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:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05439135
Eligibility Criteria:
Inclusion Criteria:
* Patients undergone nonphysiological reconstruction of the gastrointestinal tract (such as Billroth-II, Roux-en-Y, Child, Whipple reconstruction)
* Aged over 18 years old;
* Malnutrition is assessed by Nutritional Risk Screening 2002 score≥3 and Patient Generated Subjective Global Assessment (PG-SGA) score≥4;
* Written informed consent;
Exclusion Criteria:
* Expected survival time \< 3 months;
* Still on anti-tumor therapy or it is expected during the visit;
* Complicated with ascites or edema caused by malnutrition;
* Known organic gastrointestinal disease (e.g., gastrointestinal infection, inflammatory bowel disease, or radiation enteritis);
* Undergone other gastrointestinal surgery (e.g., enterectomy, enterostomy, or gastrostomy) except appendectomy or anal fistula surgery;
* Complicated with contraindications of enteral nutrition such as ileus, active gastrointestinal bleeding, and shock;
* Cannot tolerate gastroscopy or colonoscopy;
* Severe comorbidities (e.g., diabetes, cardiopulmonary failure, severe liver or or kidney diseases);
* Complicated with other wasting diseases (e.g., active tuberculosis, hyperthyroidism, diabetes, HIV, active hepatitis, hip fracture, craniocerebral injury, etc.);
* A history of anti-infective treatment within 30 days before enrollment; or need anti-infective treatment at the time of enrollment; or unwilling to stop taking drugs that affect gut microbes, such as probiotics;
* Can not tolerate oral enteral nutrition;
* Women who are pregnant or breastfeeding;
* Participating in another clinical trial;
* Deemed unsuitable for inclusion by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05439135
Study Brief:
Protocol Section:
NCT05439135