Crohn's disease
Conditions
Interventions
Nutritional supplementation with Modulen, standard formula enriched with transforming growth factor beta. Case series of thirty patients with Crohns Disease or Ulcerative Colitis. Patients will be sup
G07.203.300.456
Sponsors
Faculdade de Medicina de Botucatu
Faculdade de Medicina de Botucatu
Universidade Federal do Rio de Janeiro
GastroSaúde - Clínica de Endoscopia, Gastroenterologia e Coloproctologia
Universidade Federal do Piauí
Kaiser Clínica
Clínica CEDIG
Pontifícia Universidade Católica do Rio Grande do Sul
USP Campus de Ribeirão Preto
Universidade Federal de São Paulo
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactLigia Sassaki
Faculdade de Medicina de Botucatu - FMB - UNESP
Outcome results
None listed