Transplant Trial Watch

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study.

Chan, S., et al.

Journal of Renal Nutrition 2022 [record in progress].


Aims
This study aimed to evalute the feasibility of conducting a randomised controlled trial on the effect of prebiotics in reducing the incidence of infections and gastrointestinal symptoms in kidney transplant patients.

Interventions
Participants were randomised to receive either prebiotics or placebo.

Participants
56 acute kidney transplant recipients.

Outcomes
The primary endpoint was feasibility. The secondary endpoints were adherence and tolerability, participant retention, gastrointestinal symptom and infection events, proportions of participants providing serum and stool specimens, and quality of life.

Follow-up
1.8 months (median)

CET Conclusions
The double-blind, randomised controlled trial evaluated the feasibility of taking prebiotics during 7 weeks in adult kidney transplant recipients and effect of prebiotics on gastrointestinal symptoms. Participants were randomised according to a randomisation schedule and allocation to prebiotics or a matching placebo was concealed. The primary outcome was feasibility, i.e. whether 60 participants could be recruited within 6 months and the proportion of eligible patients who agreed to participate in the study. Recruitment took slightly longer than 6 months and out of the 72 eligible patients, 56 participants were randomised (78%). The secondary outcome treatment adherence was similar between groups but lower than the targeted 80% (67% and 72% for the prebiotics and control groups, respectively. Tolerability, i.e. continuation of prebiotic supplementation was moderate but retention after randomisation was 100% in both groups. The prebiotics group reported less gastrointestinal symptoms than the control group.

Jadad score
5

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ACTRN12618001057279

Funding source
Non-industry funded