What side effects are associated with this type of intervention?

Common treatments for kidney complications, especially in the context of renal transplants, include immunosuppressive drugs, antibiotics, and therapies that modulate gut microbiota like prebiotics and probiotics. Immunosuppressive drugs can cause side effects such as increased risk of infections, hypertension, and gastrointestinal issues. Antibiotics may lead to antibiotic resistance and gastrointestinal disturbances. Prebiotics and probiotics, similar to Human Milk Oligosaccharide (HMO) Prebiotic, are generally well-tolerated but can sometimes cause mild gastrointestinal symptoms like bloating, gas, and diarrhea. Rarely, they may lead to infections in immunocompromised patients.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney complications, particularly in the context of renal transplants. These include immunosuppressive drugs like mycophenolate mofetil (MMF) and biologics such as infliximab, which help reduce immune response and inflammation. While specific prebiotics like Human Milk Oligosaccharide (HMO) have not been widely approved for this purpose, the concept of modulating gut microbiota to improve immune function and reduce inflammation is gaining interest. Current treatments primarily focus on immunosuppression to prevent graft rejection and manage inflammation.

What other types of research exist?

Promising alternatives to HMO prebiotics for kidney complication patients include: 1) Probiotics such as Lactobacillus rhamnosus and Bifidobacterium breve, which have shown efficacy in modulating gut microbiota and reducing inflammation. 2) Synbiotics, which combine probiotics and prebiotics, have demonstrated benefits in reducing immune-related complications. 3) Modified bacterial products like heat-killed Escherichia coli (HKE) used as adjuvants in immunotherapy, which have shown potential in enhancing immune responses and reducing adverse reactions.

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Prebiotic

Prebiotic Therapy for Kidney Transplant Outcomes

Q: What is the mechanism of action of this treatment?

Common treatments for kidney complications often target the gut microbiota to improve immune function and reduce inflammation. Human Milk Oligosaccharide (HMO) prebiotics, for example, modulate the gut microbiota, promoting the growth of beneficial bacteria that enhance immune responses and decrease inflammatory processes. This is crucial for kidney complication patients as improved gut health can lead to better overall immune function and reduced systemic inflammation, potentially improving outcomes in conditions like renal transplants. Similarly, probiotics and synbiotics work by introducing beneficial microorganisms and prebiotics to the gut, which can help in reducing oxidative stress and inflammatory markers, thereby supporting kidney function and mitigating complications.

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

Must not have

History of carcinomas during the last 5 years

History of Crohn's disease and other related conditions.

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

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.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer within the last 5 years.

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

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I have had surgery on my intestines before.

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I am unable to understand and give consent for treatment.

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I am under 18 years old.

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I use probiotics or prebiotics.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Short Form Health Survey (SF-36)

Secondary study objectives

Therapeutic procedure

Microbiome changes post intervention

Other study objectives

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney complications often target the gut microbiota to improve immune function and reduce inflammation. Human Milk Oligosaccharide (HMO) prebiotics, for example, modulate the gut microbiota, promoting the growth of beneficial bacteria that enhance immune responses and decrease inflammatory processes. This is crucial for kidney complication patients as improved gut health can lead to better overall immune function and reduced systemic inflammation, potentially improving outcomes in conditions like renal transplants. Similarly, probiotics and synbiotics work by introducing beneficial microorganisms and prebiotics to the gut, which can help in reducing oxidative stress and inflammatory markers, thereby supporting kidney function and mitigating complications.

Effect of probiotics on oxidative stress and inflammatory status in diabetic nephropathy: A systematic review and meta-analysis of clinical trials.Alteration of the gut microbiota by vinegar is associated with amelioration of hyperoxaluria-induced kidney injury.