For healthcare professionals interested in additional scientific information and data regarding probiotics, this section provides a listing of:
- Probiotic Review Articles
- Bifidobacterium infantis 35624 Clinical Data Publications
- Bifidobacterium infantis 35624 Preclinical Data Publications
- Bifidobacterium infantis 35624 Review Articles
Probiotic Review 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, Guandalini S, Hibberd P, Gorbach S, Surawicz C, Sanders ME, Garcia-Tsao G, Quigley EM, Isolauri E, Fedorak RN, Dieleman LA. Recommendations for probiotic use—2008. J Clin Gastroenterol 2008 Jul;42 Suppl 2:S104-8.
- Douglas LC, Sanders ME. Probiotics and prebiotics in dietetics practice. J Am Diet Assoc 2008 Mar;108(3):510-21.
- World Gastroenterology Organisation Practice Guideline. Probiotics and Prebiotics. 2008 May.
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 an additional clinical trial currently being prepared for publication is also provided.- Whorwell PJ, Altringer L, Morel J, Bond Y, Charbonneau D, O'Mahony L, Kiely B, Shanahan F, Quigley EMM. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006 Jul;101(7):1581-90.
- O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen KS, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EMM. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005 Mar;128(3):541-51.
- A double-blind, randomized, placebo-controlled study of the effects of Bifantis (Bifidobacterium infantis 35624) on fecal microflora and gastrointestinal symptoms in adults with irritable bowel syndrome. P&G Study 2005054 (Data on file, Procter & Gamble).
Objectives
Primary: To determine the impact of B. infantis 35624 vs. placebo on fecal microflora in IBS subjects
Secondary: To assess the impact of B. infantis 35624 on IBS-related symptoms in IBS subjects and fecal microflora in healthy subjectsStudy design: Single-center, multiple-dose, double-blind, randomized, parallel-group, placebo-controlled study consisting of 3 consecutive phases: 2-week baseline; 8-week dosing; and 2-week follow-up Key inclusion criteria: Male or female subjects, 18 to 65 years of age, who had symptoms of IBS consistent with the Rome II Diagnostic Criteria and a group of age- and gender-matched healthy subjects Key exclusion criteria: History of milk/soy allergies; pregnancy or nursing; IBS symptoms predominantly related to menstruation; symptoms suggestive of an underlying disease (weight loss, nocturnal symptoms, blood in stools, family history of colorectal cancer, short duration of symptoms, progressive deterioration of symptoms, or abnormal proctoscopy/abdominal ultrasound that required further investigation); prior gastrointestinal surgery; immunodeficiency Outcome measures
Primary: Total B. infantis 35624 PCR count in the per-protocol IBS population at Week 8 of the dosing phase.
Secondary: 17 measurements of bacterial species and groups; 10 variables relating to daily assessments of IBS-related symptoms (IBS subjects only); weekly assessments of 6 IBS-related symptoms (IBS subjects only)Treatments
39 IBS patients received 1 capsule/day of 1 x 109 CFU (colony forming units) B. infantis 35624. 37 IBS patients received 1 capsule/day of placebo. 41 healthy patients received 1 capsule/day of 1 x 109 CFU B. infantis 35624.Subject demographics/disposition IBS Patients Healthy Subjects Placebo B. infantis B. infantis Sex: Female 31 (84%) 31 (79%) 33 (80%) Age (mean) 43 47 44 Race: Caucasian
Black
Hispanic30 (81%)
7 (19%)
028 (72%)
10 (26%)
1 (3%)34 (83%)
6 (15%)
1 (2%)The active and placebo groups in the IBS population were balanced at baseline with respect to race, age, height and weight, alcohol use, and smoking status. Twenty subjects did not complete the study; 9 subjects discontinued due to treatment-emergent adverse effects (IBS placebo = 5, IBS B. infantis = 2, Healthy = 2). Efficacy results:
Primary:
The mean change from baseline in total B. infantis 35624 PCR count for IBS subjects at Week 8 was significantly greater in the B. infantis group compared with placebo (p < 0.01).Secondary: - Total B. infantis 35624 PCR count was significantly increased vs. baseline values in healthy subjects who received B. infantis (p < 0.0001).
- Microbiology measures—Only 1 measure was statistically different in B. infantis-treated IBS subjects vs. placebo at Week 4, Week 8, or Follow-up (Clostridium coccoides Eubacterium rectale was higher in the B. infantis group at Week 8 [p = 0.03] but not at Week 4 or Follow-up).
- Daily IBS symptom assessments—No statistically significant differences between groups were observed at any time-point.
- Weekly IBS symptom assessments—No statistically significant differences were observed between groups during any week except for one parameter at Week 3 (placebo showed greater reduction in severity of abdominal pain compared with B. infantis, p = 0.04).
Adverse effects: Treatments were generally well tolerated. There was 1 serious adverse event of acute viral infection in a placebo subject. The only AE that were reported more frequently in IBS subjects on B. infantis compared to IBS subjects on placebo was sore throat (4 mild vs. 0). No severe adverse events were reported for any patient. Conclusions: This study demonstrated a highly significant difference in fecal microflora as measured by total B. infantis 35624 PCR count at Week 8 of dosing with 1 x 109 B. infantis 35624 CFU/capsule/dose vs. placebo in subjects with IBS. Publication: A full manuscript is in preparation.
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.*
- 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.
- 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.*- Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol 2009 Apr;104(4):1033-49.
- Brenner DM, Chey WD. Bifidobacterium infantis 35624: a novel probiotic for the treatment of irritable bowel syndrome. Rev Gastroenterol Disord 2009 Winter;9(1):7-15.
- Parkes GC, Brostoff J, Whelan K, Sanderson JD. Gastrointestinal microbiota in irritable bowel syndrome: their role in its pathogenesis and treatment. Am J Gastroenterol 2008 Jun;103(6):1557-67.
- O'Sullivan GC, Kelly P, O'Halloran S, Collins C, Collins JK, Dunne C, Shanahan F. Probiotics: an emerging therapy. Curr Pharm Des 2005;11(1):3-10.
- 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.
* The following electronic databases were searched in August 2009 for articles citing Bifidobacterium infantis 35624 in the title or abstract: PUBMED, MEDLINE, EMBASE, BIOSIS, HCAPLUS, SCISEARCH, and IPA.
