Last updated: September 20, 2023
Sponsor: Danone Specialized Nutrition
Overall Status: Active - Recruiting
Phase
4
Condition
Chronic Obstructive Pulmonary Disease (Copd)
Gastrointestinal Diseases And Disorders
Chronic Bronchitis
Treatment
Fortimel
Clinical Study ID
NCT06055543
Fortimel PlantBased Spain 2022
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients ≥ 18 years old
- Malnourished patients according to GLIM criteria
- Patients with a high energy requirement (1.5kcal/ml) requiring the intake of 2bottles of ONS per day for at least 12 weeks
- Patients presenting any of the following clinical situations:
- Elderly patients requiring oral nutritional support
- Patients with digestive pathology including but not restricted to inflammatory boweldisease, short bowel syndrome, pancreatitis, without active malabsorption andmaldigestion.
- Chronic diseases such as COPD, mild to moderate renal disease, HIV
- Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1
- Patients who have given their consent to participate
- Patients who, in the opinion of the physician, have the capacity to answer thestudy questionnaires themselves or their caregivers
Exclusion
Exclusion Criteria:
- Patients who need ONS due to surgical or acute illness*
- Patients with known intolerance or allergy to cow's milk, soya or peas
- Patients with hyperthyroidism. Patients with uncontrolled hypothyroidism
- Uncontrolled diabetic patients (HbA1c >8%)
- Patients requiring enteral nutrition by tube or ostomy
- Patients with moderate and serious renal insufficiency < 30ml/min/1,73 m2
- Patients who have value creatinine:
- 1,70 mg/dl - 150,31umol/L Men
- 1,50 mg/dl - 132,63umol/L Women
- Patients with levels of haemoglobin <10 g/dl, transferrin <150 mg /dl
Study Design
Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Fortimel
Phase: 4
Study Start date:
August 09, 2023
Estimated Completion Date:
May 31, 2024
Study Description
Connect with a study center
Hospital Universitario de Basurto
Bilbao, 48013
SpainActive - Recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
SpainActive - Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
SpainActive - Recruiting
Hospital Universitario de Móstoles
Madrid, 28935
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Clínico Valladolid
Valladolid, 47003
SpainActive - Recruiting
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