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NOT YET RECRUITING
NCT07850375
NA

Nutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This is a multi-center observational study. The study aims to explore the effect of enteral nutritional support on nutritional status and clinical outcomes in patients after hematopoietic stem cell transplantation. Eligible participants will receive routine clinical care combined with nutritional intervention at each participating site. We will collect clinical and laboratory indicators to evaluate changes in nutrition-related indexes. No extra invasive procedures will be performed for research purposes.

Official title: Effect of Nutritional Intervention on Disease Outcomes in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-10-12

Completion Date

2030-10-30

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Enteral Nutritional Suspension (TP-MCT)

500 mL per day of enteral nutritional suspension (TP-MCT), whole-protein formula, 1 kcal/mL, administered orally in addition to routine dietary guidance. Dose titrated from 20-50 mL initial volume to target dose according to gastrointestinal tolerance. Provided by Nutricia Pharmaceutical (Wuxi) Co., Ltd.

BEHAVIORAL

Routine nutritional guidance

Standard clinical dietary guidance without oral nutritional supplement. Parenteral nutrition will be supplemented to meet target energy requirements when oral intake is insufficient.

OTHER

Biospecimen-Stool Sample Collection

Collection of 40 g first-voided fresh stool samples at seven predefined study time-points for gut microbiota analysis. Specimens are transported under 4 °C cold-chain conditions and stored long-term at -80 °C for laboratory testing.

OTHER

Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring

24-hour non-contact sleep-breathing monitoring is performed via millimeter-wave radar device on the day of conditioning initiation and on the day of stem-cell infusion. No wearable sensors are required for participants to collect sleep-respiratory parameters.

Locations (3)

The First Hospital of Jilin University

Changchun, Jilin, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China