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

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01276626
First received: December 27, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
IBS
Dietary Supplement: Bifidobacterium longum
Other: Maltodextrin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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).

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Hospital Anxiety and Depression (HAD) scale. [ Time Frame: 6 weeks post-treatment initiation ] [ Designated as safety issue: No ]
    Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.


Secondary Outcome Measures:
  • Improvement in IBS symptoms. [ Time Frame: 6 and 10 weeks post-treatment ] [ Designated as safety issue: No ]
  • Improvement in objective biomarkers. [ Time Frame: 6 weeks post-treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bifidobacterium longum Dietary Supplement: Bifidobacterium longum
Powder containing Bifidobacterium longum in maltodextrin.
Placebo Comparator: Maltodextrin Other: Maltodextrin
Powder containing only maltodextrin

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276626

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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01276626     History of Changes
Other Study ID Numbers: Nestle 09.25.NRC
Study First Received: December 27, 2010
Last Updated: August 4, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014