ProSem

CompletedPhase NA

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

Lead sponsor

Nordic Biotic Sp. z o.o.

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

102

Study population

Obesity / overweight, Probiotic Intervention, Type 2 diabetes

Eligibility highlights

•BMI ≥30

Primary endpoints

•Gastrointestinal adverse event incidence proportion during semaglutide treatment•Prevalence of gastrointestinal adverse events during semaglutide treatment

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07847593

Org study IDCT/NB/160/2025/PR-MS

Timeline

Milestones

Study start2025-07-09actual

Primary completion2026-07-15actual

Study completion2026-07-15actual

Study first posted2026-09-29actual

Last update posted2026-10-08actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightProbiotic InterventionType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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,

•pregnancy or breastfeeding,

•anemia and leukocytosis in laboratory tests,

•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 antibiotics within the last 1 month,

•the use of the following drugs: insulin, glucocorticosteroids, proton pump blockers,

•a surgical procedure scheduled during the clinical study,

•being enrolled in another clinical trial within the last 3 months,

•alcohol or substance abuse.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight During Semaglutide Treatment

Time frame:Baseline (before initiation of semaglutide treatment) and during scheduled study visits through Week 12

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Health-Related Quality of Life

Time frame:Baseline (before initiation of semaglutide treatment) and Week 12 (end of semaglutide treatment)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Gastrointestinal adverse event incidence proportion during semaglutide treatment

Time frame:During the 12-week semaglutide treatment and dose-escalation period

threshold achievement, event

Primary/protocol endpoint

Prevalence of gastrointestinal adverse events during semaglutide treatment

Time frame:During the 12-week semaglutide treatment and dose-escalation period

descriptive

Secondary/protocol endpoint

Severity of Selected Gastrointestinal Adverse Events

Time frame:From initiation of semaglutide treatment through Week 12

descriptive

Secondary/protocol endpoint

Number of Days With Individual Gastrointestinal Symptoms

Time frame:From initiation of semaglutide treatment through Week 12

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Number of Participants Who Discontinued Semaglutide Treatment

Time frame:From initiation of semaglutide treatment through Week 12

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Number of Participants Unable to Escalate Semaglutide Dose According to the Planned Schedule

Time frame:From initiation of semaglutide treatment through Week 12

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.