IBSNCT03986476
The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome
A study testing Probiotics in people with IBS, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- 26 Mar 2019to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known organic gastrointestinal disease (e.g. inflammatory bowel disease, IBD)
- Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
- History of or present gastrointestinal malignancy or polyposis
- Recently (within the last 6 months) diagnosed gastrointestinal infection
- Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
Show all 24Show fewer
- Autoimmune disease and/or patients receiving immunosuppressive medications
- Chronic pain syndromes (e.g. fibromyalgia)
- Chronic fatigue syndrome
- Severe endometriosis
- Coeliac disease
- Recently (within the last 3 months) diagnosed lactose intolerance
- Females who are pregnant or breast-feeding
- 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
- Recent (< 4 weeks) intake of proton pump inhibitors, PPIs (e.g., omeprazol)
- Use of anti-depressants in the last 3 months
- 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
- Antimicrobial treatment 6 weeks prior to first screening visit
- Antimicrobial prophylaxis (eg. acne, urinary tract infection)
- Regular consumption of probiotic products 4 weeks prior to first baseline visit
- 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.
- Inability to maintain exercise routine and dietary pattern during the study.
- Abuse of alcohol or drugs
- Any clinically significant present or past disease/condition which in the investigator's opinion could interfere with the results of the trial
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- IBS
- Being tested
- Probiotics, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
5x10^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks
PlaceboOther
Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri strain 1 | Experimental | Probiotic compound Receives: Dietary Supplement: Probiotics |
| Lactobacillus reuteri strain 2 | Experimental | Probiotic compound Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (9)
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
Measured: 3 weeks
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)
Measured: 6 weeks
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)
Measured: 3 weeks
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)
Measured: 6 weeks
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)
Measured: 3 weeks
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)
Measured: 6 weeks
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)
Measured: 3 weeks
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)
Measured: 3 weeks
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start26 Mar 2019
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBSStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, MD, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986476
- Sponsor's protocol ID
- 2018/450
- Status last verified
- Sep 2021
- First submitted
- 7 Jun 2019
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared, only data on group level will
Publications
Konig J, Roca Rubio MF, Forsgard RA, Rode J, Axelsson J, Grompone G, Brummer RJ. The effects of a 6-week intervention with Limosilactobacillus reuteri ATCC PTA 6475 alone and in combination with L. reuteri DSM 17938 on gut barrier function, immune markers, and symptoms in patients with IBS-D-An exploratory RCT. PLoS One. 2024 Nov 1;19(11):e0312464. doi: 10.1371/journal.pone.0312464. eCollection 2024.
PubMed 39485760
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03986476
- Acronym / sponsor ID
- 2018/450
- Conditions
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 14 Jun 2019 (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.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri strain 1 | Experimental | Dietary Supplement: ProbioticsProbiotic compound |
| Lactobacillus reuteri strain 2 | Experimental | Dietary Supplement: ProbioticsProbiotic compound |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- Known organic gastrointestinal disease (e.g. inflammatory bowel disease, IBD)
- Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
- History of or present gastrointestinal malignancy or polyposis
- Recently (within the last 6 months) diagnosed gastrointestinal infection
- Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
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 |
|---|---|---|
| Probiotics5x10^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks | Dietary supplement | Lactobacillus reuteri strain 1, Lactobacillus reuteri strain 2 |
| PlaceboSimilar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks | Other | Placebo |
Primary outcome
Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)
Time frame: 6 weeks
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
9 secondary outcomes
Change in small intestinal permeability after 3 weeks (urinary lactulose/rhamnose ratio, 0-5h)
Time frame: 3 weeks
Change in whole gut permeability after 6 weeks (urinary sucralose/erythritol ratio, 0-24h)
Time frame: 6 weeks
Change in whole gut permeability after 3 weeks (urinary sucralose/erythritol excretion ratio, 0-24h)
Time frame: 3 weeks
Change in colonic permeability after 6 weeks (urinary sucralose/erythritol ratio, 5-24h)
Time frame: 6 weeks
Change in colonic permeability after 3 weeks (urinary sucralose/erythritol ratio, 5-24hrs)
Time frame: 3 weeks
Change in gastroduodenal permeability after 6 weeks (urinary sucrose excretion, 0-5hrs)
Time frame: 6 weeks
Change in gastroduodenal permeability after 3 weeks (urinary sucrose excretion, 0-5hrs)
Time frame: 3 weeks
Change in inflammatory status after 3 weeks
Time frame: 3 weeks
Change in inflammatory status after 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 39485760Konig J, Roca Rubio MF, Forsgard RA, Rode J, Axelsson J, Grompone G, Brummer RJ. The effects of a 6-week intervention with Limosilactobacillus reuteri ATCC PTA 6475 alone and in combination with L. reuteri DSM 17938 on gut barrier function, immune markers, and symptoms in patients with IBS-D-An exploratory RCT. PLoS One. 2024 Nov 1;19(11):e0312464. doi: 10.1371/journal.pone.0312464. eCollection 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared, only data on group level will
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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. This study is not recruiting at the moment.
Robert J Brummer, MD, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with IBS, run by Örebro University, Sweden 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 4 inclusion and 24 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: finished, as of the sponsor's last update on 9 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986476, which also lists 1 linked publication.
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 9 Sep 2021.