Effect of the probiotic strain BB-12® on the gastrointestinal function of healthy adults

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18128385

Enrollment

1740

Registered

2015-02-04

Start date

2010-09-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Low defecation frequency and abdominal discomfort Digestive System Low defecation frequency and abdominal discomfort

Interventions

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®

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

France, Germany, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026