NCT06883422 Pre-Surgical Immunonutrition's Effect on Colorectal Surgery
| NCT ID | NCT06883422 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Condition | Colorectal Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2023-05-25 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive. The objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.
Eligibility Criteria
Inclusion Criteria: * Both sexes * Over 18 years of age * Scheduled for elective colorectal surgery (Resection and intestinal reconnection) * Obtaining patient consent Exclusion Criteria: * Consumption of nutritional supplements during the 2 weeks prior to patient enrollment * Consumption of additional nutritional supplements during the 7 days corresponding to the study intervention period * Patients diagnosed with chronic kidney disease * Patients diagnosed with hepatic cirrhosis * Documented allergy to any of the ingredients in the formulas under evaluation (milk and/or soy).
Contact & Investigator
Aurora E Serralde Zúñiga, MD, PhD
PRINCIPAL INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Frequently Asked Questions
Who can join the NCT06883422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883422 currently recruiting?
Yes, NCT06883422 is actively recruiting participants. Contact the research team at aurozabeth@yahoo.com.mx for enrollment information.
Where is the NCT06883422 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06883422 clinical trial?
NCT06883422 is sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The principal investigator is Aurora E Serralde Zúñiga, MD, PhD at Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The trial plans to enroll 126 participants.