Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Raw sauerkraut
Pasteurized sauerkraut
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- Psychiatric disorder
- Metabolic disease
- Chronic infection
- Organic gastrointestinal disorder
- Pregnancy
- Breastfeeding
Sites / Locations
- Volvat Medisinske Senter, Majorstuen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Raw sauerkraut
Pasteurized sauerkraut
Arm Description
75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
75 grams of pasteurized sauerkraut, each day for 6 weeks.
Outcomes
Primary Outcome Measures
IBS Symptom Severity Scale (IBS-SSS).
Secondary Outcome Measures
Body weight
Fecal microbiome diversity
16S rRNA gene sequences (prokaryotes)
The Quality of Life Scale (QOLS)
Full Information
NCT ID
NCT02977975
First Posted
November 26, 2016
Last Updated
December 18, 2017
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02977975
Brief Title
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Official Title
A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut 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.
Several studies have shown that an altered gut microbiota profile is present in at least some subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have elevated levels of inflammatory mediators in systemic circulation.
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.
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 such as Lactobacillus plantarum, are useful in the treatment of IBS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raw sauerkraut
Arm Type
Experimental
Arm Description
75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
Arm Title
Pasteurized sauerkraut
Arm Type
Other
Arm Description
75 grams of pasteurized sauerkraut, each day for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Raw sauerkraut
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pasteurized sauerkraut
Intervention Description
Sauerkraut without live bacteria.
Primary Outcome Measure Information:
Title
IBS Symptom Severity Scale (IBS-SSS).
Time Frame
Change from day 0 to day 42
Secondary Outcome Measure Information:
Title
Body weight
Time Frame
Change from day 0 to day 42
Title
Fecal microbiome diversity
Description
16S rRNA gene sequences (prokaryotes)
Time Frame
Change from day 0 to day 42
Title
The Quality of Life Scale (QOLS)
Time Frame
Change from day 0 to day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Psychiatric disorder
Metabolic disease
Chronic infection
Organic gastrointestinal disorder
Pregnancy
Breastfeeding
Facility Information:
Facility Name
Volvat Medisinske Senter, Majorstuen
City
Oslo
ZIP/Postal Code
0370
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
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