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Probiotics and Biomarkers in Irritable Bowel Syndrome (BIO-IBS)

27 maja 2026 zaktualizowane przez: Magnus Simrén, Sahlgrenska University Hospital

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?

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

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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

1. 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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

252

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Szwecja
      • Gothenburg, Szwecja, 413 45
        • Rekrutacyjny
        • Mag-tarmlab, Sahlgrenska University Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention
Adults with IBS who have been randomized to receive the intervention
Inny: Probiotic Supplementation (Lactobacillus Reuteri)
Probiotic using a new strain derived from L. reuteri.
Komparator placebo: Control
Adults with IBS who have been randomized to receive the placebo
Inny: Placebo Supplementation
A placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
IBS symptom severity (IBS-Symptom-Severity-Score)
Ramy czasowe: 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
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
General global assessment: satisfactory adequate relief of symptoms from baseline to end of intervention between arms
Ramy czasowe: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
The proportion of individuals with greater or equal to 50% of assessments with an adequate relief of symptoms
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
Ramy czasowe: During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
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
During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS)
Ramy czasowe: 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

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
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
IBS-quality of life (IBS-QoL)
Ramy czasowe: 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 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
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)
Ramy czasowe: 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 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
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
Ramy czasowe: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
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.
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
Ramy czasowe: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
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.
Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)
Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: 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 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
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)
Ramy czasowe: 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 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
Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Validation of the measurement of oro-anal transit time using sweetcorn vs radiopaque markers
Ramy czasowe: Baseline to end of intervention (12 weeks)
Baseline to end of intervention (12 weeks)
Fecal samples
Ramy czasowe: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Fecal samples will be analysed in relation to factors regarding predictors of IBS symptoms and response to intervention (including gut microbiome and fecal metabolites)
Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Urine samples
Ramy czasowe: Baseline (day 0 of intervention)
Urine samples will be analysed in relation to factors regarding predictors of IBS symptoms (including urinary metabolites)
Baseline (day 0 of intervention)
Saliva samples
Ramy czasowe: Baseline (day 0 of intervention)
Saliva samples will be analysed in relation to factors regarding predictors of IBS symptoms (including salivary protease)
Baseline (day 0 of intervention)
Dietary intake - 3 day diet diaries
Ramy czasowe: 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
Dietary intake will be recorded prior to and throughout the study period in seven 3-day diet diaries and analysed in relation to predictors of IBS symptoms and response to intervention
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
Unprepared sigmoidoscopy (+ biopsy and blood serum to measure permeability) with confocal laser endomicroscopy (CLE)
Ramy czasowe: After screening, but pre-randomization (60 - 15 days pre-randomization)
This is an opt-in outcome for participants to ascertain gut permeability in relation to IBS symptom predictors
After screening, but pre-randomization (60 - 15 days pre-randomization)
MRI colon to measure colonic gas volumes
Ramy czasowe: After screening, but pre-randomization (60 - 15 days pre-randomization)
This is an opt-in outcome for participants to ascertain colonic gas volumes in relation to IBS symptom predictors
After screening, but pre-randomization (60 - 15 days pre-randomization)
Small bowel motility MRI
Ramy czasowe: After screening, but pre-randomization (60 - 15 days pre-randomization)
This is an opt-in outcome for participants to ascertain small bowel motility in relation to IBS symptom predictors
After screening, but pre-randomization (60 - 15 days pre-randomization)
ROME V
Ramy czasowe: Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention

Changes in stool consistency and frequency measured using the ROME V questionnaire

The ROME V is a diagnostic questionnaire for disorders of the gut-brain interaction. Changes in stool consistency and frequency are related to a subset of questions in the Rome V (Q54 - 60). Items are rated on a 10-point Likert scale rated as a percentage of 0 - 100% regarding frequency of symptoms in the last 3 months, including: abdominal pain/ discomfort, how often abdominal pain happened close in time to a bowel movement, how often stools were harder than usual, how often stools were softer than usual, how often stools were more frequent than usual, and how often stools were less frequent than usual.
Baseline (day 0 of intervention), during intervention (days 14, 28, 42, 56, 70), end of intervention (day 84), 3 month follow up post intervention
Rectal sensitivity barostat
Ramy czasowe: After screening, but pre-randomization (60 - 15 days pre-randomization)

This is an opt-in outcome for participants to ascertain rectal sensitivity in relation to IBS symptom predictors.

A balloon is inserted and inflated in the rectum in a controlled setting. The patient indicates when defined sensory thresholds are reached (first feeling of the balloon, urge to empty bowel, discomfort or pain). When the patient indicates discomfort or pain, or another reason to stop, the balloon inflation will be stopped.
After screening, but pre-randomization (60 - 15 days pre-randomization)
Rectal sensitivity with Physical Reactions to Emotions Scale (PRES)
Ramy czasowe: After screening, but pre-randomization (60 - 15 days pre-randomization)

This is an opt-in outcome for participants to ascertain rectal sensitivity in relation to IBS symptom predictors

Alongside the rectal barostat, participants will complete the PRES, a 9-item questionnaire measured on a 4-item Likert scale. Total scores can range from 0 = 27 with higher scores indicating more frequent physical reactions to the rectal barostat
After screening, but pre-randomization (60 - 15 days pre-randomization)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Sahlgrenska University Hospital

Śledczy

  • Główny śledczy: Magnus Simren, MD PHD, Göteborg University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

28 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2031

Ukończenie studiów (Szacowany)

1 maja 2031

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BIO-IBS 2025-04788-01-805801

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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