Prebiotics in Peritoneal Dialysis

Ali Ramezani

Status: Completed

Conditions: Gut Microbiome Dysbiosis; End Stage Renal Disease

Treatments: Dietary Supplement: P-inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03265639

091440

Details and patient eligibility

About

The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.

Enrollment: 9 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peritoneal dialysis therapy for end-stage renal disease
• ≥30 days since dialysis initiation
• Ability to provide informed consent

Exclusion criteria

• Use of pre- or pro-biotics during the past 2 months
• Consumption of pro-biotic yogurt during the past 2 weeks
• Use of antibiotics within the past 2 months
• Presence of chronic infection
• Chronic gastrointestinal condition other than constipation
• Cirrhosis or chronic active hepatitis
• Stomach/intestinal resection
• PD access problems
• Anticipated kidney transplant or transfer to another dialysis unit within 9 months
• Expected survival < 9 months
• Pregnancy, anticipated pregnancy, or breastfeeding
• Incarceration
• Participation in another intervention study
• Severe anemia defined as hemoglobin <9.0 g/dl

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Pre-treatment

No Intervention group

Description:

This arm is the 8-week observation period before the p-inulin treatment phase.

Intervention

Experimental group

Description:

This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).

Treatment:

Dietary Supplement: P-inulin

Post-treatment

No Intervention group

Description:

This arm is the 8-week observation period after the p-inulin treatment phase.