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CompletedNCT03986476Updated Sep 9, 2021

The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome

An interventional study of Probiotics and Placebo in IBS, sponsored by Örebro University, Sweden. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-09.

Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will investigate the effects of supplementation with two different probiotic products (Lactobacillus reuteri strains) on the intestinal barrier function, gut health and stress symptoms in diarrhoea-predominant irritable bowel syndrome (IBS-D) patients.

Read the detailed description

After having given their written informed consent, subjects will complete screening procedures to evaluate their eligibility for the study (visit 1). Study participants will undergo two baseline visits (visits 2 and 3, 3 weeks apart) to account for individual variations, and will then be randomly assigned to 6-week intake of one of two Lactobacillus reuteri strains, or placebo in a ratio of 1:1:1 (stratified by sex). Participants will attend a study visit three weeks into the intervention (visit 4) and at the end of the intervention (visit 5, week 6). The intestinal permeability will be assessed using a standardized multi-sugar test at visit 2, visit 3, visit 4, and at end of intervention (visit 5). Blood, saliva and faecal samples will be collected at visit 2-5. In addition, gastrointestinal symptoms will be recorded at those visits (using Gastrointestinal symptom rating scale-IBS, GSRS-IBS; IBS severity scoring system, IBS- SSS). Quality of life using the 5Q-5D-5L and Hospital Anxiety and Depression Scale (HADS) scores will also be recorded at those visits. In addition, at visit 3 and visit 5, the IBS-Quality of life (IBS-QoL) and the Perceived Stress Scale (PSS) will be completed. In a daily diary, participants will record stool frequency and consistency from visit 2 until end-of-study visit 5. Dietary habits of the patients will be assessed via a food frequency questionnaire (FFQ) and a 3-day food diary before the intervention (between visit 2 and 3).

02

Conditions studied

  • IBS
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 65 is close to the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Örebro University, Sweden is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed informed consent
  • Fulfilled Rome IV diagnostic criteria for IBS with predominant diarrhoea
  • Mild-to-severe IBS symptoms according to the IBS severity scoring system (IBS-SSS; a score of ≥75)
  • Age: 18-65 years

Exclusion criteria

Exclusion Criteria:

  1. Known organic gastrointestinal disease (e.g. inflammatory bowel disease, IBD)
  2. Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
  3. History of or present gastrointestinal malignancy or polyposis
  4. Recently (within the last 6 months) diagnosed gastrointestinal infection
  5. Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
  6. Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
  7. Autoimmune disease and/or patients receiving immunosuppressive medications
  8. Chronic pain syndromes (e.g. fibromyalgia)
  9. Chronic fatigue syndrome
  10. Severe endometriosis
  11. Coeliac disease
  12. Recently (within the last 3 months) diagnosed lactose intolerance
  13. Females who are pregnant or breast-feeding
  14. Regular intake of systemic corticosteroids and anti-inflammatory medication (including non-steroidal anti-inflammatory drugs, NSAIDs) during the last 3 months or incidental use in the last 2 weeks prior to randomisation
  15. Recent (\< 4 weeks) intake of proton pump inhibitors, PPIs (e.g., omeprazol)
  16. Use of anti-depressants in the last 3 months
  17. Regular oral intake of mast cell stabilising drugs (e.g. sodium cromoglycate) during the last 3 months or incidental use in the last 2 weeks prior to screening
  18. Antimicrobial treatment 6 weeks prior to first screening visit
  19. Antimicrobial prophylaxis (eg. acne, urinary tract infection)
  20. Regular consumption of probiotic products 4 weeks prior to first baseline visit
  21. Concurrent or recent (\<4 weeks) use of nutritional supplements or herb products affecting intestinal function (e.g. aloe vera, St. John´s Wort, fibres, prebiotics) if the investigator considers those could affect the study outcome.
  22. Inability to maintain exercise routine and dietary pattern during the study.
  23. Abuse of alcohol or drugs
  24. Any clinically significant present or past disease/condition which in the investigator's opinion could interfere with the results of the trial
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Lactobacillus reuteri strain 1

    Probiotic compound

    Dietary Supplement: Probiotics

  • Experimental
    Lactobacillus reuteri strain 2

    Probiotic compound

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • Dietary supplementProbiotics

    5x10\^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks

  • OtherPlacebo

    Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks

06

What researchers measure

Primary outcomes

  1. Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)

    Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 6-week intervention with the probiotic products compared to the placebo product

    Time frame: 6 weeks

Secondary outcomes

  1. Change in small intestinal permeability after 3 weeks (urinary lactulose/rhamnose ratio, 0-5h)

    Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 3-week intervention with the probiotic products compared to the placebo product

    Time frame: 3 weeks

  2. Change in whole gut permeability after 6 weeks (urinary sucralose/erythritol ratio, 0-24h)

    Difference between intervention with the probiotic products compared to the placebo in whole gut permeability, measured as urinary sucralose/erythritol excretion ratio (0-24hrs)

    Time frame: 6 weeks

  3. Change in whole gut permeability after 3 weeks (urinary sucralose/erythritol excretion ratio, 0-24h)

    Difference between intervention with the probiotic products compared to the placebo in whole gut permeability, measured as urinary sucralose/erythritol excretion ratio (0-24hrs)

    Time frame: 3 weeks

  4. Change in colonic permeability after 6 weeks (urinary sucralose/erythritol ratio, 5-24h)

    Difference between intervention with the probiotic products compared to the placebo in colonic permeability, measured as urinary sucralose/erythritol ratio (5-24hrs)

    Time frame: 6 weeks

  5. Change in colonic permeability after 3 weeks (urinary sucralose/erythritol ratio, 5-24hrs)

    Difference between intervention with the probiotic products compared to the placebo in colonic permeability, measured as urinary sucralose/erythritol ratio (5-24hrs)

    Time frame: 3 weeks

  6. Change in gastroduodenal permeability after 6 weeks (urinary sucrose excretion, 0-5hrs)

    Difference between intervention with the probiotic products compared to the placebo in gastroduodenal permeability, measured as urinary sucrose excretion (0-5hrs)

    Time frame: 6 weeks

  7. Change in gastroduodenal permeability after 3 weeks (urinary sucrose excretion, 0-5hrs)

    Difference between intervention with the probiotic products compared to the placebo in gastroduodenal permeability, measured as urinary sucrose excretion (0-5hrs)

    Time frame: 3 weeks

  8. Change in inflammatory status after 3 weeks

    Difference between intervention with the probiotic products compared to the placebo in inflammatory markers in blood (e.g. high-sensitive C-reactive protein)

    Time frame: 3 weeks

  9. Change in inflammatory status after 6 weeks

    Difference between intervention with the probiotic products compared to the placebo in inflammatory markers in blood (e.g. high-sensitive C-reactive protein)

    Time frame: 6 weeks

Other outcomes

  1. Change in stool frequency and consistency (daily diary on bowel movement using Bristol Stool Chart)

    Difference between intervention with the probiotic products compared to the placebo in stool frequency and consistency

    Time frame: 3 weeks

  2. Change in stool frequency and consistency (daily diary on bowel movement using Bristol Stool Chart)

    Difference between intervention with the probiotic products compared to the placebo in stool frequency and consistency

    Time frame: 6 weeks

  3. Change in gastrointestinal symptoms measured by the IBS-specific gastrointestinal symptom rating scale (GSRS-IBS)

    Difference between intervention with the probiotic products compared to the placebo in gastrointestinal symptoms (GSRS-IBS total score range 0-3, 0-no symptoms, 3-extreme degree of symptoms)

    Time frame: 3 weeks

  4. Change in gastrointestinal symptoms measured by the IBS symptom severity score (IBS-SSS)

    Difference between intervention with the probiotic products compared to the placebo in gastrointestinal symptoms (IBS-SSS, total score range 0-500, 0-no symptoms, 500-extreme degree of symptoms)

    Time frame: 3 weeks

  5. Change in gastrointestinal symptoms measured by the IBS-specific gastrointestinal symptom rating scale (GSRS-IBS)

    Difference between intervention with the probiotic products compared to the placebo in gastrointestinal symptoms (GSRS-IBS total score range 0-3, 0-no symptoms, 3-extreme degree of symptoms)

    Time frame: 6 weeks

  6. Change in gastrointestinal symptoms measured by the IBS symptom severity score (IBS-SSS)

    Difference between intervention with the probiotic products compared to the placebo in gastrointestinal symptoms (IBS-SSS, total score range 0-500, 0-no symptoms, 500-extreme degree of symptoms)

    Time frame: 6 weeks

  7. Change in quality of life measured by IBS-specific quality of life (IBS-QOL) questionnaire

    Difference between intervention with the probiotic products compared to the placebo in quality of life (IBS-QOL total range, range: 0-100, 0-low quality of life, 100-high quality of life)

    Time frame: 3 weeks

  8. Change in quality of life measured by IBS-specific quality of life (IBS-QOL) questionnaire

    Difference between intervention with the probiotic products compared to the placebo in quality of life IBS-QOL total range, range: 0-100, 0-low quality of life, 100-high quality of life)

    Time frame: 6 weeks

  9. Change in perceived stress using the perceived stress scale (PSS)

    Difference between intervention with the probiotic products compared to the placebo in perceived stress (PSS range 0-40: 0-no stress, 40-high stress)

    Time frame: 3 weeks

  10. Change in perceived stress using the perceived stress scale (PSS)

    Difference between intervention with the probiotic products compared to the placebo in perceived stress (PSS range 0-40: 0-no stress, 40-high stress)

    Time frame: 6 weeks

  11. Change in anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS)

    Difference between intervention with the probiotic products compared to the placebo in anxiety and depression symptoms (HADS range: 0 to 21 for anxiety and 0 to 21 for depression, 0-low levels, 21 high levels)

    Time frame: 3 weeks

  12. Change in anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS)

    Difference between intervention with the probiotic products compared to the placebo in anxiety and depression symptoms (HADS range: 0 to 21 for anxiety and 0 to 21 for depression, 0-low levels, 21 high levels)

    Time frame: 6 weeks

  13. Change in salivary cortisol levels

    Difference between intervention with the probiotic products compared to the placebo in salivary cortisol levels

    Time frame: 3 weeks

  14. Change in salivary cortisol levels

    Difference between intervention with the probiotic products compared to the placebo in salivary cortisol levels

    Time frame: 6 weeks

  15. Change in intestinal microbiota composition (16S rRNA-based next generation sequencing of faecal samples) after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in intestinal microbiota composition

    Time frame: 3 weeks

  16. Change in intestinal microbiota composition (16S rRNA-based next generation sequencing of faecal samples) after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in intestinal microbiota composition

    Time frame: 6 weeks

  17. Change in metabolomic profile in faecal samples after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in metabolomic profile in faecal samples

    Time frame: 3 weeks

  18. Change in metabolomic profile in faecal samples after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in metabolomic profile in faecal samples

    Time frame: 6 weeks

  19. Change in metabolomic profile in blood samples after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in metabolomic profile in faecal samples

    Time frame: 3 weeks

  20. Change in metabolomic profile in blood samples after probiotic intervention

    Difference between intervention with the probiotic products compared to the placebo in metabolomic profile in faecal samples

    Time frame: 6 weeks

07

Study locations

1 site
  • Örebro University
    Örebro, Örebro Län 70182, Sweden
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared, only data on group level will

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03986476
Lead sponsor
Örebro University, Sweden
Responsible party
Robert Brummer (Professor, MD, PhD, Örebro University, Sweden) — Principal investigator
First posted
Jun 14, 2019
Start date
Mar 26, 2019
Primary completion
May 10, 2021
Completion
May 10, 2021
Last update
Sep 9, 2021

Study contacts

Robert J Brummer, MD, PhD
principal investigator · Örebro University, Sweden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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