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Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02977975
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):
Eirik Garnås, University of Copenhagen

Brief Summary:
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Raw sauerkraut Other: Pasteurized sauerkraut Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Study Start Date : September 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Raw sauerkraut
75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
Other: Raw sauerkraut
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.

Pasteurized sauerkraut
75 grams of pasteurized sauerkraut, each day for 6 weeks.
Other: Pasteurized sauerkraut
Sauerkraut without live bacteria.

Primary Outcome Measures :
  1. IBS Symptom Severity Scale (IBS-SSS). [ Time Frame: Change from day 0 to day 42 ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: Change from day 0 to day 42 ]
  2. Fecal microbiome diversity [ Time Frame: Change from day 0 to day 42 ]
    16S rRNA gene sequences (prokaryotes)

  3. The Quality of Life Scale (QOLS) [ Time Frame: Change from day 0 to day 42 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Improvement with defecation
  2. Onset associated with a change in frequency of stool
  3. Onset associated with a change in form (appearance) of stool

Exclusion Criteria:

  • Psychiatric disorder
  • Metabolic disease
  • Chronic infection
  • Organic gastrointestinal disorder
  • Pregnancy
  • Breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02977975

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Volvat Medisinske Senter, Majorstuen
Oslo, Norway, 0370
Sponsors and Collaborators
University of Copenhagen
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Responsible Party: Eirik Garnås, Public Health Nutritionist, University of Copenhagen Identifier: NCT02977975    
Other Study ID Numbers: 2016/1130/REK
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Keywords provided by Eirik Garnås, University of Copenhagen:
Irritable bowel syndrome
The human microbiome
Gut microbiota
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases