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Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy

18 Years
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Trial Information

Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Colonization of the gut by aerobic Gram negative rods and yeasts

Principal Investigator

Frank H. van Tiel, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Maastricht, Maastricht, the Netherlands


Netherlands: Medical Ethics Review Committee (METC)

Study ID:

TN3 / CvZ nr.01111



Start Date:

Completion Date:

June 2004

Related Keywords:

  • Cytopenia
  • chemotherapy
  • diet
  • hematological malignancy
  • infection prevention
  • protective isolation
  • Patients with cytopenia due to intensive chemotherapy for hematological malignancy
  • Anemia
  • Leukopenia
  • Pancytopenia
  • Thrombocytopenia
  • Hematologic Neoplasms