Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367588
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2006-08-22
Brief Title:
Low Bacterial Diet in Patients With Cytopenia
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy a Study of Efficacy
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None