Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.

Official Title
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Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).

Conditions
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Irritable Bowel Syndrome, IBS

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium longum
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria Symptoms of mild to moderate anxiety and depression Exclusion Criteria: Concurrent systemic disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection. Concurrent organic Gastrointestinal (GI) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli. Psychiatric diagnosis other than anxiety or depression. Patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics History of active cancer in the last 5 years, other than skin basal cells cancer Pregnant or breastfeeding women Treatment with antibiotics during the three months prior the study. Known or suspected allergies to the study products (eg maltodextrin). Patients who have heart pacemakers, metal implants, metal chips or clips in or around the eyeballs, artificial heart valves, metallic ear implants, bullet fragments or fixed brackets. High fiber diet (>35 g/day for males, > 25 g/day for females), consumption of high inulin containing foods (>5 g/day). Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the beginning of the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium longum<br> | Dietary Supplement: Bifidobacterium longum<br>* Powder containing Bifidobacterium longum in maltodextrin.<br>|
| Placebo Comparator: Maltodextrin<br> | Other: Maltodextrin<br>* Powder containing only maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression (HAD) scale. | Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment. | 6 weeks post-treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in IBS symptoms. |  | 6 and 10 weeks post-treatment | 
| Improvement in objective biomarkers. |  | 6 weeks post-treatment |