se of nutritional suplement in patients with Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Crohn's disease; Ulcerative colitis

• Registration Number: RBR-955md27
• Lead Sponsor: Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-19
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients diagnosed with Crohn's Disease or Ulcerative Colitis; diagnosis of Inflammatory Bowel Disease based on clinical, endoscopic, histological or imaging criteria; patients with evidence of clinical or endoscopic activity of the disease AND OR; patients at nutritional risk who fall into one of the following categories: loss of 5% of body weight within 30 days; AND OR 10% loss of body weight within 3 months; AND OR presence of body mass index less than or equal to 18.5 kg/m2

Exclusion Criteria

Patients with chronic illnesses such as: Human immunodeficiency virus, Diabetes Mellitus, malignant neoplasms, heart, liver and or renal failure, tuberculosis or disabling mental illnesses; patients with undetermined colitis; use of another nutritional supplement concomitant with Modulen

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical, nutritional and quality of life improvement of patients with Inflammatory Bowel Disease (IBD) using Modulen® nutritional supplement, evaluated through clinical scores, nutritional assessment and quality of life questionnaire.

Secondary Outcome Measures

Name	Time	Method
<br>Secondary outcomes are not expected