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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276626
• Other study ID #: Nestle 09.25.NRC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 27, 2010
• Last updated: August 4, 2014
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• IBS
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Bifidobacterium longum
Powder containing Bifidobacterium longum in maltodextrin.

Other:
• Maltodextrin
Powder containing only maltodextrin

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in IBS symptoms.		6 and 10 weeks post-treatment	No
Secondary	Improvement in objective biomarkers.		6 weeks post-treatment	No