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Probiotics in Obese Patients Treated With Semaglutide
Sponsor: Nordic Biotic Sp. z o.o.
Summary
This randomized, double-blind, placebo-controlled trial evaluated the effects of a four-strain probiotic formulation in adults with obesity receiving semaglutide. Participants received either the probiotic formulation or placebo, beginning two weeks before semaglutide initiation and continuing throughout the 12-week semaglutide-treatment and dose-escalation period. The primary objective was to determine whether probiotic supplementation reduced gastrointestinal adverse events associated with semaglutide treatment. The primary outcome comprised two complementary measures during the 12-week semaglutide-treatment period: the proportion of participants reporting at least one protocol-defined gastrointestinal adverse event during scheduled study visits and the proportion of evaluable treatment days on which a participant reported at least one protocol-defined gastrointestinal adverse event in the daily diary. Secondary outcomes included gastrointestinal symptom severity, the number of days with individual gastrointestinal adverse events, health-related quality of life, change in body weight, treatment discontinuation, and inability to escalate the semaglutide dose as planned. Additional gastrointestinal complaints and non-gastrointestinal symptoms were monitored as part of safety assessment.
Official title: The Effect of Probiotics on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Therapy in Patients With Obesity: A Randomized, Double-Blind, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2025-07-09
Completion Date
2026-07-15
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Four-strain probiotic formulation
The probiotic formulation contained Bifidobacterium animalis subsp. lactis AZHx1 (DSM 35201), Limosilactobacillus reuteri AZHx2 (DSM 35202), Lacticaseibacillus casei AZHx3 (DSM 35185), and Lacticaseibacillus rhamnosus AZHx4 (DSM 35757). It was administered orally in capsule form twice daily, at a total daily dose of 80 billion colony-forming units. Supplementation was initiated two weeks before the first dose of semaglutide and continued throughout the subsequent 12-week semaglutide-treatment and dose-escalation period, resulting in a total supplementation period of 14 weeks.
Maltodextrin (Placebo)
The placebo contained maltodextrin and was matched to the probiotic formulation in appearance, packaging, and administration schedule. It was administered orally in capsule form twice daily for 14 weeks, beginning two weeks before the first dose of semaglutide and continuing throughout the subsequent 12-week semaglutide-treatment and dose-escalation period.
Locations (3)
The Clinic Centrum Medyczne
Gdynia, Poland
Prywatna Specjalistyczna Praktyka Lekarska
Grudziądz, Poland
NEUROMEDIKA Indywidualna Specjalistyczna Praktyka Lekarska
Pruszcz Gdański, Poland