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

27 de mayo de 2026 actualizado por: 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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

252

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Suecia
      • Gothenburg, Suecia, 413 45
        • Reclutamiento
        • Mag-tarmlab, Sahlgrenska University Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention
Adults with IBS who have been randomized to receive the intervention
Otro: Probiotic Supplementation (Lactobacillus Reuteri)
Probiotic using a new strain derived from L. reuteri.
Comparador de placebos: Control
Adults with IBS who have been randomized to receive the placebo
Otro: Placebo Supplementation
A placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
IBS symptom severity (IBS-Symptom-Severity-Score)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
General global assessment: satisfactory adequate relief of symptoms from baseline to end of intervention between arms
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Validation of the measurement of oro-anal transit time using sweetcorn vs radiopaque markers
Periodo de tiempo: Baseline to end of intervention (12 weeks)
Baseline to end of intervention (12 weeks)
Fecal samples
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sahlgrenska University Hospital

Investigadores

  • Investigador principal: Magnus Simren, MD PHD, Göteborg University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de abril de 2026

Finalización primaria (Estimado)

1 de abril de 2031

Finalización del estudio (Estimado)

1 de mayo de 2031

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BIO-IBS 2025-04788-01-805801

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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