Van Tiel, F.H., Harbers, M.M., Terporten, P.H.W., van Boxtel, R.T.C., Kessels, A.G., & Voss, G.B. (2007). Normal hospital and low-bacterial diet in patients with cytopenia after intensive chemotherapy for hematologic malignancy: A study of safety. Annals of Oncology, 18, 1080–1084.

Adult patients with acute leukemia receiving remission-induction chemotherapy.
Patients received either antibacterial prophylaxis (AP) and low-microbial diet (LBD) or AP and normal hospital diet (NHD) to prevent infections.

Patients were randomized into two groups.

• Patients receiving antibiotic prophylaxis (AP) and low-bacterial diet (LBD)
• Patients receiving AP and normal hospital diet (NHD).  

AP included ciprofloxacin 500 mg every 12 hours and oral fluconazole 50 mg every 24 hours and was started before initiation of chemotherapy and discontinued when leukocyte counts recovered to 1,000/mm³ or higher.

• The total sample size was 20 (15 men and 5 women).
• All were patients with acute leukemia undergoing remission-induction chemotherapy.

Randomized, controlled pilot study

• Infection was measured by gastrointestinal tract colonization with yeast or gram-negative bacilli or fever higher than 38ºC.
• Stool was measured daily for bacterial colonization.  
• A Student's t test compared degree of colonization between the two groups. Differences at cycle-specific points in time were evaluated with a multivariate analysis of variance (MANOVA). Differences in temperature were measured by the Fisher’s exact test.

No statistically significant differences were found between the two groups for rates of infection.

• The small pilot study and sample size were inadequate to observe significant differences between the study groups.
• The study did not measure whether patients were adherent to their assigned diets.  
• Randomization could not create two equal groups.  
• Patients received AP.
• Results cannot be generalized because of the small sample size.