Trial record 4 of 4 for:    "dyserythropoietic anemia and thrombocytopenia" [DISEASE] OR NCT00730314 [ID-NUMBER] OR NCT00004378 [ID-NUMBER] OR NCT00001620 [ID-NUMBER] OR NCT00367588 [ID-NUMBER]

Low Bacterial Diet in Patients With Cytopenia

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00367588
First received: August 22, 2006
Last updated: October 19, 2006
Last verified: June 2004
  Purpose

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.


Condition Intervention
Cytopenia
Behavioral: Low bacterial diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

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

Estimated Enrollment: 20
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367588

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University
Investigators
Principal Investigator: Frank H. van Tiel, MD, PhD University Hospital Maastricht, Maastricht, the Netherlands
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00367588     History of Changes
Other Study ID Numbers: TN3 / CvZ nr.01111
Study First Received: August 22, 2006
Last Updated: October 19, 2006
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
chemotherapy
diet
hematological malignancy
infection prevention
protective isolation
Patients with cytopenia due to intensive chemotherapy for hematological malignancy

Additional relevant MeSH terms:
Anemia
Leukopenia
Pancytopenia
Thrombocytopenia
Hematologic Neoplasms
Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014