Irritable Bowel Syndrome (IBS)BIO-IBSNCT07584278
Probiotics and Biomarkers in Irritable Bowel Syndrome
A study testing Probiotic Supplementation (Lactobacillus Reuteri) in people with Irritable Bowel Syndrome (IBS), run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Probiotic Supplementation (Lactobacillus Reuteri)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2026to May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with IBS according to ROME V criteria
- IBS-SSS greater than or equal to 75
- Adult over 18 years old
- BMI 18.5-35 kg/m2
- Able to understand the participant information sheet and willing to comply with the study protocol
- Able to give informed consent
- Able to complete the Swedish questionnaires
Who cannot join
- History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).
- The use of opioids 1 month prior to screening and throughout the study
- The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)
- Consumption of antibiotics 3 months prior to screening and throughout the study
- The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.
- Participation in any medical research during the last month
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- Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug/g as absolute cutoff. If calprotectin is between 50 - 150ug/g the decision is made on clinical judgement)
- Pregnancy, plan to become pregnant during the study, breastfeeding
- alcohol consumption >14 units per week
- Use of recreational active drugs during 1 month before screening or during the study
- Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Mag-tarmlab, Sahlgrenska University Hospital
Gothenburg, 413 45
MagTarmlab, +46 31 342 81 07, magtarmlab.se@vgregion.se
About this study
Official title: The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome
The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:
Does the probiotic alter IBS symptom severity?
Read more
Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.
Participants will:
Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.
Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).
Provide biological samples (blood, stool, saliva, urine) Complete questionnaires
Read the detailed description
The BIO-IBS study is a double-blind, randomized, placebo-controlled clinical trial investigating whether a combination probiotic improves symptoms in adults with irritable bowel syndrome (IBS). The trial also explores biological mechanisms and predictors of treatment response.
Background \& Rationale IBS is a common disorder of gut-brain interaction (~4% prevalence in Sweden). Current treatments include dietary, pharmacological, and psychological approaches. Increasing evidence suggests the gut microbiome plays a key role, prompting interest in probiotics.
Aims
- Evaluate effect of probiotic combination on IBS symptoms. 2, Identify predictors of response. 3. Investigate IBS pathophysiology and biomarkers.
Study Design
Type: Double-blind, randomized, placebo-controlled, parallel-group Participants: 252 adults with IBS Randomization: 1:1 (probiotic vs placebo) Treatment duration: 12 weeks Follow-up: 3 months post-treatment Timeline: Recruitment starting April 2026 lasting ~3 years
Participants Inclusion Criteria
Adult (≥18 years), IBS (Rome IV criteria) IBS-SSS > 75 BMI 18.5-35 Able to consent and complete Swedish questionnaires
Key Exclusion Criteria
Significant gastrointestinal or systemic disease Recent antibiotics (within 3 months) or probiotics (within 2 weeks) Opioid use Pregnancy/breastfeeding Significant lab abnormalities (e.g., high fecal calprotectin) Major lifestyle/treatment changes
Intervention
Active treatment: Tablet containing both L. reuteri strains Placebo: Identical without bacteria Dose: 1 tablet twice daily Duration: 12 weeks Compliance ≥80% required for per-protocol analysis.
Outcomes Primary Outcome
Change in IBS symptom severity (IBS-SSS) from baseline to 12 weeks (intervention vs placebo)
Secondary Outcomes
Proportion achieving ≥50 or ≥100 point IBS-SSS reduction Gastrointestinal symptoms (GSRS-IBS) Pain reduction Quality of life (IBSQOL) Work productivity (WPAI:IBS) Transit time (gut motility) Adverse events Sustainability of effects (3-month follow-up)
Exploratory Outcomes
Stool consistency/frequency Biomarkers (microbiome, immune, metabolomics, etc.) Psychological and lifestyle factors Dietary influences Mechanistic insights into IBS
Study Procedures Visits Screening (2-8 weeks before randomization Consent, questionnaires, biological samples, diaries
Randomization (Day 0) Baseline assessments and start of treatment
During intervention Regular symptom tracking Phone follow-up at week 6
End of treatment (12 weeks) Repeat assessments and samples
Follow-up (3 months later) Long-term outcomes
Optional (Facultative) Assessments Rectal sensitivity (barostat) Sigmoidoscopy ± confocal endomicroscopy MRI (motility and colonic volume)
Measurements
Questionnaires: IBS-SSS, GSRS-IBS, HADS, PHQ-15, IBSQOL, stress, work productivity Biological samples: blood, stool, urine, saliva Gut function: transit time (radiopaque markers and sweetcorn method) Diet: food frequency and recall diaries
Statistical Considerations Sample size: 252 participants (powered to detect clinically meaningful IBS-SSS difference)
Populations:
Intention-to-treat (all randomized) Per-protocol (≥80% compliance, no major deviations) Analysis plan: Defined in a Statistical Analysis Plan No interim analysis
Safety Probiotics considered safe with minimal risk (mainly transient flatulence). Adverse events will be recorded and classified by severity and causality. IBS symptom fluctuations are not counted as adverse events unless worsened.
Ethics \& Data Handling Conducted according to Declaration of Helsinki and ICH-GCP. Participants give informed consent and can withdraw anytime. Data are pseudonymized and securely stored (REDCap)
Risk-Benefit Assessment Low risk due to established safety of L. reuteri strains Moderate participant burden (questionnaires, sample collection) Optional procedures may cause discomfort but are controlled and voluntary Potential benefit: improved IBS symptoms and better understanding of disease mechanisms
Key Strengths Large sample size Rigorous randomized controlled design Comprehensive symptom, biological, and mechanistic assessment Long follow-up
Conclusion This study aims to determine whether a novel probiotic combination improves IBS symptoms and to identify biological and clinical predictors of response, contributing to more personalized treatment strategies in IBS.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Probiotic Supplementation (Lactobacillus Reuteri), Placebo Supplementation
- Keywords
- probiotic, irritable bowel syndome, ibs symptom severity, oro-anal transit time, randomized controlled trial
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Supplementation (Lactobacillus Reuteri)Other
Probiotic using a new strain derived from L. reuteri.
Placebo SupplementationOther
A placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Adults with IBS who have been randomized to receive the intervention Receives: Other: Probiotic Supplementation (Lactobacillus Reuteri) |
| Control | Placebo comparator | Adults with IBS who have been randomized to receive the placebo Receives: Other: Placebo Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom severity (IBS-Symptom-Severity-Score)
- Between group differences (intervention vs control) in mean IBS-SSS scores from baseline to end of intervention.
- Proportion of responders (decrease in IBS-SSS over greater than or equal to 50 points from baseline to end of intervention) between arms
- Proportion of greater responders (decrease in IBS-SSS scores greater than or equal to 100 points from baseline to end of intervention) between arms
Measured: Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Secondary outcomes (9)
Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)
Change in Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS) scores over time between arms
The GSRS uses a 7- point Likert scale. Total scores can range from 15 - 105 with higher scores indicating worse symptom rating
Measured: Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
General global assessment: satisfactory adequate relief of symptoms from baseline to end of intervention between arms
The proportion of individuals with greater or equal to 50% of assessments with an adequate relief of symptoms
Measured: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
General global assessment: worst pain over the last 24 hours, intervention group vs placebo group reduced between baseline and end of intervention between arms
The proportion of individuals with greater or equal to 50% of assessments between baseline and end of intervention, and a greater than or equal to 30% decrease in worst pain during the last 24 hours compared to baseline
Measured: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
IBS-quality of life (IBS-QoL)
Change in IBS-quality of life (IBS-QoL) scores over time between arms
The IBS-QoL is a 34-item scale that uses a 5-point Likert scale with total scores ranging from 0-100, where higher scores indicate better quality of life
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Work Productivity and Activity Impairment:IBS (WPAI:IBS)
Change in Work Productivity and Activity Impairment:IBS (WPAI:IBS) scores over time between arms
The WPAI:IBS consists of 6 items regarding employment status, hours of work missed because of IBS, hours missed because of other reasons, hours actually worked, how much IBS affected productivity of working (VAS of 0 to 10), how much IBS affected regular activities (VAS of 0 to 10). Total scores are expressed as percentage of impairment/productivity lost with higher scores indicating greater impairment
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Change in oro-anal transit time from baseline to end of intervention between groups: Radiopaque markers
Participants will take oral tablets that are radiopaque markers following a specific protocol beginning from 7 days prior to attending the study visit. Each day they will swallow one set of radiopaque markers with water, then on day 7 a nurse will conduct an X-ray of the abdomen to show the location of the markers in the bowel.
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Change in oro-anal transit time from baseline to end of intervention between groups: sweetcorn
Sweetcorn oro-anal transit time will be measured using a specific protocol. 7 days before attending the study visit the participants will be advised to eat 100g of sweetcorn at 0800 with minimal chewing. Following this, each time they open their bowel for the next 6 days they will be advised to visually inspect the stool for sweetcorn and record whether or not they see the sweetcorn in a diary.
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Hospital Anxiety and Depression Scale (HADS)
Change in Hospital Anxiety and Depression Scale (HADS) scores over time between groups.
The HADS is a 14-item questionnaire (with 2 subscales: HADS-Depression (7 items) and HADS-Anxiety (7 items), with each item rated on a 4 point Likert scale. Total scores range from 0 - 21. Higher scores indicate worse symptoms for anxiety and depression
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Patient Health Questionnaire (PHQ)
Change in Patient Health Questionnaire (PHQ) scores over time between groups
The PHQ is a 15-item questionnaire with each item rated on a 3-point Likert scale. Total scores range from 0-30 with higher scores indicating greater somatic symptom burden
Measured: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start28 Apr 2026
- Primary completionApr 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Simrén, Sahlgrenska University Hospital
- Investigators
- Magnus Simren, MD PHD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584278
- Sponsor's protocol ID
- BIO-IBS 2025-04788-01-805801
- Acronym
- BIO-IBS
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 1 Jun 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07584278
- Acronym / sponsor ID
- BIO-IBS / BIO-IBS 2025-04788-01-805801
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- probiotic, irritable bowel syndome, ibs symptom severity, oro-anal transit time, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 13 May 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.
The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:
Does the probiotic alter IBS symptom severity?
Researchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.
Participants will:
Be randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.
Visit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).
Provide biological samples (blood, stool, saliva, urine) Complete questionnaires
Detailed description
The BIO-IBS study is a double-blind, randomized, placebo-controlled clinical trial investigating whether a combination probiotic improves symptoms in adults with irritable bowel syndrome (IBS). The trial also explores biological mechanisms and predictors of treatment response.
Background \& Rationale IBS is a common disorder of gut-brain interaction (~4% prevalence in Sweden). Current treatments include dietary, pharmacological, and psychological approaches. Increasing evidence suggests the gut microbiome plays a key role, prompting interest in probiotics.
Aims
- Evaluate effect of probiotic combination on IBS symptoms. 2, Identify predictors of response. 3. Investigate IBS pathophysiology and biomarkers.
Study Design
Type: Double-blind, randomized, placebo-controlled, parallel-group Participants: 252 adults with IBS Randomization: 1:1 (probiotic vs placebo) Treatment duration: 12 weeks Follow-up: 3 months post-treatment Timeline: Recruitment starting April 2026 lasting ~3 years
Participants Inclusion Criteria
Adult (≥18 years), IBS (Rome IV criteria) IBS-SSS > 75 BMI 18.5-35 Able to consent and complete Swedish questionnaires
Key Exclusion Criteria
Significant gastrointestinal or systemic disease Recent antibiotics (within 3 months) or probiotics (within 2 weeks) Opioid use Pregnancy/breastfeeding Significant lab abnormalities (e.g., high fecal calprotectin) Major lifestyle/treatment changes
Intervention
Active treatment: Tablet containing both L. reuteri strains Placebo: Identical without bacteria Dose: 1 tablet twice daily Duration: 12 weeks Compliance ≥80% required for per-protocol analysis.
Outcomes Primary Outcome
Change in IBS symptom severity (IBS-SSS) from baseline to 12 weeks (intervention vs placebo)
Secondary Outcomes
Proportion achieving ≥50 or ≥100 point IBS-SSS reduction Gastrointestinal symptoms (GSRS-IBS) Pain reduction Quality of life (IBSQOL) Work productivity (WPAI:IBS) Transit time (gut motility) Adverse events Sustainability of effects (3-month follow-up)
Exploratory Outcomes
Stool consistency/frequency Biomarkers (microbiome, immune, metabolomics, etc.) Psychological and lifestyle factors Dietary influences Mechanistic insights into IBS
Study Procedures Visits Screening (2-8 weeks before randomization Consent, questionnaires, biological samples, diaries
Randomization (Day 0) Baseline assessments and start of treatment
During intervention Regular symptom tracking Phone follow-up at week 6
End of treatment (12 weeks) Repeat assessments and samples
Follow-up (3 months later) Long-term outcomes
Optional (Facultative) Assessments Rectal sensitivity (barostat) Sigmoidoscopy ± confocal endomicroscopy MRI (motility and colonic volume)
Measurements
Questionnaires: IBS-SSS, GSRS-IBS, HADS, PHQ-15, IBSQOL, stress, work productivity Biological samples: blood, stool, urine, saliva Gut function: transit time (radiopaque markers and sweetcorn method) Diet: food frequency and recall diaries
Statistical Considerations Sample size: 252 participants (powered to detect clinically meaningful IBS-SSS difference)
Populations:
Intention-to-treat (all randomized) Per-protocol (≥80% compliance, no major deviations) Analysis plan: Defined in a Statistical Analysis Plan No interim analysis
Safety Probiotics considered safe with minimal risk (mainly transient flatulence). Adverse events will be recorded and classified by severity and causality. IBS symptom fluctuations are not counted as adverse events unless worsened.
Ethics \& Data Handling Conducted according to Declaration of Helsinki and ICH-GCP. Participants give informed consent and can withdraw anytime. Data are pseudonymized and securely stored (REDCap)
Risk-Benefit Assessment Low risk due to established safety of L. reuteri strains Moderate participant burden (questionnaires, sample collection) Optional procedures may cause discomfort but are controlled and voluntary Potential benefit: improved IBS symptoms and better understanding of disease mechanisms
Key Strengths Large sample size Rigorous randomized controlled design Comprehensive symptom, biological, and mechanistic assessment Long follow-up
Conclusion This study aims to determine whether a novel probiotic combination improves IBS symptoms and to identify biological and clinical predictors of response, contributing to more personalized treatment strategies in IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Probiotic Supplementation (Lactobacillus Reuteri)Adults with IBS who have been randomized to receive the intervention |
| Control | Placebo comparator | Other: Placebo SupplementationAdults with IBS who have been randomized to receive the placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with IBS according to ROME V criteria
- IBS-SSS greater than or equal to 75
- Adult over 18 years old
- BMI 18.5-35 kg/m2
- Able to understand the participant information sheet and willing to comply with the study protocol
Key exclusion criteria (11 listed)
- History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).
- The use of opioids 1 month prior to screening and throughout the study
- The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)
- Consumption of antibiotics 3 months prior to screening and throughout the study
- The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.
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 |
|---|---|---|
| Probiotic Supplementation (Lactobacillus Reuteri)Probiotic using a new strain derived from L. reuteri. | Other | Intervention |
| Placebo SupplementationA placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present. | Other | Control |
Primary outcome
IBS symptom severity (IBS-Symptom-Severity-Score)
Time frame: Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
* Between group differences (intervention vs control) in mean IBS-SSS scores from baseline to end of intervention. * Proportion of responders (decrease in IBS-SSS over greater than or equal to 50 points from baseline to end of intervention) between arms * Proportion of greater responders (decrease in IBS-SSS scores greater than or equal to 100 points from baseline to end of intervention) between arms
9 secondary outcomes
Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)
Time frame: Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
General global assessment: satisfactory adequate relief of symptoms from baseline to end of intervention between arms
Time frame: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
General global assessment: worst pain over the last 24 hours, intervention group vs placebo group reduced between baseline and end of intervention between arms
Time frame: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
IBS-quality of life (IBS-QoL)
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Work Productivity and Activity Impairment:IBS (WPAI:IBS)
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Change in oro-anal transit time from baseline to end of intervention between groups: Radiopaque markers
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Change in oro-anal transit time from baseline to end of intervention between groups: sweetcorn
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Patient Health Questionnaire (PHQ)
Time frame: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Magnus Simren, MD PHD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Supplementation (Lactobacillus Reuteri) in people with Irritable Bowel Syndrome (IBS), run by Sahlgrenska University Hospital at 1 site in Sweden.
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 7 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Simren, MD, PhD (0046313428107, magnus.simren@medicine.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom severity (IBS-Symptom-Severity-Score) (time frame: Screening (15-60 days pre-intervention), baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention). 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 1 Jun 2026.