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Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eirik Garnås, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT02977975
First received: November 26, 2016
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.

Condition Intervention
Irritable Bowel Syndrome
Other: Raw sauerkraut
Other: Pasteurized sauerkraut

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Copenhagen:

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

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

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

Enrollment: 70
Study Start Date: September 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02977975

Locations
Norway
Volvat Medisinske Senter, Majorstuen
Oslo, Norway, 0370
Sponsors and Collaborators
University of Copenhagen
  More Information

Responsible Party: Eirik Garnås, Public Health Nutritionist, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02977975     History of Changes
Other Study ID Numbers: 2016/1130/REK
Study First Received: November 26, 2016
Last Updated: February 17, 2017

Keywords provided by University of Copenhagen:
Irritable bowel syndrome
The human microbiome
Microbiota
Gut microbiota
Probiotics
Sauerkraut

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 28, 2017