NCT00367588

Brief Summary

The purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

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

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2006

Completed
Last Updated

October 25, 2016

Status Verified

June 1, 2004

First QC Date

August 22, 2006

Last Update Submit

October 24, 2016

Conditions

Cytopenia

Keywords

chemotherapydiethematological malignancyinfection preventionprotective isolationPatients with cytopenia due to intensive chemotherapy for hematological malignancy

Outcome Measures

Primary Outcomes (1)

  • Colonization of the gut by aerobic Gram negative rods and yeasts

Secondary Outcomes (2)

  • The occurrence of infections

  • The total societal costs

Interventions

Low bacterial dietBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • acute leukemia receiving remission induction chemotherapy
  • receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood)
  • informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

CytopeniaHematologic Neoplasms

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Frank H. van Tiel, MD, PhD

    University Hospital Maastricht, Maastricht, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 23, 2006

Study Completion

June 1, 2004

Last Updated

October 25, 2016

Record last verified: 2004-06

Locations

NL(1)