Probiotics and Biomarkers in Irritable Bowel Syndrome
ConditionIrritable Bowel Syndrome (IBS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Supplementation (Lactobacillus Reuteri)
Other interventionProbiotic using a new strain derived from L. reuteri.
Placebo Supplementation
Other interventionA placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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 interventionSecondary outcomes
1
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
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 intervention2
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
Time frame
During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)3
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
Time frame
During intervention (days 14, 28, 42, 56, 70), end of intervention (day 84)4
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
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 interventionOther outcomes
1
ROME V
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.
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 intervention2
Validation of the measurement of oro-anal transit time using sweetcorn vs radiopaque markers
Time frame
Baseline to end of intervention (12 weeks)3
Fecal samples
Fecal samples will be analysed in relation to factors regarding predictors of IBS symptoms and response to intervention (including gut microbiome and fecal metabolites)
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 intervention4
Urine samples
Urine samples will be analysed in relation to factors regarding predictors of IBS symptoms (including urinary metabolites)
Time frame
Baseline (day 0 of intervention)Sponsors and contacts
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Source ClinicalTrials.gov