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Probiotics in the Treatment of Irritable Bowel Syndrome

NCT ID: NCT02953171

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Keywords

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Irritable Bowel Syndrome The human microbiome Microbiota Gut microbiota Probiotics Sauerkraut

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Raw sauerkraut+Probiotic capsule

75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

Group Type EXPERIMENTAL

Raw, lacto-fermented sauerkraut

Intervention Type 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.

Mutaflor

Intervention Type DIETARY_SUPPLEMENT

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

Raw sauerkraut+placebo capsule

75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.

Group Type EXPERIMENTAL

Raw, lacto-fermented sauerkraut

Intervention Type 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.

Placebo capsule

Intervention Type OTHER

Capsules without probiotics

Pasteurized sauerkraut+Probiotic capsule

75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

Group Type EXPERIMENTAL

Mutaflor

Intervention Type DIETARY_SUPPLEMENT

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

Pasteurized sauerkraut

Intervention Type OTHER

Sauerkraut without live bacteria.

Pasteurized sauerkraut+Placebo capsule

75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.

Group Type PLACEBO_COMPARATOR

Pasteurized sauerkraut

Intervention Type OTHER

Sauerkraut without live bacteria.

Placebo capsule

Intervention Type OTHER

Capsules without probiotics

Interventions

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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.

Intervention Type OTHER

Mutaflor

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

Intervention Type DIETARY_SUPPLEMENT

Pasteurized sauerkraut

Sauerkraut without live bacteria.

Intervention Type OTHER

Placebo capsule

Capsules without probiotics

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Eirik Garnås

Public Health Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Volvat Medisinske Senter, Majorstuen

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Eirik Garnås

Role: CONTACT

Phone: 45293161

Email: [email protected]

Facility Contacts

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Peder Sandvold Olsen, MD

Role: primary

Other Identifiers

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2016/1129/REK

Identifier Type: -

Identifier Source: org_study_id