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Modulation of Gut Microbiota in End-stage Renal Disease (MGM-dialysis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02568891
Recruitment Status : Withdrawn (No funding obtained)
First Posted : October 6, 2015
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
In end-stage renal disease (ESRD) cardiovascular and infectious complications are common. The gut microbiome might play an important pathophysiological role. ESRD is hypothesized to be associated with profound alterations of gut microbiome and gut permeability. The investigators aim to test whether a multispecies probiotic mixture is able to revert the microbiome changes and decrease gut permeability. Furthermore the investigators aim to test whether this improvement in microbiome composition and gut permeability is also associated with improvements in endotoxemia, uremia and cardiovascular risk factors.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Modulation of Gut Microbiota in End-stage Renal Disease: A Pilot Study
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Probiotic
6 g of Winclove-849 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g
Dietary Supplement: Probiotic
multispecies probiotic

Placebo Comparator: Placebo
similar looking and tasting placebo without bacteria
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Gut microbiome [ Time Frame: 1 year ]
    changes in gut microbiome composition

Secondary Outcome Measures :
  1. gut permeability (zonulin in stool) [ Time Frame: 1 year ]
    changes in gut permeability

  2. bacterial translocation (bacterial DNA in serum) [ Time Frame: 1 year ]
    decrease in bacterial translocation

  3. neutrophil phagocytic capacity [ Time Frame: 1 year ]
    improvement in neutrophil function

  4. glucose metabolism (meal tolerance test) [ Time Frame: 1 year ]
    improvement in glucose metabolism

  5. uremia toxins [ Time Frame: 1 year ]
    decrease in uremia toxins

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Informed consent
  • Patients with end-stage renal disease [5] undergoing any modality of renal replacement therapy (hemodialysis, hemodiafiltration or peritoneal dialysis)

Exclusion Criteria:

  • Malignancy
  • Pregnancy
  • Chronic inflammatory bowel disease
  • Celiac disease
  • Active alcohol abuse (>40g alcohol per day)
  • Any severe organ dysfunction unrelated to renal dysfunction

    20 healthy family members (living in the same household) of patients will be recruited as controls

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02568891

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Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Vanessa Stadlbauer, MD Medical University of Graz
Principal Investigator: Harald Sourij, MD Medical University of Graz
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Responsible Party: Medical University of Graz Identifier: NCT02568891    
Other Study ID Numbers: 26-255 ex 13/14
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency