Modulation of Gut Microbiota in End-stage Renal Disease

NCT02568891 | Withdrawn

• 1 other identifier: 26-255 ex 13/14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  changes in gut microbiome composition

  1 year

Secondary Outcomes (5)

• gut permeability (zonulin in stool)

  1 year

• bacterial translocation (bacterial DNA in serum)

  1 year

• neutrophil phagocytic capacity

  1 year

• glucose metabolism (meal tolerance test)

  1 year

• uremia toxins

  1 year

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

similar looking and tasting placebo without bacteria

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

multispecies probiotic

Probiotic

Placebo DIETARY_SUPPLEMENT

matrix

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Malignancy
• Pregnancy
• Chronic inflammatory bowel disease
• Celiac disease
• Active alcohol abuse (\>40g alcohol per day)
• Any severe organ dysfunction unrelated to renal dysfunction
• healthy family members (living in the same household) of patients will be recruited as controls

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vanessa Stadlbauer, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Harald Sourij, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: October 6, 2015
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

AU (1)