28
Participants
Start Date
December 31, 2013
Primary Completion Date
January 31, 2015
Study Completion Date
January 31, 2015
Oxabact OC5 capsules
The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.
Placebo capsules
An enteric-coated placebo capsule manufactured to mimic the OC5 capsule. The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks.
Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest (SORARE), CHU de Bordeaux, Bordeaux
Hôpital Necker-Enfants Malades,Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA), Paris
Hôpital Robert-Debré, Néphrologie Pédiatrique, Paris
Hôpital Femme Mère Enfant, Lyon - Paediatric Dept, Lyon
Universitätsklinikum Bonn, Dept of Paediatric Nephrology, Bonn
Birmingham Children's Hospital NHS Foundation Trust - Dept of Nephrology, Birmingham
Royal Free Hospital -UCL Centre for Nephrology, London
Great Ormond Street Hospital for Children NHS Trust, London
Lead Sponsor
FP7-SME-2013 Research for the benefit of SMEs program
UNKNOWN
OxThera
INDUSTRY