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Effect of synbiotics on uremic toxins in hemodialysis patients

Effect of synbiotics on uremic toxins in hemodialysis patients - before-after study -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230290
Enrollment
40
Registered
2023-08-14
Start date
2023-08-14
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic Kidney Disease stage 5D Chronic Kidney Disease

Interventions

The treatment intervention period is 8 weeks, and you will take synbiotics (synprotec) twice a day (morning and after dinner).
Synbiotics (LBG-P)

Sponsors

Goda Tomohito
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Maintenance hemodialysis patients who are outpatients at the time of informed consent 2) Patients who introduced hemodialysis more than 6 months after consent was obtained 3) Patients who can self-medicate 4) Patients who are 18 years of age or older, have the ability to consent, and are able to obtain written consent of their own free will.

Exclusion criteria

Exclusion criteria: 1) Patients with dementia 2) Patients with inflammatory bowel disease, history of lower gastrointestinal surgery, marked ascites due to liver disease, active malignant tumor 3) Patients who cannot stop taking other probiotics and synbiotic preparations, including supplements, from 2 weeks before the start of study drug administration until the end of the study 4) Patients who cannot stop taking Lubiprostone, Linaclotide, and Elobixibat and general antiflatulent drugs from 2 weeks before the start of study drug administration until the end of the study 5) Patients taking many sleeping pills 6) Patients who are allergic to potatoes, corn, Lactobacillus/Bifidobacterium beverages/foods, and dairy products 7) Women who are pregnant, may become pregnant, or are breastfeeding 8) Patients with other conditions that the investigators judge to be inappropriate for the study

Design outcomes

Primary

MeasureTime frame
Changes in blood indoxyl sulfate level

Secondary

MeasureTime frame
1) blood p-cresyl sulfate level, phenyl sulfate level, trimethylamine-N-oxide concentrations 2) blood D amino acids concentrations 3) organic acids concentrations in stool, pH in stool 4) fecal indole level, indole lactate level, p-cresol level, phenol level, and trimethylamine concentrations 5) blood inflammation marker level 6) general blood tests (blood count, total protein, albumin, urea nitrogen, Cre, Na, K, Cl, Ca, P, uric acid) 7) other blood tests (neutral fat, total cholesterol, LDL cholesterol, HDL cholesterol) 8) change in quality of life:SF-36 (MOS Short-Form 36-Item Health Survey) version2 Japanese version 9) fecal condition:Bristol Scale 10) changes in sleep quality:Pittsburgh Sleep Quality Index 11) predialysis blood pressure

Contacts

Public ContactKenta Shimozawa

Juntendo University Hospital

k-shimozawa@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026