Prebiotic Therapy for Kidney Transplant Outcomes

Overseen by Alp Sener, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

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

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.

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.

Treatment Details

Interventions

• Human Milk Oligosaccharides (HMO) (Prebiotic)
• Placebo (Other)

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+

Lisa Porter

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

Chief Medical Officer

PhD in Biomedical Sciences

Roy Butler

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

Chief Executive Officer

PhD in Health Sciences

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

Lead Sponsor

Trials

668

Recruited

424,000+

Roy Butler

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

Chief Executive Officer

PhD in Health Sciences

Dr. Cindy Hutnik

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

Chief Medical Officer

MD, PhD

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

Lead Sponsor

Trials

686

Recruited

427,000+

Dr. Alex Barron

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

Chief Medical Officer since 2023

MD from Western University

David Musyj

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

Chief Executive Officer

Physiotherapy degree

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Dr. Michael Strong

Lawson Health Research Institute

Chief Medical Officer

MD

Roy Butler

Lawson Health Research Institute

Chief Executive Officer

PhD in Health Sciences

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+

Dr. Alex Barron

London Health Sciences Centre

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre

Chief Executive Officer

Bachelor of Laws (LLB) from the University of Windsor