Clinical Trial: Low Bacterial Diet in Patients With Cytopenia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy
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 Summary:
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.
Sponsor: Maastricht University Medical Center
Current Primary Outcome: Colonization of the gut by aerobic Gram negative rods and yeasts
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The occurrence of infections
- The total societal costs
Original Secondary Outcome: Same as current
Information By: Maastricht University Medical Center
Dates:
Date Received: August 22, 2006
Date Started:
Date Completion: June 2004
Last Updated: October 24, 2016
Last Verified: June 2004
