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NCT Number: NCT01276626

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases IBS Intestinal Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifidobacterium longum

Dietary Supplement

Powder containing Bifidobacterium longum in maltodextrin.

maltodextrin

Other

Powder containing only maltodextrin

Primary outcomes

  1. Hospital Anxiety and Depression (HAD) scale.

    Time frame: 6 weeks post-treatment initiation

    Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.

Secondary outcomes

  1. Improvement in IBS symptoms.

    Time frame: 6 and 10 weeks post-treatment

  2. Improvement in objective biomarkers.

    Time frame: 6 weeks post-treatment

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2011
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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