NCT01076426

Brief Summary

The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 26, 2010

Status Verified

February 1, 2010

Enrollment Period

28 days

First QC Date

February 24, 2010

Last Update Submit

February 25, 2010

Conditions

PeritonitisMalnutrition

Keywords

probioticperitoneal dialysisperitonitisnutrition status

Outcome Measures

Primary Outcomes (2)

  • peritonitis rate

    one year

  • nutrition status

    3, 6, 9, 12 months

Study Arms (2)

Probiotics

EXPERIMENTAL

probiotics treatment

Drug: Pro-biotics

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Oligosaccharide

Interventions

Pro-bioticsDRUG

Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.

Probiotics
OligosaccharideDIETARY_SUPPLEMENT

oligosaccharide one pack per day

Placebo

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. uremia patient under chronic peritoneal dialysis ≧ 3 months
  • \. Age between 16 and 75 years

You may not qualify if:

  • \. uremia patient with advanced malignance disease
  • \. uremia patient had more than 2 episode of G(+) peritonitis within the last one year
  • \. uremia patient with expected life ≦ 1 years
  • \. uremia patient with the history of drug or alcohol abuse
  • \. uremia patient with poor drug compliance
  • \. uremia patient with active infection disease
  • \. uremia patient with uncontrolled autoimmune disease such as SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

PeritonitisMalnutrition

Interventions

Oligosaccharides

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Officials

  • An-Bang WU, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

An-Bang Wu, MD

CONTACT

886-6-2353535anbang@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 26, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

February 26, 2010

Record last verified: 2010-02

Locations

TW(1)