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Life sciences · Interventional Study
ClinicalTrials.gov · October 8, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07847593). This is a study registration, not published results. Lead sponsor: Nordic Biotic Sp. z o.o.. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 102 participants (ACTUAL). Conditions: Obesity (Disorder), GLP-1 Receptor Agonist Treatment, Probiotic Intervention, Diabetes Mellitus Type 2. Interventions: DIETARY_SUPPLEMENT: Four-strain probiotic formulation; DIETARY_SUPPLEMENT: Maltodextrin (Placebo). Primary outcome measures: Gastrointestinal adverse event incidence proportion during semaglutide treatment , During the 12-week semaglutide treatment and dose-escalation period; Prevalence of gastrointestinal adverse events during semaglutide treatment , During the 12-week semaglutide treatment and dose-escalation period. Brief 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.