Effect of synbiotics on uremic toxins in hemodialysis patients

JRCT ID: jRCTs031230290

Registered date:14/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease stage 5D
• Date of first enrollment: 14/08/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The treatment intervention period is 8 weeks, and you will take synbiotics (synprotec) twice a day (morning and after dinner).

Outcome(s)

• Primary Outcome: Changes in blood indoxyl sulfate level

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Goda Tomohito
• Source(s) of Monetary Support: Juntendo Advanced Research Institute for Health Science