NCT01391468

Brief Summary

This is a randomized double blinded placebo control studies are performed in Chronic Kidney Disease (CKD) patients. After informed consent, intervention group receives probiotics containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo group receives corn starch. In the first year the investigators examine the 60 peritoneal dialysis (PD) patients, in the second year the investigators do the 60 hemodialysis (HD) patients, and in the third year the investigators do the 60 stage 3 and 4 CKD patients. Primary endpoint is cardiovascular event, gastrointestinal symptoms, peritonitis in PD patients, and progression of stage 3 and 4 CKD. Values are compared between the groups by unpaired t test. X2 testis used to compare proportions between the groups. Relative risk and the number needed to treat, both with 95% CI, are used to describe the treatment effect of probiotics. A p value less than 0•05 is regarded as statistically significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Typical duration for phase_4

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

July 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 24, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

July 8, 2011

Results QC Date

February 2, 2015

Last Update Submit

October 9, 2015

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • the Occurrence of Cardiovascular Event and Peritonitis Events

    6 month follow-up

Secondary Outcomes (1)

  • Change of Gastrointestinal Symptoms at 6 Months

    6 months follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

cornstarch

Dietary Supplement: Cornstarch

Probiotics

EXPERIMENTAL

probiotics

Dietary Supplement: Probiotics

Interventions

ProbioticsDIETARY_SUPPLEMENT

intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations

Probiotics
CornstarchDIETARY_SUPPLEMENT

placebo will be given in 6 months

Placebo

Eligibility Criteria

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

You may qualify if:

  • receiving peritoneal dialysis for more than 3 months, at least 18 years of age, and GFR \< 15 ml/min.
  • receiving hemodialysis dialysis for more than 3 months, at least 18 years of age, and GFR \< 15 ml/min.
  • Stage 3 and 4 CKD patients

You may not qualify if:

  • active infectious conditions within the last 30 days,
  • pregnancy for female,
  • autoimmune disease e.g. SLE.,
  • cardiovascular events before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 413, Taiwan

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

ProbioticsStarch

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 SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Results Point of Contact

Title
II-Kuan Wang
Organization
China Medical University
ikwang@seed.net.tw
88975681050

Study Officials

  • I-Kuan Wang, M.D.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
China Medical University Hospital

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 12, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 3, 2015

Results First Posted

August 24, 2015

Record last verified: 2015-10

Locations

TW(1)