Plain English Summary
Background and study aims:
Probiotics are microorganisms, characterised by their ability to survive the passage through the gut. They are often found in milk products such as yogurt and also commonly used as food supplements. Regular consumption is believed to have a beneficial effect on the abdominal wellbeing and bowel habit. The aim in this study is to investigate whether a capsule with a specific probiotic microorganism can improve the general abdominal wellbeing more than a capsule that does not contain probiotics.
Who can participate?
Individuals aged 18–70 years who are have good general health but with some gastrointestinal complaints and a low defecation frequency.
What does the study involve?
Participants will be randomly allocated to one of three groups and must take the study product every day for 4 weeks. The study product is a capsule containing probiotics (high or low dose) or no probiotics (placebo). Participants will need to complete a diary in which they must record information about their bowel habits and discomfort for each day. Additionally, all study participants should complete questionnaires about physical activity, general quality of life and food habits twice during the study.
What are the possible benefits and risks of participating?
The consumption of the probiotic capsule could lead to a general improvement in the subject’s gastrointestinal wellbeing and bowel habit. There are no known risks to participants taking part in this study.
Where is the study run from?
Clinical research centres: EUROFINS OPTIMED (France), OPTIMED (France), CRS Clinical Research Services Mannheim GmbH (Germany), CRS Clinical Research Services Mönchengladbach GmbH (Germany), CRS Clinical Research Services Kiel GmbH (Germany), Analyze & Realize AG (Germany), Leatherhead Food Research (UK) and SynteractHCR (Germany)
When is the study starting and how long is it expected to run for?
September 2010 to December 2012.
Who is funding the study?
Chr Hansen A/S (Denmark)
Who is the main contact?
Mrs Lillian Jespersen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HND-GI-004
Study information
Scientific title
The efficacy of 4 weeks supplementation with Bifidobacterium animalis subsp. lactis, BB-12® in a capsule on overall gastrointestinal well-being, stool frequency and gastrointestinal discomfort
symptoms in healthy men and women with abdominal discomfort – a randomized, double-blind, placebo-controlled, parallel group study
Acronym
Study hypothesis
To investigate the efficacy of daily consumption of the probiotic strain BB-12® for 4 weeks on the overall gastrointestinal wellbeing, stool frequency and gastrointestinal discomfort symptoms in healthy individuals with gastrointestinal discomfort
Ethics approval
1. Comité de Protection des Personnes Sud-Est IV (France), 16/09/2010, ref: 2010-A00958-31
2. Ethikkommission Schleswig-Holstein (Germany), 31/10/2011, ref: 155/11 (m)
3. Ethik-Kommission bei der Landesärztekammer Baden-Württemberg (Germany), 15/11/2011, ref: B-F-2011-076
4. Ethik-Kommission bei der Ärztekammer Nordrhein (Germany), 30/11/2011, ref: 2011405
5. Ethik kommission der Charité (Germany), 20/10/2011, ref: EA1/236/11
6. National Research Ethics Service Committee London (UK), 24/08/2011, ref: 11/LO/1246
7. Ethikkommission der Bayerischen Landesärztekammer (Germany), 24/09/2012, ref: mb BO 12044
Study design
Randomised double-blind placebo-controlled multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Low defecation frequency and abdominal discomfort
Intervention
Study products to be taken orally once daily for 4 weeks:
1. Capsule containing a high dose (10 billion colony-forming units [CFU]) of BB-12®
2. Capsule containing a low dose (1 billion CFU) of BB-12®
3. Placebo capsule with no probiotics
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Stool frequency will be measured with a completed Bristol Stool Form at baseline and each week during the intervention period
2. General abdominal discomfort will be measured each week during the intervention period by subject’s rating of general abdominal discomfort compared with before the study (markedly relieved, somewhat relieved, unchanged, somewhat worsened and markedly worsened)
Secondary outcome measures
Abdominal discomfort symptoms will be rated daily during the entire study with a Likert scale (0=no, 1=mild, 2=moderate, 3=severe and 4=unbearable) and results averaged for baseline and each week during the intervention period
Overall trial start date
01/06/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy
2. Age 18–70 years
3. Body-mass index 19–35 kg/m2
4. General abdominal discomfort or complaints
5. A low defecation frequency
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
1740
Participant exclusion criteria
1. History of hypersensitivity to any of the ingredients of the study products
2. History of lactose intolerance
3. History or diagnosis of gastrointestinal disease, irritable bowel syndrome or complicated gastrointestinal surgery
4. Depressive disorder
5. Any physical abnormality or medical condition that could have an effect on gastrointestinal discomfort
6. Participation in any other clinical study
7. Not willing or able to provide written informed consent for participation in the study or for transmission of personal pseudonymised data
8. Women not willing or able to use a reliable contraceptive method
9. Pregnancy
10. Lactation
11. Wish to become pregnant
Recruitment start date
01/09/2010
Recruitment end date
01/11/2012
Locations
Countries of recruitment
France, Germany, United Kingdom
Trial participating centre
EUROFINS OPTIMED
Gieres
38610
France
Trial participating centre
OPTIMED
Lyon
69310
France
Trial participating centre
CRS Clinical Research Services Mannheim GmbH
Mannheim
68167
Germany
Trial participating centre
CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach
41061
Germany
Trial participating centre
CRS Clinical Research Services Kiel GmbH
Kiel
24105
Germany
Trial participating centre
Analyze & Realize AG
Berlin
10369
Germany
Trial participating centre
Leatherhead Food Research
Leatherhead
KT22 7RY
United Kingdom
Trial participating centre
SynteractHCR
Clinical Unit
Munich
80636
Germany
Funders
Funder type
Industry
Funder name
Chr. Hansen A/S (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study results will be published in an international scientific journal in 2015.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26382580