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Completed

NCT Number: NCT02977975

Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

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

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Volvat Medisinske Senter, Majorstuen

Oslo, 0370, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raw sauerkraut

Other

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

Other

Sauerkraut without live bacteria.

Primary outcomes

  1. IBS Symptom Severity Scale (IBS-SSS).

    Time frame: Change from day 0 to day 42

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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