Condition category
Digestive System
Date applied
23/01/2015
Date assigned
04/02/2015
Last edited
21/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Lillian Jespersen

ORCID ID

Contact details

Chr. Hansen A/S
Boege Alle 10-12
Hoersholm
2970
Denmark

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 measures

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

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

Sponsor information

Organisation

Chr. Hansen A/S

Sponsor details

Boege Alle 10-12
Hoersholm
2970
Denmark

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26382580

Publication citations

Additional files

Editorial Notes