End stage renal disease
Conditions
Interventions
MFGM-enriched oral nutritional supplements group:Oral nutritional supplement enriched with milk fat globular membrane protein was given once daily between meals and dietary guidance was given.
Standard oral nutritional supplement group:Oral nutritional supplements with the same macronutrient ratio and energy as MFGM group were given once a day between meals, and dietary guidance was given.
Control group:Dietary guidance is given by a professional dietitian according to the guidelines.
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years old, BMI<25 kg/m2. 2. Maintenance peritoneal dialysis, stable dialysis for more than three months; 3. Serum albumin < 38 g/L 4. Capable of taking in oral food; 5. The study object understood and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe heart, liver, and lung diseases, autoimmune diseases, active malignant tumors, severe gastrointestinal diseases, and a history of gastrointestinal surgery; 2. Serious infections such as peritonitis, endocarditis, soft tissue infections, pneumonia, etc. occurred within the past 1 months; 3. Patients who use oral energy supplements, antibiotics, micro-ecological modulators, gastrointestinal motility drugs and other agents affecting the intestinal flora within the past 1 months; 4. Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c > 9%; 5. Use of amino acid dialysate; 6. The efficiency of peritoneal dialysis is poor, Kt/v < 1.4; 7. Patients who have participated in other research projects in the past 3 months. 8. Pregnant or lactating women; 9. Allergies to any component of oral nutritional supplements; 10. Subject is considered unsuitable for the study based on the study physician's assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Albumin;Intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| MIS;Prealbumin;TP;Serum transferrin;hs-CRP;Inflammatory cytokines;Expression level of T lymphocyte subsets in peripheral blood;Serum immunoglobulin levels;KDQOL-36;Body composition analysis;Adequacy of dialysis; | — |
Countries
China
Contacts
Public ContactLi Juan
Shanghai Changzheng Hospital
Outcome results
None listed