Clinical trial NCT02155972 - References

Bipolar Depression — The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression

Citation(s)

•   American Psychiatric Association
  Practice guideline for the treatment of patients with bipolar disorder (revision). Am J Psychiatry. 2002 Apr;159(4 Suppl):1-50.
•   Arbuckle R, Frye MA, Brecher M, Paulsson B, Rajagopalan K, Palmer S, Degl' Innocenti A
  The psychometric validation of the Sheehan Disability Scale (SDS) in patients with bipolar disorder. Psychiatry Res. 2009 Jan 30;165(1-2):163-74. doi: 10.1016/j.psychres.2007.11.018. Epub 2008 Nov 29.
•   Bailey MT, Coe CL
  Maternal separation disrupts the integrity of the intestinal microflora in infant rhesus monkeys. Dev Psychobiol. 1999 Sep;35(2):146-55.
•   Bailey MT, Lubach GR, Coe CL
  Prenatal stress alters bacterial colonization of the gut in infant monkeys. J Pediatr Gastroenterol Nutr. 2004 Apr;38(4):414-21.
•   Baldessarini RJ, Tondo L
  Suicide risk and treatments for patients with bipolar disorder. JAMA. 2003 Sep 17;290(11):1517-9. Erratum in: JAMA. 2004 Jan 14;291(2):186.
•   Bartram AK, Lynch MD, Stearns JC, Moreno-Hagelsieb G, Neufeld JD
  Generation of multimillion-sequence 16S rRNA gene libraries from complex microbial communities by assembling paired-end illumina reads. Appl Environ Microbiol. 2011 Jun;77(11):3846-52. doi: 10.1128/AEM.02772-10. Epub 2011 Apr 1. Erratum in: Appl Environ Microbiol. 2011 Aug;77(15):5569.
•   Bauserman M, Michail S
  The use of Lactobacillus GG in irritable bowel syndrome in children: a double-blind randomized control trial. J Pediatr. 2005 Aug;147(2):197-201. Erratum in: J Pediatr. 2014 Oct;165(4):878. Bausserman, Melissa [corrected to Bauserman, Melissa].
•   Bercik P, Verdu EF, Foster JA, Macri J, Potter M, Huang X, Malinowski P, Jackson W, Blennerhassett P, Neufeld KA, Lu J, Khan WI, Corthesy-Theulaz I, Cherbut C, Bergonzelli GE, Collins SM
  Chronic gastrointestinal inflammation induces anxiety-like behavior and alters central nervous system biochemistry in mice. Gastroenterology. 2010 Dec;139(6):2102-2112.e1. doi: 10.1053/j.gastro.2010.06.063. Epub 2010 Jun 27.
•   Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF
  Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
•   Brietzke E, Stertz L, Fernandes BS, Kauer-Sant'anna M, Mascarenhas M, Escosteguy Vargas A, Chies JA, Kapczinski F
  Comparison of cytokine levels in depressed, manic and euthymic patients with bipolar disorder. J Affect Disord. 2009 Aug;116(3):214-7. doi: 10.1016/j.jad.2008.12.001. Epub 2009 Feb 28.
•   Calabrese JR, Kasper S, Johnson G, Tajima O, Vieta E, Yatham LN, Young AH
  International Consensus Group on Bipolar I Depression Treatment Guidelines. J Clin Psychiatry. 2004 Apr;65(4):571-9. Review.
•   Camilleri M
  Probiotics and irritable bowel syndrome: rationale, putative mechanisms, and evidence of clinical efficacy. J Clin Gastroenterol. 2006 Mar;40(3):264-9. Review.
•   Creed F, Ratcliffe J, Fernandes L, Palmer S, Rigby C, Tomenson B, Guthrie E, Read N, Thompson DG; North of England IBS Research Group
  Outcome in severe irritable bowel syndrome with and without accompanying depressive, panic and neurasthenic disorders. Br J Psychiatry. 2005 Jun;186:507-15.
•   Cryan JF, O'Mahony SM
  The microbiome-gut-brain axis: from bowel to behavior. Neurogastroenterol Motil. 2011 Mar;23(3):187-92. doi: 10.1111/j.1365-2982.2010.01664.x.
•   Culligan EP, Hill C, Sleator RD
  Probiotics and gastrointestinal disease: successes, problems and future prospects. Gut Pathog. 2009 Nov 23;1(1):19. doi: 10.1186/1757-4749-1-19.
•   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. doi: 10.1016/j.jpsychires.2008.03.009. Epub 2008 May 5.
•   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 Nov 10;170(4):1179-88. doi: 10.1016/j.neuroscience.2010.08.005. Epub 2010 Aug 6.
•   Diaz Heijtz R, Wang S, Anuar F, Qian Y, Björkholm B, Samuelsson A, Hibberd ML, Forssberg H, Pettersson S
  Normal gut microbiota modulates brain development and behavior. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3047-52. doi: 10.1073/pnas.1010529108. Epub 2011 Jan 31.
•   Duke K, Murphy S, Smith M
  Probiotic performance in IBD is not uniform: a multi-strain comparison in the lymphocyte transfer model of enterocolitis. Gastroenterology. 2004;126:A283-A284.
•   Eutamene H, Bueno L
  Role of probiotics in correcting abnormalities of colonic flora induced by stress. Gut. 2007 Nov;56(11):1495-7.
•   Fitzgerald P, Cassidy Eugene M, Clarke G, Scully P, Barry S, Quigley Eamonn MM, Shanahan F, Cryan J, Dinan Timothy G
  Tryptophan catabolism in females with irritable bowel syndrome: relationship to interferon-gamma, severity of symptoms and psychiatric co-morbidity. Neurogastroenterol Motil. 2008 Dec;20(12):1291-7. doi: 10.1111/j.1365-2982.2008.01195.x. Epub 2008 Sep 24.
•   Forsythe P, Sudo N, Dinan T, Taylor VH, Bienenstock J
  Mood and gut feelings. Brain Behav Immun. 2010 Jan;24(1):9-16. doi: 10.1016/j.bbi.2009.05.058. Epub 2009 May 28. Review.
•   Garakani A, Win T, Virk S, Gupta S, Kaplan D, Masand PS
  Comorbidity of irritable bowel syndrome in psychiatric patients: a review. Am J Ther. 2003 Jan-Feb;10(1):61-7. Review.
•   Gareau MG, Jury J, MacQueen G, Sherman PM, Perdue MH
  Probiotic treatment of rat pups normalises corticosterone release and ameliorates colonic dysfunction induced by maternal separation. Gut. 2007 Nov;56(11):1522-8. Epub 2007 Mar 5. Erratum in: Gut. 2008 Apr;57(4):560.
•   Gaykema RP, Goehler LE, Lyte M
  Brain response to cecal infection with Campylobacter jejuni: analysis with Fos immunohistochemistry. Brain Behav Immun. 2004 May;18(3):238-45.
•   Girard SA, Bah TM, Kaloustian S, Lada-Moldovan L, Rondeau I, Tompkins TA, Godbout R, Rousseau G
  Lactobacillus helveticus and Bifidobacterium longum taken in combination reduce the apoptosis propensity in the limbic system after myocardial infarction in a rat model. Br J Nutr. 2009 Nov;102(10):1420-5. doi: 10.1017/S0007114509990766. Epub 2009 Jun 29.
•   Gitlin MJ, Mintz J, Sokolski K, Hammen C, Altshuler LL
  Subsyndromal depressive symptoms after symptomatic recovery from mania are associated with delayed functional recovery. J Clin Psychiatry. 2011 May;72(5):692-7. doi: 10.4088/JCP.09m05291gre. Epub 2010 Jun 29.
•   Goehler LE, Gaykema RP, Opitz N, Reddaway R, Badr N, Lyte M
  Activation in vagal afferents and central autonomic pathways: early responses to intestinal infection with Campylobacter jejuni. Brain Behav Immun. 2005 Jul;19(4):334-44.
•   Goehler LE, Park SM, Opitz N, Lyte M, Gaykema RP
  Campylobacter jejuni infection increases anxiety-like behavior in the holeboard: possible anatomical substrates for viscerosensory modulation of exploratory behavior. Brain Behav Immun. 2008 Mar;22(3):354-66. Epub 2007 Oct 24.
•   Goldstein BI, Kemp DE, Soczynska JK, McIntyre RS
  Inflammation and the phenomenology, pathophysiology, comorbidity, and treatment of bipolar disorder: a systematic review of the literature. J Clin Psychiatry. 2009 Aug;70(8):1078-90. doi: 10.4088/JCP.08r04505. Epub 2009 Jun 2. Review.
•   Goncharova GI, Liz'ko NN, Liannaia AM, Shilov VM, Spitsa TI
  [Bifidobacterium flora status of cosmonauts before and after completing space flights]. Kosm Biol Aviakosm Med. 1981;15(3):14-8. Russian.
•   Goodwin GM; Consensus Group of the British Association for Psychopharmacology
  Evidence-based guidelines for treating bipolar disorder: recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2003 Jun;17(2):149-73; discussion 147.
•   Guloksuz S, Cetin EA, Cetin T, Deniz G, Oral ET, Nutt DJ
  Cytokine levels in euthymic bipolar patients. J Affect Disord. 2010 Nov;126(3):458-62. doi: 10.1016/j.jad.2010.04.027.
•   Guy W
  Global Impression Scale. ECDEU Assessment Manual for Psychopharmacology-Revised. 1976.
•   Hamilton-Miller JMT
  Probiotics in the Management of Irritable Bowel Syndrome: A Review of Clinical Trials. Microbial Ecology in Health & Disease 2001;13:212-216
•   Joffe RT, MacQueen GM, Marriott M, Trevor Young L
  A prospective, longitudinal study of percentage of time spent ill in patients with bipolar I or bipolar II disorders. Bipolar Disord. 2004 Feb;6(1):62-6.
•   Judd LL, Akiskal HS, Schettler PJ, Coryell W, Endicott J, Maser JD, Solomon DA, Leon AC, Keller MB
  A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry. 2003 Mar;60(3):261-9.
•   Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, Leon AC, Rice JA, Keller MB
  The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry. 2002 Jun;59(6):530-7.
•   Kajander K, Hatakka K, Poussa T, Färkkilä M, Korpela R
  A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6-month intervention. Aliment Pharmacol Ther. 2005 Sep 1;22(5):387-94.
•   Kauer-Sant'Anna M, Kapczinski F, Andreazza AC, Bond DJ, Lam RW, Young LT, Yatham LN
  Brain-derived neurotrophic factor and inflammatory markers in patients with early- vs. late-stage bipolar disorder. Int J Neuropsychopharmacol. 2009 May;12(4):447-58. doi: 10.1017/S1461145708009310. Epub 2008 Sep 4.
•   Kim HJ, Camilleri M, McKinzie S, Lempke MB, Burton DD, Thomforde GM, Zinsmeister AR
  A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2003 Apr 1;17(7):895-904.
•   Kim HJ, Vazquez Roque MI, Camilleri M, Stephens D, Burton DD, Baxter K, Thomforde G, Zinsmeister AR
  A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil. 2005 Oct;17(5):687-96.
•   Klooker TK, Braak B, Painter RC, de Rooij SR, van Elburg RM, van den Wijngaard RM, Roseboom TJ, Boeckxstaens GE
  Exposure to severe wartime conditions in early life is associated with an increased risk of irritable bowel syndrome: a population-based cohort study. Am J Gastroenterol. 2009 Sep;104(9):2250-6. doi: 10.1038/ajg.2009.282. Epub 2009 Jun 9.
•   Kunz M, Ceresér KM, Goi PD, Fries GR, Teixeira AL, Fernandes BS, Belmonte-de-Abreu PS, Kauer-Sant'Anna M, Kapczinski F, Gama CS
  Serum levels of IL-6, IL-10 and TNF-a in patients with bipolar disorder and schizophrenia: differences in pro- and anti-inflammatory balance. Rev Bras Psiquiatr. 2011 Sep;33(3):268-74.
•   Li W, Dowd SE, Scurlock B, Acosta-Martinez V, Lyte M
  Memory and learning behavior in mice is temporally associated with diet-induced alterations in gut bacteria. Physiol Behav. 2009 Mar 23;96(4-5):557-67. doi: 10.1016/j.physbeh.2008.12.004. Epub 2008 Dec 24.
•   Logan AC, Katzman M
  Major depressive disorder: probiotics may be an adjuvant therapy. Med Hypotheses. 2005;64(3):533-8.
•   Lyte M, Li W, Opitz N, Gaykema RP, Goehler LE
  Induction of anxiety-like behavior in mice during the initial stages of infection with the agent of murine colonic hyperplasia Citrobacter rodentium. Physiol Behav. 2006 Oct 30;89(3):350-7. Epub 2006 Aug 2.
•   Marks DM, Han C, Krulewicz S, Pae CU, Peindl K, Patkar AA, Masand PS
  History of depressive and anxiety disorders and paroxetine response in patients with irritable bowel syndrome: post hoc analysis from a placebo-controlled study. Prim Care Companion J Clin Psychiatry. 2008;10(5):368-75.
•   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.
•   Montgomery SA, Asberg M
  A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9.
•   Neufeld KM, Kang N, Bienenstock J, Foster JA
  Reduced anxiety-like behavior and central neurochemical change in germ-free mice. Neurogastroenterol Motil. 2011 Mar;23(3):255-64, e119. doi: 10.1111/j.1365-2982.2010.01620.x. Epub 2010 Nov 5.
•   Niv E, Naftali T, Hallak R, Vaisman N
  The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome--a double blind, placebo-controlled, randomized study. Clin Nutr. 2005 Dec;24(6):925-31. Epub 2005 Jul 27.
•   O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EM
  Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005 Mar;128(3):541-51.
•   O'Mahony SM, Marchesi JR, Scully P, Codling C, Ceolho AM, Quigley EM, Cryan JF, Dinan TG
  Early life stress alters behavior, immunity, and microbiota in rats: implications for irritable bowel syndrome and psychiatric illnesses. Biol Psychiatry. 2009 Feb 1;65(3):263-7. doi: 10.1016/j.biopsych.2008.06.026. Epub 2008 Aug 23.
•   Padmos RC, Van Baal GC, Vonk R, Wijkhuijs AJ, Kahn RS, Nolen WA, Drexhage HA
  Genetic and environmental influences on pro-inflammatory monocytes in bipolar disorder: a twin study. Arch Gen Psychiatry. 2009 Sep;66(9):957-65. doi: 10.1001/archgenpsychiatry.2009.116.
•   Post RM, Denicoff KD, Leverich GS, Altshuler LL, Frye MA, Suppes TM, Rush AJ, Keck PE Jr, McElroy SL, Luckenbaugh DA, Pollio C, Kupka R, Nolen WA
  Morbidity in 258 bipolar outpatients followed for 1 year with daily prospective ratings on the NIMH life chart method. J Clin Psychiatry. 2003 Jun;64(6):680-90; quiz 738-9.
•   Post RM, Leverich GS, Nolen WA, Kupka RW, Altshuler LL, Frye MA, Suppes T, McElroy S, Keck P, Grunze H, Walden J; Stanley Foundation Bipolar Network
  A re-evaluation of the role of antidepressants in the treatment of bipolar depression: data from the Stanley Foundation Bipolar Network. Bipolar Disord. 2003 Dec;5(6):396-406. Review.
•   Rao AV, Bested AC, Beaulne TM, Katzman MA, Iorio C, Berardi JM, Logan AC
  A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. Gut Pathog. 2009 Mar 19;1(1):6. doi: 10.1186/1757-4749-1-6.
•   Rhee SH, Pothoulakis C, Mayer EA
  Principles and clinical implications of the brain-gut-enteric microbiota axis. Nat Rev Gastroenterol Hepatol. 2009 May;6(5):306-14. doi: 10.1038/nrgastro.2009.35. Review.
•   Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines Team for Bipolar Disorder
  Australian and New Zealand clinical practice guidelines for the treatment of bipolar disorder. Aust N Z J Psychiatry. 2004 May;38(5):280-305. Review.
•   Silk DB, Davis A, Vulevic J, Tzortzis G, Gibson GR
  Clinical trial: the effects of a trans-galactooligosaccharide prebiotic on faecal microbiota and symptoms in irritable bowel syndrome. Aliment Pharmacol Ther. 2009 Mar 1;29(5):508-18. doi: 10.1111/j.1365-2036.2008.03911.x. Epub 2008 Dec 2.
•   Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group
  The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310.
•   Spielberger CD
  Manual for the State-Trait Anxiety Inventory. Corsini Encyclopedia of Psychology. 1. Palo Alto, CA: Consulting Psychologists Press; 1983
•   Sudo N, Chida Y, Aiba Y, Sonoda J, Oyama N, Yu XN, Kubo C, Koga Y
  Postnatal microbial colonization programs the hypothalamic-pituitary-adrenal system for stress response in mice. J Physiol. 2004 Jul 1;558(Pt 1):263-75. Epub 2004 May 7.
•   Sullivan A, Nord CE
  Probiotics and gastrointestinal diseases. J Intern Med. 2005 Jan;257(1):78-92. Review.
•   Suppes T, Dennehy EB, Hirschfeld RM, Altshuler LL, Bowden CL, Calabrese JR, Crismon ML, Ketter TA, Sachs GS, Swann AC; Texas Consensus Conference Panel on Medication Treatment of Bipolar Disorder
  The Texas implementation of medication algorithms: update to the algorithms for treatment of bipolar I disorder. J Clin Psychiatry. 2005 Jul;66(7):870-86.
•   Suzuki K, Harasawa R, Yoshitake Y, Mitsuoka T
  Effects of crowding and heat stress on intestinal flora, body weight gain, and feed efficiency of growing rats and chicks. Nihon Juigaku Zasshi. 1983 Jun;45(3):331-8.
•   Tannock GW, Savage DC
  Influences of dietary and environmental stress on microbial populations in the murine gastrointestinal tract. Infect Immun. 1974 Mar;9(3):591-8.
•   Verdu EF
  Probiotics effects on gastrointestinal function: beyond the gut? Neurogastroenterol Motil. 2009 May;21(5):477-80. doi: 10.1111/j.1365-2982.2009.01297.x.
•   Whitehead WE, Palsson O, Jones KR
  Systematic review of the comorbidity of irritable bowel syndrome with other disorders: what are the causes and implications? Gastroenterology. 2002 Apr;122(4):1140-56. Review.
•   Young RC, Biggs JT, Ziegler VE, Meyer DA
  A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35.

The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression: a Proof of Concept Randomized Controlled Trial

Details for clinical trial NCT02155972