Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Pasteurized sauerkraut; Other: Raw sauerkraut

• Registration Number: NCT02977975
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-26
• Study First Submitted QC: 2016-11-26
• Study First Posted: 2016-11-30
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pasteurized sauerkraut	Pasteurized sauerkraut	75 grams of pasteurized sauerkraut, each day for 6 weeks.
Raw sauerkraut	Raw sauerkraut	75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.

Primary Outcome Measures

Name	Time	Method
IBS Symptom Severity Scale (IBS-SSS).	Change from day 0 to day 42

Secondary Outcome Measures

Name	Time	Method
Body weight	Change from day 0 to day 42
Fecal microbiome diversity	Change from day 0 to day 42	16S rRNA gene sequences (prokaryotes)
The Quality of Life Scale (QOLS)	Change from day 0 to day 42

Trial Locations

Locations (1)

Volvat Medisinske Senter, Majorstuen; 🇳🇴 Oslo, Norway