Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT05609006
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years
* Patients who are in one of the following clinical situations: oncological patients who did not undergo surgery during the month prior to inclusion, including head and neck, esophagus, stomach, pancreas, or colon cancer; surgical patients who underwent surgery less than one month, including all types of surgical processes; and other non-surgical patients diagnosed with benign esophageal stricture, chronic radiation enteritis, and non-oncological maxillofacial pathology, cystic fibrosis, human immunodeficiency virus (HIV), malabsorption syndrome , ulcerative colitis, Crohn's disease, fistula, intestinal pseudo-obstruction, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), or who were undergone to scheduled major surgery or transplantation within a period of no less than 2 months until inclusion.
* Patients with malnutrition or at risk of malnutrition according to Subjective Global Assessment (SGA).
* Patients with a high energy requirement that require 2 bottles/day of an ONS (≥2kcal/ml), for a minimum period of 8 weeks
* Patients who have not received ONS during the month prior to their inclusion. Surgical patients may have received ONS prior to the study in accordance with the guidelines of the institution.
* Patients who voluntarily agree to participate in the study and give their signed consent for participation.
Exclusion Criteria:
* Patients suffering from any of the following clinical disorders: chronic kidney insufficiency or diabetes.
* Patients requiring enteral tube feeding or parenteral nutrition.
* Patients suffering from an allergy or intolerance to the product ingredients.
* Patients scheduled for surgery during the study period.
* Patients who, in the opinion of the treating physician, are unable to adhere to the protocol instructions, including inability of the patient/caregiver to use the study eCRF, and to remain in the study during all the follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05609006
Study Brief:
Protocol Section:
NCT05609006