HEALTH CARE PROFESSIONALS

Probiotic Scientific Data and Resources for Professionals

For healthcare professionals interested in additional scientific information and data regarding probiotics, this section provides a listing of:

Probiotic Articles

The following probiotic review articles and references provide additional information on available probiotics.

Bifidobacterium infantis 35624 Clinical Data Publications*

If you are interested in additional scientific information and data regarding Bifidobacterium infantis 35624, below is a list of clinical publications.* A brief summary of additional clinical trials also is provided.

Additional clinical data. A brief summary of an additional clinical trial that was presented at the 2011 American College of Gastroenterology Annual Scientific Meeting in Washington, DC is presented below.

Ringel Y, Ringel-Kulka T, McKean L, Ramsey D, Gibb R, McRorie J. Probiotic Bifidobacterium longum subsp. infantis 35624 in a non-patient population with a history of abdominal discomfort and bloating. Am J Gastroenterol. 2011 Oct;106(Suppl 2):S503. Abstract 1318.

A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the benefit of a probiotic (Bifidobacterium infantis 35624) in healthy subjects with a history of abdominal discomfort and bloating.

Study Objective To evaluate the benefit of B. infantis 35624 compared to placebo for abdominal discomfort and bloating in healthy subjects.

Study design: Multicenter, double-blind, randomized, parallel-group, placebo-controlled study consisting of 2 consecutive phases: a 2-week placebo run-in phase, followed by a 4-week treatment phase. Key inclusion criteria: Male or female subjects, 18 to 75 years of age, in general good health with BMI ≤ 40 who experienced abdominal discomfort and bloating at least twice a week, on average, over the last 3 months.

Key exclusion criteria: Pregnant or nursing; abdominal discomfort and bloating predominantly related to menstruation; under a physician's care for functional bowel disorders (i.e., IBS, functional constipation, functional diarrhea, functional abdominal pain) or have taken prescription medication for functional bowel disorders within the past year; alarm symptoms suggestive of an underlying disease (weight loss, blood in stools, family history of colorectal cancer, relevant abnormalities on physical exam, acute onset of symptoms, subjects with diarrhea due to mal-absorptive disorders, abnormal lab test, positive stool cultures in subjects with prolonged diarrhea); prior gastrointestinal surgery; immunodeficiency.

Outcome measures

  • Primary: Change from baseline in severity of each symptom (abdominal discomfort and bloating) at Week 4
  • Secondary: Change from baseline in severity of each symptom (abdominal discomfort and bloating) at Weeks 1, 2, and 3; subject reported global impression of change; time to no symptoms; proportion of days without symptoms

Treatments: 148 healthy non-patient subjects received 1 capsule/day of 1 x 109 CFU (colony-forming unit) B. infantis 35624. 154 healthy non-patient subjects received 1 capsule/day of placebo.

Subject demographics/disposition: subject demographics disposiiton The active and placebo groups were balanced at baseline with respect to race, age, sex, ethnicity, smoking status, alcohol use, and caffeine use. A total of 10 subjects did not complete the study; 1 subject discontinued due to an adverse event.

Efficacy results:

  • Primary: Both groups showed significant (p < 0.05) improvement versus baseline in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at Week 4 show no significant differences between the probiotic and placebo groups in either abdominal discomfort or bloating (p > 0.3).
  • Secondary:

    • No significant differences between the probiotic and placebo groups were noted in severity of symptom scores at Weeks 1, 2, or 3 or in the subject-reported global impression of change.
    • Subjects in the B. infantis 35624 group had significantly more bloating-free days compared with subjects in the placebo group (p < 0.05, 1-sided).

Adverse effects: Treatments were generally well tolerated. Both the B. infantis 35624 and placebo groups had an adverse event rate of 10%. The most commonly reported adverse events were gastrointestinal in nature. The majority of the adverse events was mild or moderate in severity and doubtfully related to study product. There was 1 serious adverse event of severe abdominal pain after 1 dose in a B. infantis 35624 subject.

Conclusions: Both groups showed significant (p < 0.05) improvement in abdominal discomfort and bloating scores versus baseline over the 4-week intervention period. B. infantis 35624 did not show a significant improvement versus placebo in the mean severity of abdominal discomfort and bloating in a healthy, non-patient population. This may be explained by the high placebo effect and the lower severity, frequency, and impact of functional bowel symptoms in the non-patient population.

Publication: Ringel Y, Ringel-Kulka T, McKean L, Ramsey D, Gibb R, McRorie J. Probiotic Bifidobacterium longum subsp. infantis 35624 in a non-patient population with a history of abdominal discomfort and bloating. Am J Gastroenterol. 2011 Oct;106(Suppl 2):S503. Abstract 1318.

Bifidobacterium infantis 35624 Preclinical Data Publications*

If you are interested in additional scientific information and data regarding Bifidobacterium infantis 35624, below is a list of preclinical publications.*

Bifidobacterium infantis 35624 Review Articles*

If you are interested in additional scientific information and data regarding Bifidobacterium infantis 35624, below is a list of review articles.*

Professional Resources

If you are interested in obtaining additional information about probiotics, the following resources cover a range of related topics.

American College of Gastroenterology Probiotics for the treatment of adult gastrointestinal disorders.

National Center for Complementary and Alternative Medicine Get the Facts: An Introduction to Probiotics

World Gastroenterology Organisation Probiotics and Prebiotics

Reference to institutions and agencies is provided for informational purposes only and does not suggest an endorsement or approval of Bifantis®.

*The following electronic databases were searched in March 2012 for articles citing Bifidobacterium infantis 35624 in the title or abstract: PUBMED, MEDLINE, EMBASE, BIOSIS, HCAPLUS, SCISEARCH, and IPA.

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§Fortifies your digestive system 24/7 with continued daily use.*

Among Gastroenterologists who recommended a brand of probiotic in a ProVoice 2008-2018 survey.

Among Doctors who recommended a brand of probiotic in ProVoice 2013-2018 surveys.

*THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.