Investigating the effect of synbiotics on uremic toxin concentrations in the pre-dialysis population.

Randomized, double-blind, placebo-controlled crossover study in the pre-dialysis population assessing the benefit of synbiotics on serum uremic toxin concentrations

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000493741

Acronym

SYNERGY

Enrollment

Registered

2013-05-02

Start date

2013-04-29

Completion date

2013-10-15

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The main objective of this study is to assess the effect of synbiotics (co-administration of both pre- and probiotics) as a potential treatment targeting damaging kidney toxins related to heart disease and kidney disease progression in advanced chronic kidney disease patients.

Interventions

This study will involve 4 stages: 1. Pre-study period (2 weeks) 2. Study period 1 (intervention 1) (6 weeks) 3. “Washout” period (4 weeks) 4. Study period 2 (intervention 2) (6 weeks) In the pre-study period patients will have measurements taken and discuss with the dietitian about healthy eating for kidney disease. During the study period 1 (intervention 1) the patient will be provided with either placebo powder and tablets (these are designed to have no physical effect) or prebiotic powder and probiotic tablets to take for six weeks. During intervention 2, patients will crossover to the other powder and tablets (ie: if they received placebo in the first six weeks, they will receive the prebiotic powder and probiotic tablets in the second six weeks and vice versa). Probiotic dose= 40billion CFU 2 x daily Prebiotic dose= 7.5g 2 x daily Adherence to the supplements will be monitored through a supplement count and weighing, and adherence to a stable diet will be monitored using 24hr food recalls

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

*CKD stage IV: GFR stable between 10-30 ml/min/1.73m2 (for the past 3 months) *Able to provide informed consent

Exclusion criteria

*Previous transplant or on immunosuppressants *Receiving/ or have received radiation to the bowel *Received prebiotic, probiotic or anti-biotic therapy within 1 month of study commencement *Non-English speaking *Unable/unwilling to comply with frequent follow-up *Active medically diagnosed Irritable Bowel Syndrome *Life expectancy limited due to pre-existing malignancy or other disease (<6 months) *Likely to progress to dialysis within 6 months as determined by the treating physician *Likely transplant recipient within 6 months *Pregnancy *Severely malnourished (Subjective Global Assessment: C)

Outcome results