Irritable Bowel SyndromeNCT02953171
Probiotics in the Treatment of Irritable Bowel Syndrome
A study testing Raw, lacto-fermented sauerkraut, Mutaflor and Pasteurized sauerkraut in people with Irritable Bowel Syndrome, run by University of Copenhagen at 1 site in Norway.
Trial summary
The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Raw, lacto-fermented sauerkraut, Mutaflor and Pasteurized sauerkraut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to Jul 2017
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis):
- Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
Who cannot join
- Psychiatric disorder
- Metabolic disease
- Chronic infection
- Organic gastrointestinal disorder
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Volvat Medisinske Senter, Majorstuen
Oslo, Oslo, 0370
Peder Sandvold Olsen, MD, studie.ibs@gmail.com
About this study
Official title: A Randomized Controlled Clinical Trial to Investigate the Efficacy of Lacto-fermented Sauerkraut and the Probiotic E. Coli Nissle 1917 in the Treatment of Irritable Bowel Syndrome
The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet. More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.
Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent.
Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Raw, lacto-fermented sauerkraut, Mutaflor, Pasteurized sauerkraut, Placebo capsule
- Keywords
- Irritable Bowel Syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw, lacto-fermented sauerkrautOther
Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.
MutaflorDietary supplement
The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.
Pasteurized sauerkrautOther
Sauerkraut without live bacteria.
Placebo capsuleOther
Capsules without probiotics
| Study group | Role | What they receive |
|---|---|---|
| Raw sauerkraut+Probiotic capsule | Experimental | 75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks. Receives: Other: Raw, lacto-fermented sauerkraut; Dietary Supplement: Mutaflor |
| Raw sauerkraut+placebo capsule | Experimental | 75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks. Receives: Other: Raw, lacto-fermented sauerkraut; Other: Placebo capsule |
| Pasteurized sauerkraut+Probiotic capsule | Experimental | 75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks. Receives: Dietary Supplement: Mutaflor; Other: Pasteurized sauerkraut |
| Pasteurized sauerkraut+Placebo capsule | Placebo comparator | 75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks. Receives: Other: Pasteurized sauerkraut; Other: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Symptom Severity Scale (IBS-SSS).
Measured: Change from day 0 to day 42
Secondary outcomes (3)
Body weight
Measured: Change from day 0 to day 42
Fecal microbiome diversity
16S rRNA gene sequences (prokaryotes)
Measured: Change from day 0 to day 42
The Quality of Life Scale (QOLS)
Measured: Change from day 0 to day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eirik Garnås, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953171
- Sponsor's protocol ID
- 2016/1129/REK
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Investigate the Efficacy of Lacto-fermented Sauerkraut and the Probiotic E. Coli Nissle 1917 in the Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02953171
- Acronym / sponsor ID
- 2016/1129/REK
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- 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.
The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.
Detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet. More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.
Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent.
Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Raw sauerkraut+Probiotic capsule | Experimental | Other: Raw, lacto-fermented sauerkraut, Dietary Supplement: Mutaflor75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks. |
| Raw sauerkraut+placebo capsule | Experimental | Other: Raw, lacto-fermented sauerkraut, Other: Placebo capsule75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks. |
| Pasteurized sauerkraut+Probiotic capsule | Experimental | Dietary Supplement: Mutaflor, Other: Pasteurized sauerkraut75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks. |
| Pasteurized sauerkraut+Placebo capsule | Placebo comparator | Other: Pasteurized sauerkraut, Other: Placebo capsule75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis):
- Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
Key exclusion criteria (6 listed)
- Psychiatric disorder
- Metabolic disease
- Chronic infection
- Organic gastrointestinal disorder
- Pregnancy
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 |
|---|---|---|
| Raw, lacto-fermented sauerkrautSauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics. | Other | Raw sauerkraut+Probiotic capsule, Raw sauerkraut+placebo capsule |
| MutaflorThe probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors. | Dietary supplement | Pasteurized sauerkraut+Probiotic capsule, Raw sauerkraut+Probiotic capsule |
| Pasteurized sauerkrautSauerkraut without live bacteria. | Other | Pasteurized sauerkraut+Placebo capsule, Pasteurized sauerkraut+Probiotic capsule |
| Placebo capsuleCapsules without probiotics | Other | Pasteurized sauerkraut+Placebo capsule, Raw sauerkraut+placebo capsule |
Primary outcome
IBS Symptom Severity Scale (IBS-SSS).
Time frame: Change from day 0 to day 42
3 secondary outcomes
Body weight
Time frame: Change from day 0 to day 42
Fecal microbiome diversity
Time frame: Change from day 0 to day 42
The Quality of Life Scale (QOLS)
Time frame: Change from day 0 to day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raw, lacto-fermented sauerkraut, Mutaflor and Pasteurized sauerkraut in people with Irritable Bowel Syndrome, run by University of Copenhagen at 1 site in Norway.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eirik Garnås (45293161 ext. 0047, dzs565@alumni.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS Symptom Severity Scale (IBS-SSS). (time frame: Change from day 0 to day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.