Obesity (Disorder)ProSemNCT07847593
Probiotics in Obese Patients Treated With Semaglutide
A study testing Four-strain probiotic formulation in people with Obesity (Disorder) and GLP-1 Receptor Agonist Treatment, run by Nordic Biotic Sp. z o.o. at 3 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity (Disorder), GLP-1 Receptor Agonist Treatment, Probiotic Intervention
- What is being tested?
- Four-strain probiotic formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 3 sitesPoland
- Study dates
- 9 Jul 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
The Clinic Centrum Medyczne
Gdynia, 81-521
Prywatna Specjalistyczna Praktyka Lekarska
Grudziądz, 86-300
NEUROMEDIKA Indywidualna Specjalistyczna Praktyka Lekarska
Pruszcz Gdański, 83-000
About this study
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
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.
Read the detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are effective pharmacological treatments for obesity. Semaglutide acts through multiple mechanisms, including enhancement of satiety, reduction of appetite, slowing of gastric emptying, stimulation of glucose-dependent insulin secretion, and suppression of glucagon secretion. Clinical studies have demonstrated that semaglutide can produce clinically meaningful body weight reduction and improve glycemic and other cardiometabolic outcomes. However, treatment is frequently associated with gastrointestinal adverse events, particularly during dose escalation. Commonly reported gastrointestinal adverse events include nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating.
The gut microbiota may influence gastrointestinal function, intestinal barrier integrity, host metabolism, and inflammatory processes. Selected probiotic strains may therefore have the potential to support gastrointestinal function and improve treatment tolerability. This provided the rationale for evaluating a specifically selected probiotic formulation as a supportive intervention in adults with obesity receiving semaglutide.
This was a randomized, double-blind, placebo-controlled, parallel-group interventional trial conducted in adults with obesity. Participants were randomly assigned to receive either a four-strain probiotic formulation or a matching placebo. The probiotic formulation contained Bifidobacterium animalis subsp. lactis AZHx1, Limosilactobacillus reuteri AZHx2, Lacticaseibacillus casei AZHx3, and Lacticaseibacillus rhamnosus AZHx4.
The assigned probiotic or placebo was initiated two weeks before the first dose of semaglutide and continued throughout the subsequent 12-week semaglutide-treatment period. Semaglutide was administered once weekly according to a stepwise dose-escalation schedule: 0.25 mg during weeks 1-4, 0.5 mg during weeks 5-8, and 1.0 mg during weeks 9-12.
Gastrointestinal tolerability was assessed using two complementary sources of information: investigator assessments performed at scheduled study visits and prospective daily symptom reporting by participants using diaries. Visit V1 marked semaglutide initiation after the scheduled assessment, and follow-up assessments were performed at Visits V2-V4 during the subsequent 12-week dose-escalation period. Participant diaries provided daily observations throughout 2 weeks of pretreatment probiotic/placebo supplementation and the 12 weeks of semaglutide treatment.
The co-primary outcomes were two complementary measures assessed during the 12-week semaglutide-treatment period:
- Gastrointestinal adverse event incidence proportion, defined as the percentage of participants reporting at least one protocol-defined gastrointestinal adverse event during the 7-day recall windows preceding scheduled follow-up visits V2-V4; and
- Gastrointestinal adverse event prevalence, defined for each participant as the percentage of evaluable semaglutide-treatment days on which at least one protocol-defined gastrointestinal adverse event was recorded in the daily diary.
Protocol-defined gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating.
Secondary outcomes included the severity of individual gastrointestinal symptoms, the number of days with individual protocol-defined gastrointestinal adverse events, health-related quality of life, change in body weight, discontinuation of semaglutide treatment, and inability to escalate the semaglutide dose according to the planned schedule. Additional gastrointestinal complaints and non-gastrointestinal symptoms were monitored as part of safety assessment. Outcomes were compared between participants receiving semaglutide in combination with the probiotic formulation and those receiving semaglutide in combination with placebo.
- Conditions
- Obesity (Disorder), GLP-1 Receptor Agonist Treatment, Probiotic Intervention, Diabetes Mellitus Type 2
- Being tested
- Four-strain probiotic formulation, Maltodextrin (Placebo)
- Keywords
- Obesity, GLP-1 receptor agonist treatment, Gatro-intestinal adverse events, Probiotics, Diabetes mellitus type 2
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-strain probiotic formulationDietary supplement
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)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants assigned to this arm received the probiotic formulation in addition to semaglutide treatment. Receives: Dietary Supplement: Four-strain probiotic formulation |
| Placebo | Placebo comparator | Participants assigned to this arm received a matching placebo containing maltodextrin in addition to semaglutide treatment. Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal adverse event incidence proportion during semaglutide treatment
The gastrointestinal adverse event incidence proportion was defined as the percentage of participants reporting at least one protocol-defined gastrointestinal adverse event during the 7-day recall windows preceding Visits V2-V4 over the 12-week semaglutide-treatment period. Gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating. Each participant was counted once, regardless of whether the symptom was reported at more than one visit or had been present before semaglutide initiation. The possible range was 0%-100%, with higher values indicating a higher proportion of participants reporting gastrointestinal adverse events.
Measured: During the 12-week semaglutide treatment and dose-escalation period
Prevalence of gastrointestinal adverse events during semaglutide treatment
Gastrointestinal adverse event prevalence was defined for each participant as the percentage of evaluable days during the 12-week semaglutide-treatment period on which at least one protocol-defined gastrointestinal adverse was recorded in the daily diary. Gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating. A day with more than one gastrointestinal adverse event was counted once for the overall prevalence. Prevalence was calculated as the number of evaluable days with at least one gastrointestinal adverse event divided by the total number of evaluable days for that participant, multiplied by 100. Group results were summarized as the mean participant-level prevalence. The possible range was 0%-100%.
Measured: During the 12-week semaglutide treatment and dose-escalation period
Secondary outcomes (6)
Change in Health-Related Quality of Life
Health-related quality of life was assessed using the the 36-Item Short Form Health Survey, version 2 (SF-36v2) at baseline, before initiation of semaglutide treatment, and at the end of the 12-week semaglutide-treatment period. SF-36v2 scores were calculated using the licensed IQVIA PRO CoRE scoring software according to the standardized scoring algorithm. The assessment included the eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health, as well as the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Changes from baseline to Week 12 were evaluated and compared between treatment groups. Higher scores indicate better health-related quality of life.
Measured: Baseline (before initiation of semaglutide treatment) and Week 12 (end of semaglutide treatment)
Severity of Selected Gastrointestinal Adverse Events
The severity of three selected gastrointestinal adverse events-abdominal pain, bloating and nausea-was assessed during the 12-week semaglutide-treatment period. Symptom severity was assessed at scheduled study visits and was also recorded prospectively by participants in daily diaries throughout the treatment period.
For each of the three symptoms, severity was rated using a 4-point Likert scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicated greater symptom severity. Severity of the individual symptoms was compared between the probiotic and placebo groups.
Measured: From initiation of semaglutide treatment through Week 12
Number of Days With Individual Gastrointestinal Symptoms
The number of days with individual gastrointestinal adverse events was assessed prospectively using participant-completed daily diaries during the 12-week semaglutide-treatment period. Events included abdominal pain, bloating, nausea, diarrhea, constipation, and vomiting. Abdominal pain, bloating, and nausea were rated daily on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe); scores greater than 0 indicated symptom presence, and scores of 2 or 3 indicated moderate or severe symptoms. Diarrhea and constipation were defined using the Bristol Stool Form Scale as stool types 6-7 and 1-2, respectively; vomiting required an explicit diary entry. For each participant, the number of days with each individual gastrointestinal adverse event was determined. For abdominal pain, bloating, and nausea, the number of days with moderate or severe symptoms (severity score ≥2) was also determined. Higher numbers of symptomatic days indicated a greater gastrointestinal symptom burden.
Measured: From initiation of semaglutide treatment through Week 12
Change in Body Weight During Semaglutide Treatment
Body weight was measured by the investigator at each scheduled study visit during the 12-week semaglutide-treatment and dose-escalation period. Change in body weight from baseline, defined as the assessment before initiation of semaglutide treatment, was evaluated over time and at Week 12. Body weight was measured in kilograms, with greater decreases from baseline indicating greater weight loss. Changes in body weight were compared between the probiotic and placebo groups.
Measured: Baseline (before initiation of semaglutide treatment) and during scheduled study visits through Week 12
Number of Participants Who Discontinued Semaglutide Treatment
The number of participants who discontinued semaglutide treatment for any reason during the 12-week treatment and dose-escalation period was recorded. Treatment discontinuation was assessed by investigators at scheduled study visits. The outcome was expressed as the number and proportion of participants who discontinued semaglutide before completion of the 12-week treatment period.
Measured: From initiation of semaglutide treatment through Week 12
Number of Participants Unable to Escalate Semaglutide Dose According to the Planned Schedule
The number of participants who were unable to escalate the semaglutide dose according to the planned treatment schedule was recorded during the 12-week treatment period. The planned dose-escalation schedule was 0.25 mg once weekly during Weeks 1-4, 0.5 mg once weekly during Weeks 5-8, and 1.0 mg once weekly during Weeks 9-12. Failure to escalate was defined as inability to advance to the next planned dose level according to the study schedule. The outcome was expressed as the number and proportion of affected participants.
Measured: From initiation of semaglutide treatment through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start9 Jul 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Biotic Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dagmara Hering, Prof. MD, PhD, Principal investigator, Medical University of Gdansk, Department of Hypertension and Diabetology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847593
- Sponsor's protocol ID
- CT/NB/160/2025/PR-MS
- Acronym
- ProSem
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07847593
- Acronym / sponsor ID
- ProSem / CT/NB/160/2025/PR-MS
- Conditions
- Obesity (Disorder), GLP-1 Receptor Agonist Treatment, Probiotic Intervention, Diabetes Mellitus Type 2
- Keywords
- Obesity, GLP-1 receptor agonist treatment, Gatro-intestinal adverse events, Probiotics, Diabetes mellitus type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Nordic Biotic Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), including semaglutide, are effective pharmacological treatments for obesity. Semaglutide acts through multiple mechanisms, including enhancement of satiety, reduction of appetite, slowing of gastric emptying, stimulation of glucose-dependent insulin secretion, and suppression of glucagon secretion. Clinical studies have demonstrated that semaglutide can produce clinically meaningful body weight reduction and improve glycemic and other cardiometabolic outcomes. However, treatment is frequently associated with gastrointestinal adverse events, particularly during dose escalation. Commonly reported gastrointestinal adverse events include nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating.
The gut microbiota may influence gastrointestinal function, intestinal barrier integrity, host metabolism, and inflammatory processes. Selected probiotic strains may therefore have the potential to support gastrointestinal function and improve treatment tolerability. This provided the rationale for evaluating a specifically selected probiotic formulation as a supportive intervention in adults with obesity receiving semaglutide.
This was a randomized, double-blind, placebo-controlled, parallel-group interventional trial conducted in adults with obesity. Participants were randomly assigned to receive either a four-strain probiotic formulation or a matching placebo. The probiotic formulation contained Bifidobacterium animalis subsp. lactis AZHx1, Limosilactobacillus reuteri AZHx2, Lacticaseibacillus casei AZHx3, and Lacticaseibacillus rhamnosus AZHx4.
The assigned probiotic or placebo was initiated two weeks before the first dose of semaglutide and continued throughout the subsequent 12-week semaglutide-treatment period. Semaglutide was administered once weekly according to a stepwise dose-escalation schedule: 0.25 mg during weeks 1-4, 0.5 mg during weeks 5-8, and 1.0 mg during weeks 9-12.
Gastrointestinal tolerability was assessed using two complementary sources of information: investigator assessments performed at scheduled study visits and prospective daily symptom reporting by participants using diaries. Visit V1 marked semaglutide initiation after the scheduled assessment, and follow-up assessments were performed at Visits V2-V4 during the subsequent 12-week dose-escalation period. Participant diaries provided daily observations throughout 2 weeks of pretreatment probiotic/placebo supplementation and the 12 weeks of semaglutide treatment.
The co-primary outcomes were two complementary measures assessed during the 12-week semaglutide-treatment period:
- Gastrointestinal adverse event incidence proportion, defined as the percentage of participants reporting at least one protocol-defined gastrointestinal adverse event during the 7-day recall windows preceding scheduled follow-up visits V2-V4; and
- Gastrointestinal adverse event prevalence, defined for each participant as the percentage of evaluable semaglutide-treatment days on which at least one protocol-defined gastrointestinal adverse event was recorded in the daily diary.
Protocol-defined gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating.
Secondary outcomes included the severity of individual gastrointestinal symptoms, the number of days with individual protocol-defined gastrointestinal adverse events, health-related quality of life, change in body weight, discontinuation of semaglutide treatment, and inability to escalate the semaglutide dose according to the planned schedule. Additional gastrointestinal complaints and non-gastrointestinal symptoms were monitored as part of safety assessment. Outcomes were compared between participants receiving semaglutide in combination with the probiotic formulation and those receiving semaglutide in combination with placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Four-strain probiotic formulationParticipants assigned to this arm received the probiotic formulation in addition to semaglutide treatment. |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)Participants assigned to this arm received a matching placebo containing maltodextrin in addition to semaglutide treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four-strain probiotic formulationThe 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. | Dietary supplement | Probiotic |
| 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. | Dietary supplement | Placebo |
Primary outcome
Gastrointestinal adverse event incidence proportion during semaglutide treatment
Time frame: During the 12-week semaglutide treatment and dose-escalation period
The gastrointestinal adverse event incidence proportion was defined as the percentage of participants reporting at least one protocol-defined gastrointestinal adverse event during the 7-day recall windows preceding Visits V2-V4 over the 12-week semaglutide-treatment period. Gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating. Each participant was counted once, regardless of whether the symptom was reported at more than one visit or had been present before semaglutide initiation. The possible range was 0%-100%, with higher values indicating a higher proportion of participants reporting gastrointestinal adverse events.
Prevalence of gastrointestinal adverse events during semaglutide treatment
Time frame: During the 12-week semaglutide treatment and dose-escalation period
Gastrointestinal adverse event prevalence was defined for each participant as the percentage of evaluable days during the 12-week semaglutide-treatment period on which at least one protocol-defined gastrointestinal adverse was recorded in the daily diary. Gastrointestinal adverse events included nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating. A day with more than one gastrointestinal adverse event was counted once for the overall prevalence. Prevalence was calculated as the number of evaluable days with at least one gastrointestinal adverse event divided by the total number of evaluable days for that participant, multiplied by 100. Group results were summarized as the mean participant-level prevalence. The possible range was 0%-100%.
6 secondary outcomes
Change in Health-Related Quality of Life
Time frame: Baseline (before initiation of semaglutide treatment) and Week 12 (end of semaglutide treatment)
Severity of Selected Gastrointestinal Adverse Events
Time frame: From initiation of semaglutide treatment through Week 12
Number of Days With Individual Gastrointestinal Symptoms
Time frame: From initiation of semaglutide treatment through Week 12
Change in Body Weight During Semaglutide Treatment
Time frame: Baseline (before initiation of semaglutide treatment) and during scheduled study visits through Week 12
Number of Participants Who Discontinued Semaglutide Treatment
Time frame: From initiation of semaglutide treatment through Week 12
Number of Participants Unable to Escalate Semaglutide Dose According to the Planned Schedule
Time frame: From initiation of semaglutide treatment through Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dagmara Hering, Prof. MD, PhD principal investigator
Medical University of Gdansk, Department of Hypertension and Diabetology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-strain probiotic formulation in people with Obesity (Disorder) and GLP-1 Receptor Agonist Treatment, run by Nordic Biotic Sp. z o.o. at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal adverse event incidence proportion during semaglutide treatment (time frame: During the 12-week semaglutide treatment and dose-escalation period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.