Prebiotic Therapy for Kidney Transplant Outcomes

Overseen By Jeremy P Burton, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Must not be taking: Probiotics, Prebiotics

Disqualifiers: Under 18, Carcinomas, Bowel surgery, Crohn's, others

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special sugar from human milk to help kidney transplant patients. It aims to improve their health by boosting good gut bacteria, which can reduce inflammation and help the kidney work better.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those using probiotics or other prebiotics.

What data supports the effectiveness of the treatment Human Milk Oligosaccharides (HMO) for kidney transplant outcomes?

Research on prebiotics, similar to HMOs, shows they can help improve gut health and reduce infections in kidney transplant patients by promoting beneficial bacteria. Additionally, studies on other prebiotics like resistant maltodextrin have shown benefits in managing gut health in chronic kidney disease, which may suggest potential benefits for kidney transplant recipients. ^{1 2 3 4 5}

Is prebiotic therapy safe for humans?

Prebiotic treatments, like those studied in kidney transplant recipients and patients with chronic kidney disease, have generally been found to be safe in humans, with no significant adverse effects reported in the studies. ^{1 2 3 6 7}

How is the prebiotic treatment for kidney transplant outcomes different from other treatments?

This prebiotic treatment is unique because it aims to improve kidney transplant outcomes by modulating the gut microbiome, which is a novel approach not previously explored in this context. Unlike traditional treatments that focus directly on the kidney or immune system, this therapy targets the large intestine to potentially reduce infections and gastrointestinal issues in transplant recipients. ^{1 2 3 4 6}

Research Team

Alp Sener, MD

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for adults over 18 who are receiving a kidney transplant. It's not suitable for those under 18, unable to consent, with recent carcinomas, using other prebiotics or probiotics, or with a history of bowel surgery and conditions like Crohn's disease.

Inclusion Criteria

I am 18 or older and am receiving a kidney transplant.

Exclusion Criteria

I have had cancer within the last 5 years.

I have a history of Crohn's disease or similar conditions.

I have had surgery on my intestines before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either HMO prebiotic or placebo for 12 weeks to test its effect on renal transplant outcomes

12 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of graft function and microbiome changes

12 weeks

6 visits (in-person or virtual)

Long-term follow-up

Participants continue to be monitored for adverse events and graft function

24 weeks

Treatment Details

Interventions

• Human Milk Oligosaccharides (HMO)
• Placebo

Trial Overview The study tests if Human Milk Oligosaccharides (HMO), a type of prebiotic, can improve kidney transplant outcomes compared to a placebo. Participants will be randomly assigned to receive either HMO or placebo in double-blind fashion for 12 weeks.

Participant Groups

Group I: Human Milk Oligosaccharide (HMO) Active Control 1 Intervention

10 g sachet, self-administered for 3 months. 2'-O-fucosyllactose and lacto-N-neotetraose, novel human milk oligosaccharide (HMO) sugars have been shown to stimulate the production of short chain fatty acids, especially propionate. Propionate has been shown to be important in attenuating hypertrophy, fibrosis, vascular dysfunction and hypertension (Bartolomaeus H et al 2019Mar12) and extremely important for the gut kidney axis (Li L et al 2017Dec11).

Group II: Placebo Placebo Group 1 Intervention

10 g sachet, self-administered for 3 months. Placebo sachets are identical to the HMO sachets in color, taste, smell, size and shape

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

The W. Garfield Weston Foundation

Collaborator

Trials

4

Recruited

210+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prebiotic Supplementation in Kidney Transplant Recipients for Preventing Infections and Gastrointestinal Upset: A Randomized Controlled Feasibility Study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

PREBIOTIC: a study protocol of a randomised controlled trial to assess prebiotic supplementation in kidney transplant recipients for preventing infections and gastrointestinal upset - a feasibility study. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Usefulness of Resistant Maltodextrin and Chitosan Oligosaccharide in Management of Gut Leakage and Microbiota in Chronic Kidney Disease. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Effects of Prebiotic Fiber Xylooligosaccharide in Adenine-Induced Nephropathy in Mice. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Probiotics, Prebiotics, and Synbiotics for Patients on Dialysis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Influence of Prebiotic Arabinoxylan Oligosaccharides on Microbiota Derived Uremic Retention Solutes in Patients with Chronic Kidney Disease: A Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of a Short-Course Treatment with Synbiotics on Plasma p-Cresol Concentration in Kidney Transplant Recipients. [2018]