Table 3.

Comparison of trials evaluating oxalate decarboxylase enzymes in healthy volunteers

Langman et al. (19)This Study
Study product
 Recombinant OxDC originating from Bacillus subtilisRecombinant OxDC originating from Synechoccus elongates
 Capsule formatSachet format
 1500 U per capsule1000 U per sachet
 Five capsules per doseOne sachet per dose
Participants
 33 healthy volunteer enrolled33 healthy volunteers enrolled
 30 healthy volunteers completed study33 healthy volunteers completed study
 27:6 men:women17:16 men:women
 Average age 39.7 (10.7)Average age 36.2 (12.27)
 Average BMI: 24.9Average BMI: 24.9
 Baseline Uox: 80.8 mg/24 hBaseline Uox: 44.7 mg/24 h
 Screen Uox: 27.2 mg/24 hScreen Uox: 19.8 mg/24 h
Study design
 Double blindDouble blind
 RandomizedRandomized
 Placebo controlledPlacebo controlled
 CrossoverCrossover
 Inpatient studyInpatient study
 Treatment period: 7 dTreatment period: 2 d
 Washout period: 7 dWashout period: 2 d
 Follow-up visit: 7 dFollow-up visit: none
 Diet oxalate: 1000 mg/dDiet oxalate: 750 mg/d
 Diet calcium: 400 mg/dDiet calcium: 550 mg/d
 Outcome measured over last 4 d of 7-d treatment periodOutcome measured over the 2 d of treatment period
 Interim analysisNo interim analysis
 22,500 U/d3000 U/d
  • OxDC, oxalate decarboxylase; BMI, body mass index; Uox, mean urinary oxalate.