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Prebiotic

Prebiotic Therapy for Kidney Transplant Outcomes

Q: Are there negative side effects to consuming HMO?

There is some clinical data supporting the efficacy of Human Milk Oligosaccharide (HMO), and it has undergone multiple rounds of testing for safety, so it received a score of 3.

Q: How many people are involved in this experiment?

That is accurate. The information available on clinicaltrials.gov show that this study, which was first advertised on February 23rd, is currently looking for participants. They need a total of 60 patients from 1 location.

Q: Are there any open positions in this clinical trial for new patients?

Yes, this information is accurate. The trial was first posted on February 23rd, 2022 and was updated on April 5th, 2022.

Phase < 1

Recruiting

Led By Alp Sener, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and over receiving a kidney transplant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day 1, 7, 30, 60, 90, 120, 150 and 180

Awards & highlights

Study Summary

This trial is testing whether a prebiotic called human milk oligosaccharide (HMO) can improve kidney transplant outcomes by reducing delayed graft function and side effects from post transplant therapy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from HMO treatment are not specified but may include digestive discomfort given its nature as a prebiotic. The study aims to assess the safety profile of HMO relative to placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 1, 7, 30, 60, 90, 120, 150 and 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 1, 7, 30, 60, 90, 120, 150 and 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 1, 7, 30, 60, 90, 120, 150 and 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Short Form Health Survey (SF-36)

Secondary outcome measures

Therapeutic procedure

Microbiome changes post intervention

Other outcome measures

Cystatin-c levels

Dialysis episodes

Estimated glomerular filtration rate (eGFR)

+11 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Human Milk Oligosaccharide (HMO)Active Control1 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: PlaceboPlacebo Group1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,672 Total Patients Enrolled

The W. Garfield Weston FoundationUNKNOWN

2 Previous Clinical Trials

91 Total Patients Enrolled

St. Joseph's Health Care LondonOTHER

27 Previous Clinical Trials

2,438 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there negative side effects to consuming HMO?

"There is some clinical data supporting the efficacy of Human Milk Oligosaccharide (HMO), and it has undergone multiple rounds of testing for safety, so it received a score of 3."

Answered by AI

How many people are involved in this experiment?

"That is accurate. The information available on clinicaltrials.gov show that this study, which was first advertised on February 23rd, is currently looking for participants. They need a total of 60 patients from 1 location."

Answered by AI