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Effects of oral nephrotic nutritional supplements on the production of uremic toxin and intestinal microenvironment in maintenance peritoneal dialysis patients with protein-energy wasting

Effects of oral nephrotic nutritional supplements on the production of uremic toxin and intestinal microenvironment in maintenance peritoneal dialysis patients with protein-energy wasting

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065704
Enrollment
Unknown
Registered
2022-11-13
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group:Oral nephrotic nutritional supplements

Sponsors

Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and<80 years; 2. Maintenance peritoneal dialysis, stable dialysis for more than three months; 3. Meet the PEW standard before enrollment, according to the PEW standard formulated by the expert group of the International Society for Renal Nutrition and Metabolism (IS-RNM) in 2008 : (1) Serum biochemical indicators: serum albumin<38g/L; Serum prealbumin level<0.3g/L; Serum total cholesterol level<1g/L; (2) Body mass index: body mass index (BMI)<23kg/m^2; The weight loss in 3 months was more than 5%, or in 6 months was more than 10%, and the total body fat content was less than 10% (bioelectrical impedance analysis (BIA) was used to measure body fat); At least one of the two criteria is met. 4. The study object understood and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. After gastrointestinal resection; 2. Patients with acquired immunodeficiency syndrome or with acquired immunodeficiency virus infection; 3. Previous malignant tumor history; 4. Serious cardiovascular and cerebrovascular diseases (such as stroke and myocardial infarction); 5. Serious autoimmune diseases; 6. Have participated in or are participating in other clinical studies within three months; 7. Pregnant or lactating patients; 8. Type 1 diabetes or type 2 diabetes with HbA1c>9%; 9. Severe edema; 10. Acute gastrointestinal diseases occurred within 2 weeks before enrollment; 11. Take any oral nutritional supplements (whether or not for peritoneal dialysis patients) within 4 weeks before inclusion; 12. Allergies to any component of oral nutritional supplements; 13. Within 2 weeks before enrollment, he took orally any nutrition or health care products for the purpose of improving intestinal flora, antibiotics for any reason and other drugs that may interfere with the composition of intestinal flora; 14. Chronic diarrhea; 15. The efficiency of peritoneal dialysis is poor, Kt/v < 1.2.

Design outcomes

Primary

MeasureTime frame
Uremic toxin;

Secondary

MeasureTime frame
Intestinal microenvironment;

Countries

China

Contacts

Public ContactRong Shu

Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

goldenxc@126.com+86 13681811669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026