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The effects of gut microflora on protein-bound uremic toxins based on a peritoneal dialysis cohort: a protocol of placebo-controlled, double-blinded randomized cross-over trail

The effects of gut microflora on protein-bound uremic toxins based on a peritoneal dialysis cohort: a protocol of placebo-controlled, double-blinded randomized cross-over trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013739
Enrollment
Unknown
Registered
2017-12-06
Start date
2018-01-02
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Chronic Kidney Disease

Interventions

intervention group A:receive Oligofructose-enriched inulin
intervention group B:receive maltodextrin

Sponsors

TongJi Medical College Of Huazhong University Of Science & Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: patients with an estimated glomerular filtration rate (eGFR) lower than 15 ml/min/1.73 m2, receiving CAPD treatment longer than 3 months, aged between 18 and 65 years and able to provide informed consent.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they meet any of the following criteria: with a diagnosis of diabetes mellitus; consumed antibiotic therapy within 1 month of study commencement; receiving/or have received radiation to the bowel or large bowel resection; medically diagnosed irritable bowel syndrome, Crohns disease or ulcerative colitis; severely malnourished (Subjective Global Assessment > 15); having had a clinically significant change to their immunosuppressant dose within 6 months (determined by the medical team).

Design outcomes

Primary

MeasureTime frame
Indoxyl sulfate in serum, dialysate, urine and fecal samples;

Secondary

MeasureTime frame
p-cresyl sulfate n serum, dialysate, urine and fecal samples;estimate glomerular filtration rate,proteinuria, albuminuria and ß-2 microglobulin in 24-h urine ;microbiological analysis in stool samples;weekly total urea clearance (Kt/V) and weekly total creatinine clearance (Ccr);dietary protein and fiber intake;Serum albumin, prealbumin,the subjective global assessment score;serum including hs-CRP, interleukin6 (IL-6) and tumor necrosis factor-a (TNF-a);blood pressure, total cholesterol (TC), total triacylglycerol (TG), Low density lipoprotein (LDL), High density lipoprotein (HDL) and short chain fatty acids (SCFA) and serum carboxy methyl lysine;

Countries

China

Contacts

Public ContactXuezhi Zuo

Tongji Hospital, Tongji Medical College, Huazhong University Science and Technology

13886010354@163.com+86 13886010354

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026