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
• Bifidobacterium infantis 35624 Clinical Data Publications
• Bifidobacterium infantis 35624 Preclinical Data Publications
• Bifidobacterium infantis 35624 Review Articles
• Professional Resources

Probiotic Articles

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

• Kligler B, Cohrssen A. Probiotics. Am Fam Physician 2008 Nov 1;78(9):1073-8.
• Floch MH, Walker WA, Madsen K, Sanders ME, Macfarlane GT, Flint HJ, Dieleman LA, Ringel Y, Guandalini S, Kelly CP, Brandt LJ. Recommendations for probiotic use—2011 update. J Clin Gastroenterol 2011 Nov; 45 Suppl:S168-71.
• Douglas LC, Sanders ME. Probiotics and prebiotics in dietetics practice. J Am Diet Assoc 2008 Mar;108(3):510-21.
• World Gastroenterology Organisation Global Guidelines. Probiotics and Prebiotics. 2011 October. www.worldgastroenterology.org/probiotics-prebiotics.html.
• Brenner DM. Probiotics for the treatment of adult gastrointestinal disorders. www.patients.gi.org/topics/probiotics-for-the-treatment-of-adult-gastrointestinal-disorders/.

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.

• Charbonneau D, Gibb RD, Quigley EM. Fecal excretion of Bifidobacterium infantis 35624 and changes in fecal microbiota after eight weeks of oral supplementation with encapsulated probiotic. Gut Microbes. 2013 May-Jun;4(3):201-11.

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: 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.*

• Konieczna P, Groeger D, Ziegler M, Frei, R, Ferstl R, Shanahan F, Quigley EM, Kiely B, Akdis CA, O'Mahony L. Bifidobacterium infantis 35624 administration induces Foxp3 T Regulatory cells in human peripheral blood: potential role for myeloid and plasmacytoid dendritic cells. Gut. 2012 Mar;61(3):354-66.
• Johnson AC, Greenwood-Van Meerveld B, McRorie J. Effects of Bifidobacterium infantis 35624 on Post-Inflammatory Visceral Hypersensitivity in the Rat. Dig Dis Sci. 2011 Nov;56(11):3179-86.
• Gad M, Ravn P, Søborg DA, Lund-Jensen K, Ouwehand AC, Jensen SS. Regulation of the IL-10/IL-12 axis in human dendritic cells with probiotic bacteria. FEMS Immunol Med Microbiol. 2011 Oct;63(1):93-107.
• Desbonnet L, Garrett L, Clarke G, Kiely B, Cryan JF, Dinan TG. Effects of the probiotic Bifidobacterium infantis in the maternal separation model of depression. Neuroscience. 2010; 170(4):1179-88.
• McKernan DP, Fitzgerald P, Dinan TG, Cryan JF. The probiotic Bifidobacterium infantis 35624 displays visceral antinociceptive effects in the rat. Neurogastroenterol Motil. 2010 Sep;22(9):1029-35.
• Sibartie S, O'Hara AM, Ryan J, Fanning A, O'Mahony J, O'Neill S, Sheil B, O'Mahony L, Shanahan F. Modulation of pathogen-induced CCL20 secretion from HT-29 human intestinal epithelial cells by commensal bacteria. BMC Immunol. 2009 Oct 8;10:54.
• Desbonnet L, Garrett, L, Clarke G, Bienenstock J, Dinan TG. The probiotic Bifidobacteria infantis: an assessment of potential antidepressant properties in the rat. J Psychiatr Res 2008 Dec;43(2):164-74.
• O'Mahony C, Scully P, O'Mahony D, Murphy S, O'Brien F, Lyons A, Sherlock G, MacSharry J, Kiely B, Shanahan F, O'Mahony L. Commensal-induced regulatory T cells mediate protection against pathogen-stimulated NF-kappaB activation. PLoS Pathog 2008 Aug 1;4(8):e1000112.
• Van der Kleij H, O'Mahony C, Shanahan F, O'Mahony L, Bienenstock J. Protective effects of Lactobacillus reuteri and Bifidobacterium infantis in murine models for colitis do not involve the vagus nerve. Am J Physiol Regul Integr Comp Physiol. 2008 Oct;295(4):R1131-7.
• O'Hara AM, O'Regan P, Fanning A, O'Mahony C, Macsharry J, Lyons A, Bienenstock J, O'Mahony L, Shanahan F. Functional modulation of human intestinal epithelial cell responses by Bifidobacterium infantis and Lactobacillus salivarius. Immunology 2006 Jun;118(2):202-15.
• Sheil B, MacSharry J, O'Callaghan L, O'Riordan A, Waters A, Morgan J, Collins JK, O'Mahony L, Shanahan F. Role of interleukin (IL-10) in probiotic-mediated immune modulation: an assessment in wild-type and IL-10 knock-out mice. Clin Exp Immunol 2006 May;144(2):273-80.
• O'Mahony L, O'Callaghan L, McCarthy J, Shilling D, Scully P, Sibartie S, Kavanagh E, Kirwan WO, Redmond HP, Collins JK, Shanahan F. Differential cytokine response from dendritic cells to commensal and pathogenic bacteria in different lymphoid compartments in humans. Am J Physiol Gastrointest Liver Physiol 2006 Apr;290(4):G839-45.
• Gilman J, Cashman KD. The effect of probiotic bacteria on transepithelial calcium transport and calcium uptake in human intestinal-like Caco-2 cells. Curr Issues Intest Microbiol 2006 Mar;7(1):1-5.
• McCarthy J, O'Mahony L, O'Callaghan L, Sheil B, Vaughan EE, Fitzsimons N, Fitzgibbon J, O'Sullivan GC, Kiely B, Collins JK, Shanahan F. Double blind, placebo controlled trial of two probiotic strains in interleukin 10 knockout mice and mechanistic link with cytokine balance. Gut. 2003 Jul;52(7):975-80.
• MacConaill LE, Butler D, O'Connell-Motherway M, Fitzgerald GF, van Sinderen D. Identification of two-component regulatory systems in Bifidobacterium infantis by functional complementation and degenerate PCR approaches. Appl Environ Microbiol 2003 Jul;69(7):4219-26.

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.*

• Dunne C, Murphy L, Flynn S, O'Mahony L, O'Halloran S, Feeney M, Morrissey D, Thornton G, Fitzgerald G, Daly C, Kiely B, Quigley EM, O'Sullivan GC, Shanahan F, Collins JK. Probiotics: from myth to reality. Demonstration of functionality in animal models of disease and in human clinical trials. Antonie Van Leeuwenhoek.1999 Jul-Nov;76(1-4):279-92.

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.