Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome
This study is currently recruiting participants.
Verified April 2013 by Nestlé
Sponsor:
Nestlé
Collaborator:
McMaster University
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01276626
First received: December 27, 2010
Last updated: April 17, 2013
Last verified: April 2013
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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). |
Resource links provided by NLM:
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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276626
Contacts
| Contact: Mirna Del Valle | 973-593-7749 | mirna.delvalle@rd.nestle.com |
Locations
| Canada, Ontario | |
| McMaster University Medical Center | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Premysl Bercik, MD 1-905-521-2100 ext 73495 bercikp@mcmaster.ca | |
| Contact: M. Ines Pinto, MD 1-905-525-8962 ext 21955 pintosm@mcmaster.ca | |
| Principal Investigator: Premysl Bercik, MD | |
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: | April 17, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Sulfalene Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 16, 2013