Normal hospital and low-bacterial diet in patients with cytopenia after intensive chemotherapy for hematological malignancy: a study of safety.
BACKGROUND
The purpose of this randomized, controlled pilot study is to address the question whether normal hospital diet (NHD) is safe when compared with low-bacterial diet (LBD) given to prevent infections in cytopenic patients who receive antimicrobial prophylaxis (AP).


METHODS
The patients were randomized into two groups: one group to receive AP and LBD, the other to receive the same AP and NHD. The primary outcome parameter is colonization of the digestive tract with aerobic gram-negative bacilli and yeasts. Secondary outcome parameters were infections and total societal costs.


RESULTS
No statistically significant differences between treatment groups were observed regarding the primary outcome parameter, gut colonization by yeasts or gram-negative bacilli, or infections, use of antimicrobials, days with fever and total societal costs.


CONCLUSIONS
On the basis of the results of this pilot study, NHD appears to be as safe as LBD in patients with chemotherapy-induced cytopenia. Furthermore, the results indicate that LBD may offer no additional benefit as an infection preventive measure to the measures already implemented, such as AP. Thus, a larger randomized study, powered adequately to determine noninferiority of NHD to LBD is warranted and safe to be carried out.
van Tiel
F
F
Maastricht Infection Center, Department of Medical Microbiology, University; Hospital Maastricht, Maastricht, the Netherlands. fvt@lmib.azm.nl
Harbers
M M
MM
Terporten
P H W
PH
van Boxtel
R T C
RT
Kessels
A G
AG
Voss
G B W E
GB
Schouten
H C
HC
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced* / Q000517:prevention & control; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001424:Bacterial Infections / Q000517:prevention & control*; D004032:Diet; D005243:Feces / Q000382:microbiology; D005260:Female; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D007239:Infections / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012449:Safety; D016896:Treatment Outcome
D000970:Antineoplastic Agents