Effect of the probiotic strain BB-12® on the gastrointestinal function of healthy adults
| ISRCTN | ISRCTN18128385 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18128385 |
| Secondary identifying numbers | HND-GI-004 |
- Submission date
- 23/01/2015
- Registration date
- 04/02/2015
- Last edited
- 21/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Chr. Hansen A/S
Boege Alle 10-12
Hoersholm
2970
Denmark
Study information
| Study design | Randomised double-blind placebo-controlled multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1740 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- England
- France
- Germany
- United Kingdom
Study participating centres
38610
France
69310
France
68167
Germany
41061
Germany
24105
Germany
10369
Germany
KT22 7RY
United Kingdom
Munich
80636
Germany
Sponsor information
Industry
Boege Alle 10-12
Hoersholm
2970
Denmark
"ROR" |
https://ror.org/01mv6bt66 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study results will be published in an international scientific journal in 2015. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/11/2015 | Yes | No |
