Probiotics in the Treatment of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomized Controlled Clinical Trial to Investigate the Efficacy of Lacto-fermented Sauerkraut and the Probiotic E. Coli Nissle 1917 in the Treatment of Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02953171
• Other study ID #: 2016/1129/REK
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2016
• Last updated: October 31, 2016
• Start date: September 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2016
• Source: University of Copenhagen
• Contact: Eirik Garnås
• Phone: 45293161
• Email: dzs565[@]alumni.ku.dk
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.

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.

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. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent.

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, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Raw, lacto-fermented 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.

Dietary Supplement:
• Mutaflor
The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.

Other:
• Pasteurized sauerkraut
Sauerkraut without live bacteria.
• Placebo capsule
Capsules without probiotics

Locations

Country	Name	City	State
Norway	Volvat Medisinske Senter, Majorstuen	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS Symptom Severity Scale (IBS-SSS).		Change from day 0 to day 42	No
Secondary	Body weight		Change from day 0 to day 42	No
Secondary	Fecal microbiome diversity	16S rRNA gene sequences (prokaryotes)	Change from day 0 to day 42	No
Secondary	The Quality of Life Scale (QOLS)		Change from day 0 to day 42	No