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

Primary Purpose

Irritable Bowel Syndrome, IBS

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Bifidobacterium longum
Maltodextrin
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • McMaster University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bifidobacterium longum

Maltodextrin

Arm Description

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression (HAD) scale.
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.
Improvement in objective biomarkers.

Full Information

First Posted
December 27, 2010
Last Updated
August 4, 2014
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01276626
Brief Title
Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome
Official Title
Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bifidobacterium longum
Arm Type
Experimental
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium longum
Intervention Description
Powder containing Bifidobacterium longum in maltodextrin.
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Powder containing only maltodextrin
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression (HAD) scale.
Description
Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.
Time Frame
6 weeks post-treatment initiation
Secondary Outcome Measure Information:
Title
Improvement in IBS symptoms.
Time Frame
6 and 10 weeks post-treatment
Title
Improvement in objective biomarkers.
Time Frame
6 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McLean, PhD
Organizational Affiliation
Société des Produits Nestlé (SPN)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Premysl Bercik, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28483500
Citation
Pinto-Sanchez MI, Hall GB, Ghajar K, Nardelli A, Bolino C, Lau JT, Martin FP, Cominetti O, Welsh C, Rieder A, Traynor J, Gregory C, De Palma G, Pigrau M, Ford AC, Macri J, Berger B, Bergonzelli G, Surette MG, Collins SM, Moayyedi P, Bercik P. Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome. Gastroenterology. 2017 Aug;153(2):448-459.e8. doi: 10.1053/j.gastro.2017.05.003. Epub 2017 May 5.
Results Reference
derived

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

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