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

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT01276626

Collaborator

McMaster University (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hospital Anxiety and Depression (HAD) scale. [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

Improvement in IBS symptoms. [6 and 10 weeks post-treatment]
Improvement in objective biomarkers. [6 weeks post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT01276626

Other Study ID Numbers:

Nestle 09.25.NRC

First Posted:

Jan 13, 2011

Last Update Posted:

Aug 5, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of Aug 5, 2014