NCT07847593Completed
Probiotics in Obese Patients Treated With Semaglutide
The Effect of Probiotics on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Therapy in Patients With Obesity: A Randomized, Double-Blind, Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 22 Sept 2026
- Start date
- 9 Jul 2025
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07847593
What you commit to
- Study type: Interventional
- Participants enrolled: 102
- From 9 Jul 2025 to the primary completion date, 15 Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- the use of intestine microbiota-targeted dietary supplements or drugs (i.e. probiotics, prebiotics, synbiotics, or postbiotics including butyric acid) within the last 3 months,
- the use of the following drugs: insulin, glucocorticosteroids, proton pump blockers,
- a surgical procedure scheduled during the clinical study,
Other illness
- patients with gastrointestinal conditions unrelated to glucagon-like peptide-1 receptor agonist therapy, such as inflammatory bowel diseases, celiac disease, irritable bowel syndrome, gastroenteritis, gastric and duodenal ulcers, parasitic or bacterial intestinal infestation/infections,
- known food allergies and lactose intolerance,
- severe neurological conditions, malignancy, and hepatic or renal impairment,
Lab values
- anemia and leukocytosis in laboratory tests,
Other
- pregnancy or breastfeeding,
- the use of antibiotics within the last 1 month,
- being enrolled in another clinical trial within the last 3 months,
- alcohol or substance abuse.
Who the study is looking for
- Body Mass Index (BMI) of at least 30 kg/m², with or without coexisting type 2 diabetes mellitus;
- patients initiating treatment with a glucagon-like peptide-1 receptor agonist;
- provided written informed consent;
- patients with ability to adhere to the investigators' instructions regarding study protocol and procedures.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Clinic Centrum Medyczne Coordinator of this site? Confirm its status | Gdynia | Poland | Unknown status |
| Prywatna Specjalistyczna Praktyka Lekarska Coordinator of this site? Confirm its status | Grudziądz | Poland | Unknown status |
| NEUROMEDIKA Indywidualna Specjalistyczna Praktyka Lekarska Coordinator of this site? Confirm its status | Pruszcz Gdański | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.