn's Disease; Malnutrition; Overweight and Obesity; Sarcopenia; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

• Prevalence of malnutrition phenotypes

  Prevalence of different malnutrition phenotypes (e.g. undernutrition, sarcopenia, sarcopenic obesity), in crohn disease patients either with active disease or in remission, by implementing a thorough nutritional assessment.

  Baseline

Secondary Outcomes (1)

• Validity test of available tools

  Baseline

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

250 adult patients with active Crohn's Disease or in remission phase

You may qualify if:

• Adults with Crohn's Disease either with active disease or in remission phase.

You may not qualify if:

• Hospitalized patients
• Patients with Crohn's disease \<6 months
• Patients with cancer
• Patients with heart insufficiency
• Patients with renal insufficiency
• Patients with short bowel syndrome (SBS)
• Patients with parenteral nutrition.

Sponsors & Collaborators

• Harokopio University: lead
• Evangelismos Hospital: collaborator
• Sotiria General Hospital: collaborator
• General Hospital of Nikaia "Saint Panteleimon": collaborator

Study Sites (1)

Harokopio University

Athens, Kallithea, 17671, Greece

Location

MeSH Terms

Conditions

Crohn Disease; Malnutrition; Overweight; Obesity; Sarcopenia

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Nutrition

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: December 18, 2018
• Primary Completion: December 31, 2020
• Study Completion: August 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

GR (1)