Probiotics in the Treatment of Irritable Bowel Syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Mutaflor; Other: Pasteurized sauerkraut; Other: Raw, lacto-fermented sauerkraut; Other: Placebo capsule

• Registration Number: NCT02953171
• Lead Sponsor: University of Copenhagen

Brief 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.

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 Timeline

• Study Start: 2016-09
• Status Verified: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-02
• Last Update Posted: 2016-11-02
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pasteurized sauerkraut+Placebo capsule	Placebo capsule	75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.
Pasteurized sauerkraut+Probiotic capsule	Mutaflor	75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
Pasteurized sauerkraut+Placebo capsule	Pasteurized sauerkraut	75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.
Raw sauerkraut+placebo capsule	Raw, lacto-fermented sauerkraut	75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.
Pasteurized sauerkraut+Probiotic capsule	Pasteurized sauerkraut	75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
Raw sauerkraut+Probiotic capsule	Raw, lacto-fermented sauerkraut	75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
Raw sauerkraut+placebo capsule	Placebo capsule	75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.
Raw sauerkraut+Probiotic capsule	Mutaflor	75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, 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
The Quality of Life Scale (QOLS)	Change from day 0 to day 42
Fecal microbiome diversity	Change from day 0 to day 42	16S rRNA gene sequences (prokaryotes)
Body weight	Change from day 0 to day 42

Trial Locations

Locations (1)

Volvat Medisinske Senter, Majorstuen; 🇳🇴 Oslo, Norway