NCT01276626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

3.4 years

First QC Date

December 27, 2010

Last Update Submit

August 4, 2014

Conditions

Irritable Bowel SyndromeIBS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Improvement in IBS symptoms.

    6 and 10 weeks post-treatment

  • Improvement in objective biomarkers.

    6 weeks post-treatment

Study Arms (2)

Bifidobacterium longum

EXPERIMENTAL
Dietary Supplement: Bifidobacterium longum

Maltodextrin

PLACEBO COMPARATOR
Other: Maltodextrin

Interventions

Bifidobacterium longumDIETARY_SUPPLEMENT

Powder containing Bifidobacterium longum in maltodextrin.

Bifidobacterium longum
MaltodextrinOTHER

Powder containing only maltodextrin

Maltodextrin

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria
  • Symptoms of mild to moderate anxiety and depression

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28483500DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Peter McLean, PhD

    Société des Produits Nestlé (SPN)

    STUDY DIRECTOR

  • Premysl Bercik, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2010

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

CA(1)