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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01276626

Enrollment

Registered

2011-01-13

Start date

2011-01-31

Completion date

2014-06-30

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, IBS

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.

Interventions

DIETARY_SUPPLEMENTBifidobacterium longum

Powder containing Bifidobacterium longum in maltodextrin.

OTHERMaltodextrin

Powder containing only maltodextrin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Improvement in IBS symptoms.	6 and 10 weeks post-treatment
Improvement in objective biomarkers.	6 weeks post-treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026