100
Participants
Start Date
May 12, 2021
Primary Completion Date
November 29, 2022
Study Completion Date
November 29, 2022
NZ-GHMH-01
Each randomized subject will consume 1 capsule daily bringing 100 mg (≥ 2 x 109 CFU) of active ingredient during 16 weeks (from V2 to V5 visits).
Placebo
Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).
Clinical Investigation Unit Biofortis, Saint-Herblain
Clinical Investigation Unit Paris, Paris
"Suceava County Hospital - Spitalul Județean de Urgență Sfântul Ioan cel Nou", Suceava
Neomed Brasov, Brasov
"Military Hospital- Spitalul Militar Central Dr Carol Davila", Bucharest
Parhon Institute- Institutul National de Endocrinologie C.I. Parhon, Bucharest
Fundatia Ana Aslan International, Bucharest
CPS Research, Glasgow
Lead Sponsor
Biofortis, Merieux NutriSciences
INDUSTRY
Novozymes A/S
INDUSTRY