NCT02364869

Brief Summary

This 12-week double-blind randomized controlled clinical trial aims to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

January 13, 2015

Last Update Submit

April 6, 2017

Conditions

Chronic Kidney Disease

Keywords

P-cresyl sulfateIndoxyl sulfateIntestineEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate

    12 weeks

Secondary Outcomes (13)

  • Endotoxemia measured by serum levels of lipopolysaccharides

    12 weeks

  • Intestinal permeability evaluated by serum levels of Zonulin

    12 weeks

  • Intestinal epithelium evaluated by serum levels of glucagon-like peptide 2 (GLP2)

    12 weeks

  • Intestinal epithelium evaluated by serum levels of epidermal growth factor (EGF).

    12 weeks

  • Inflammation measured by serum levels of Interleukin-6 (IL-6)

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Fructooligosaccharide

EXPERIMENTAL

12g daily, for 12 weeks

Dietary Supplement: Fructooligosaccharide

Maltodextrin

PLACEBO COMPARATOR

12g daily, for 12 weeks

Dietary Supplement: Maltodextrin

Interventions

FructooligosaccharideDIETARY_SUPPLEMENT

Patients will be evaluated at baseline, week 6 and 12.

Also known as: Prebiotic
Fructooligosaccharide
MaltodextrinDIETARY_SUPPLEMENT

Placebo Comparator. Patients will be evaluated at baseline, week 6 and 12.

Maltodextrin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years
  • Estimated glomerular filtration rate between 45 to 15 ml/min/1,73m².

You may not qualify if:

  • diabetes mellitus, malignance, severe liver disease, autoimmune diseases, congestive heart failure class III / IV, HIV, history of gastrointestinal disease
  • use of phosphate binders, laxatives or prebiotic, probiotic, symbiotic, antibiotics, immunosuppressants and / or anti-inflammatory drugs three months preceding the study.
  • patients using laxatives who refuse to stop treatment during the follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

    PMID: 37870148DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

fructooligosaccharidePrebioticsmaltodextrin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Lilian Cupari, PhD

    Affiliate professor of Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 18, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

BR(1)