Probiotics in the Treatment of Irritable Bowel Syndrome

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

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.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Raw, lacto-fermented sauerkraut; Dietary supplement: Mutaflor; Other: Placebo capsule; Other: Pasteurized sauerkraut

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eirik Garnås; Phone Number: 0047 45293161; Email: dzs565@alumni.ku.dk

Study Locations

• Norway
  • Oslo, Norway, 0370
    • Recruiting
    • Volvat Medisinske Senter, Majorstuen
    • Contact: Peder Sandvold Olsen, MD; Email: studie.ibs@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raw sauerkraut+Probiotic capsule; 75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.	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.
Experimental: Raw sauerkraut+placebo capsule; 75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.	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.; Other: Placebo capsule; Capsules without probiotics
Experimental: Pasteurized sauerkraut+Probiotic capsule; 75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.	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 Comparator: Pasteurized sauerkraut+Placebo capsule; 75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.	Other: Placebo capsule; Capsules without probiotics; Other: Pasteurized sauerkraut; Sauerkraut without live bacteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IBS Symptom Severity Scale (IBS-SSS).	Change from day 0 to day 42

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Microbiota; Probiotics; The human microbiome; Gut microbiota; Sauerkraut
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 2016/1129/REK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No