Low Bacterial Diet in Patients With Cytopenia
Primary Purpose
Cytopenia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Low bacterial diet
Sponsored by
About this trial
This is an interventional prevention trial for Cytopenia focused on measuring chemotherapy, diet, hematological malignancy, infection prevention, protective isolation, Patients with cytopenia due to intensive chemotherapy for hematological malignancy
Eligibility Criteria
Inclusion Criteria: acute leukemia receiving remission induction chemotherapy receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood) informed consent Exclusion Criteria: none
Sites / Locations
- University Hospital Maastricht
Outcomes
Primary Outcome Measures
Colonization of the gut by aerobic Gram negative rods and yeasts
Secondary Outcome Measures
The occurrence of infections
The total societal costs
Full Information
NCT ID
NCT00367588
First Posted
August 22, 2006
Last Updated
October 24, 2016
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00367588
Brief Title
Low Bacterial Diet in Patients With Cytopenia
Official Title
Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2004
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
5. Study Description
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.
Detailed Description
Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. Mucositis can also develop in these patients, enabling micro-organisms, belonging to the endogenous intestinal flora, to translocate from the intestine to the lymphoid tissue and blood. Therefore, when mucositis and cytopenia develop simultaneously, the risk of infection increases further. In this regard bloodstream infection by Gram negative rods and yeasts are an important cause of serious infections causing considerable morbidity.
In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. These measures include protective (or reverse) isolation, antibiotic prophylaxis with antibiotics which selectively eradicate the aerobic Gram negative rods and yeasts from the gut flora, and finally the use of low-bacterial diets.
In this prospective, randomized study on the efficacy of low bacterial diet, in comparison to normal hospital diet, gut colonization by aerobic Gram negative rods and yeasts, the occurrence of infections and the total costs of hospital care were chosen as study endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytopenia
Keywords
chemotherapy, diet, hematological malignancy, infection prevention, protective isolation, Patients with cytopenia due to intensive chemotherapy for hematological malignancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Low bacterial diet
Primary Outcome Measure Information:
Title
Colonization of the gut by aerobic Gram negative rods and yeasts
Secondary Outcome Measure Information:
Title
The occurrence of infections
Title
The total societal costs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute leukemia receiving remission induction chemotherapy
receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood)
informed consent
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank H. van Tiel, MD, PhD
Organizational Affiliation
University Hospital Maastricht, Maastricht, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
12. IPD Sharing Statement
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Low Bacterial Diet in Patients With Cytopenia
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