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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276626
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : August 5, 2014
McMaster University
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome IBS Dietary Supplement: Bifidobacterium longum Other: Maltodextrin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
Study Start Date : January 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Bifidobacterium longum Dietary Supplement: Bifidobacterium longum
Powder containing Bifidobacterium longum in maltodextrin.

Placebo Comparator: Maltodextrin Other: Maltodextrin
Powder containing only maltodextrin

Primary Outcome Measures :
  1. Hospital Anxiety and Depression (HAD) scale. [ Time Frame: 6 weeks post-treatment initiation ]
    Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.

Secondary Outcome Measures :
  1. Improvement in IBS symptoms. [ Time Frame: 6 and 10 weeks post-treatment ]
  2. Improvement in objective biomarkers. [ Time Frame: 6 weeks post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276626

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Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
McMaster University
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Study Director: Peter McLean, PhD Nestlé
Principal Investigator: Premysl Bercik, MD McMaster University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nestlé Identifier: NCT01276626     History of Changes
Other Study ID Numbers: Nestle 09.25.NRC
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents