NCT01276626CompletedPhase 1
Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
Société des Produits Nestlé (SPN)2 sites in 1 country40 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Hospital Anxiety and Depression (HAD) scale.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Improvement in IBS symptoms.(6 and 10 weeks post-treatment)
- Improvement in objective biomarkers.(6 weeks post-treatment)
Investigators
Study Sites (2)
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