Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial

References

• Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: Systematic review and meta-analysis. American journal of gastroenterology. 2011;106:1582–91. doi:10.1038/ajg.2011.164.
   PubMed Web of Science ®Google Scholar
• Tramonte SM, Brand MB, Mulrow CD, Amato MG, O'Keefe ME, Ramirez G. The treatment of chronic constipation in adults. Journal of General Internal Medicine. 1997;12:15–24. doi:10.1007/s11606-006-0003-5.
   PubMed Web of Science ®Google Scholar
• Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. Journal of Gastrointestinal and Liver Diseases. 2006;15:237.
   PubMedGoogle Scholar
• Drossman DA. The functional gastrointestinal disorders and the Rome III process. gastroenterology. 2006;130:1377–90. doi:10.1053/j.gastro.2006.03.008.
   PubMed Web of Science ®Google Scholar
• Bouchoucha M, Devroede G, Faye A, Le Toumelin P, Arhan P, Arsac M. Colonic response to food in constipation. International journal of colorectal disease. 2006;21:826–33. doi:10.1007/s00384-005-0787-5.
   PubMed Web of Science ®Google Scholar
• Riegler G, Esposito I. Bristol scale stool form. A still valid help in medical practice and clinical research. Techniques in coloproctology. 2001;5:163–4. doi:10.1007/s101510100019.
   PubMedGoogle Scholar
• Frank L, Kleinman L, Farup C, Taylor L, Miner P. Psychometric validation of a constipation symptom assessment questionnaire. Scandinavian journal of gastroenterology. 1999;34:870–7. doi:10.1080/003655299750025327.
   PubMed Web of Science ®Google Scholar
• Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scandinavian journal of gastroenterology. 2005;40:540–51. doi:10.1080/00365520510012208.
   PubMed Web of Science ®Google Scholar
• Rentz A, Van Hanswijck De Jonge P, Leyendecker P, Hopp M. Observational, nonintervention, multicenter study for validation of the Bowel Function Index for constipation in European countries. Current medical research and opinion. 2011;27:35–44. doi:10.1185/03007995.2010.535270.
   PubMed Web of Science ®Google Scholar
• Ford AC, Quigley EM, Lacy BE, Lembo AJ, Saito YA, Schiller LR, Soffer EE, Spiegel BM, Moayyedi P. Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: Systematic review and meta-analysis. American journal of gastroenterology. 2014;109:1547–61. doi:10.1038/ajg.2014.202.
   PubMed Web of Science ®Google Scholar
• Miller LE, Zimmermann AK, Ouwehand AC. Contemporary meta-analysis of short-term probiotic consumption on gastrointestinal transit. World journal of gastroenterology. 2016;22:5122. doi:10.3748/wjg.v22.i21.5122.
   PubMed Web of Science ®Google Scholar
• Goossens D, Jonkers D, Stobberingh E, Bogaard Avd, Russel M, Stockbrugger R. Probiotics in gastroenterology: Indications and future perspectives. Scandinavian Journal of Gastroenterology-Supplements. 2003;38:15–6. doi:10.1080/00855920310002645.
   Google Scholar
• Ouwehand AC, Lagström H, Suomalainen T, Salminen S. Effect of probiotics on constipation, fecal azoreductase activity and fecal mucin content in the elderly. Annals of nutrition and metabolism. 2002;46:159–62. doi:10.1159/000063075.
   PubMed Web of Science ®Google Scholar
• Sanders ME. Summary of probiotic activities of Bifidobacterium lactis HN019. Journal of clinical gastroenterology. 2006;40:776–83. doi:10.1097/01.mcg.0000225576.73385.f0.
   PubMed Web of Science ®Google Scholar
• Waller PA, Gopal PK, Leyer GJ, Ouwehand AC, Reifer C, Stewart ME, Miller LE. Dose-response effect of Bifidobacterium lactis HN019 on whole gut transit time and functional gastrointestinal symptoms in adults. Scandinavian journal of gastroenterology. 2011;46:1057–64. doi:10.3109/00365521.2011.584895.
   PubMed Web of Science ®Google Scholar
• Dalziel JE, Anderson RC, Peters JS, Lynch AT, Spencer NJ, Dekker J, Roy NC. Promotility Action of the Probiotic Bifidobacterium lactis HN019 Extract Compared with Prucalopride in Isolated Rat Large Intestine. Frontiers in neuroscience. 2017;11. doi:10.3389/fnins.2017.00020.
   PubMed Web of Science ®Google Scholar
• Association WM. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Jama. 2013;310:2191. doi:10.1001/jama.2013.281053.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation Working Group. ICH harmonised tripartite guideline: Guideline for good clinical practice E6 (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1996;10:1–53.
   Google Scholar
• Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC medicine. 2010;8:1. doi:10.1186/1741-7015-8-18.
   PubMed Web of Science ®Google Scholar
• Ioannidis JP, Evans SJ, Gøtzsche PC, O'neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Annals of internal medicine. 2004;141:781–8. doi:10.7326/0003-4819-141-10-200411160-00009.
   PubMed Web of Science ®Google Scholar
• Ibarra A, Olli K, Ouwehand AC. Correcting for non-compliance when determining colonic transit time with radio-opaque markers. World Journal of Gastroenterology. 2017;23:740–2. doi:10.3748/wjg.v23.i4.740.
   PubMed Web of Science ®Google Scholar
• Hagströmer M, Oja P, Sjöström M. The International Physical Activity Questionnaire (IPAQ): A study of concurrent and construct validity. Public health nutrition. 2006;9:755–62. doi:10.1079/PHN2005898.
   PubMed Web of Science ®Google Scholar
• Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Safety. 1999;20:109–17. doi:10.2165/00002018-199920020-00002.
   PubMed Web of Science ®Google Scholar
• WHO. World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification System. Guidelines for ATC Classification. 1993:23–185.
   Google Scholar
• Miller LE, Ibarra A, Ouwehand AC, Zimmermann AK. Normative values for stool frequency and form using Rome III diagnostic criteria for functional constipation in adults: systematic review with meta-analysis. Annals of Gastroenterology. 2017;30:161–7.
   PubMed Web of Science ®Google Scholar
• Meier R, Beglinger C, Dederding J, MEYER‐WYSS B, Fumagalli M, Rowedder A, Turberg Y, Brignoli R. Influence of age, gender, hormonal status and smoking habits on colonic transit time. Neurogastroenterology & Motility. 1995;7:235–8. doi:10.1111/j.1365-2982.1995.tb00231.x.
   PubMed Web of Science ®Google Scholar
• Camilleri M, Thorne NK, Ringel Y, Hasler WL, Kuo B, Esfandyari T, Gupta A, Scott SM, McCallum RW, Parkman HP, et al. Wireless pH‐motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterology & Motility. 2010;22:874–e233. doi:10.1111/j.1365-2982.2010.01517.x.
   PubMed Web of Science ®Google Scholar
• Park SY, Park HB, Lee JM, Lee HJ, Park CH, Kim HS, Choi SK, Rew JS. Relevance of colonic gas analysis and transit study in patients with chronic constipation. Journal of neurogastroenterology and motility. 2015;21:433–9. doi:10.5056/jnm14109.
   PubMed Web of Science ®Google Scholar
• Polymeros D, Beintaris I, Gaglia A, Karamanolis G, Papanikolaou IS, Dimitriadis G, Triantafyllou K. Partially hydrolyzed guar gum accelerates colonic transit time and improves symptoms in adults with chronic constipation. Digestive diseases and sciences. 2014;59:2207–14. doi:10.1007/s10620-014-3135-1.
   PubMed Web of Science ®Google Scholar
• Fateh R, Iravani S, Frootan M, Rasouli M, Saadat S. Synbiotic preparation in men suffering from functional constipation: a randomised controlled trial. Swiss medical weekly. 2010;141:w13239–w.
   Web of Science ®Google Scholar
• Neri L, Conway PM, Basilisco G. Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation. Quality of Life Research. 2015;24:1597–605. doi:10.1007/s11136-014-0886-2.
   PubMed Web of Science ®Google Scholar
• Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, et al. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. American journal of gastroenterology. 2015;110:741–8. doi:10.1038/ajg.2015.115.
   PubMed Web of Science ®Google Scholar
• Abbott R, Ayres I, Hui E, Hui K-K. Effect of perineal self-acupressure on constipation: A randomized controlled trial. Journal of general internal medicine. 2015;30:434–9. doi:10.1007/s11606-014-3084-6.
   PubMedGoogle Scholar
• Da N, Wang X, Liu H, Xu X, Jin X, Chen C, Zhu D, Bai J, Zhang X, Zou Y, et al. The Effectiveness of Electroacupuncture for Functional Constipation: A Randomized, Controlled, Clinical Trial. Evidence-Based Complementary and Alternative Medicine. 2015; 2015:1–5. doi:10.1155/2015/670963.
   Web of Science ®Google Scholar
• Dupont C, Campagne A, Constant F. Efficacy and safety of a magnesium sulfate–rich natural mineral water for patients with functional constipation. Clinical Gastroenterology and Hepatology. 2014;12:1280–7. doi:10.1016/j.cgh.2013.12.005.
   PubMed Web of Science ®Google Scholar
• Saad RJ, Rao SS, Koch KL, Kuo B, Parkman HP, McCallum RW. Do Stool Form and Frequency Correlate With Whole-Gut and Colonic Transit? Results From a Multicenter Study in Constipated Individuals and Healthy Controls. American journal of gastroenterology. 2010;105:403–11. doi:10.1038/ajg.2009.612.
   PubMed Web of Science ®Google Scholar
• Heaton K, Radvan J, Cripps H, Mountford R, Braddon F, Hughes A. Defecation frequency and timing, and stool form in the general population: A prospective study. Gut. 1992;33:818–24. doi:10.1136/gut.33.6.818.
   PubMed Web of Science ®Google Scholar
• EFSA Panel on Dietetic Products Nutrition and Allergies (NDA). Scientific Opinion on the substantiation of a health claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency pursuant to Article 13.5 of Regulation (EC) No 1924/2006. EFSA Journal. 2015;13(1):3951–63. doi:10.2903/j.efsa.2015.3951. 2015.
   Google Scholar
• Micka A, Siepelmeyer A, Holz A, Theis S, Schön C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: A randomized, double-blind, placebo-controlled trial. International journal of food sciences and nutrition. 2017;68:82–9. doi:10.1080/09637486.2016.1212819.
   PubMed Web of Science ®Google Scholar
• de Gouveia Santos VLC, de Cássia Domansky R, Hanate C, Matos DS, Benvenuto CVC, Jorge JMN. Self-reported fecal incontinence in a community-dwelling, urban population in Southern Brazil. Journal of Wound Ostomy & Continence Nursing. 2014;41:77–83. doi:10.1097/01.WON.0000438018.83110.88.
   PubMed Web of Science ®Google Scholar
• Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. American journal of gastroenterology. 2011;106:120–9. doi:10.1038/ajg.2010.305.
   PubMed Web of Science ®Google Scholar
• Kamm MA, Mueller–Lissner S, Wald A, Richter E, Swallow R, Gessner U. Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clinical Gastroenterology and Hepatology. 2011;9:577–83. doi:10.1016/j.cgh.2011.03.026.
   PubMed Web of Science ®Google Scholar
• Kang D-W, DiBaise JK, Ilhan ZE, Crowell MD, Rideout JR, Caporaso JG, Rittmann BE, Krajmalnik-Brown R. Gut microbial and short-chain fatty acid profiles in adults with chronic constipation before and after treatment with lubiprostone. Anaerobe. 2015;33:33–41. doi:10.1016/j.anaerobe.2015.01.005.
   PubMed Web of Science ®Google Scholar
• Yeun Y, Lee J. Effect of a double-coated probiotic formulation on functional constipation in the elderly: A randomized, double blind, controlled study. Archives of pharmacal research. 2015;38:1345–50. doi:10.1007/s12272-014-0522-2.
   PubMed Web of Science ®Google Scholar
• Bian Z, Cheng C, Zhu L. Chinese herbal medicine for functional constipation: A randomised controlled trial. Hong Kong medical journal = Xianggang yi xue za zhi/Hong Kong Academy of Medicine. 2013;19:44–6.
   PubMedGoogle Scholar
• Bothe G, Coh A, Auinger A. Efficacy and safety of a natural mineral water rich in magnesium and sulphate for bowel function: A double-blind, randomized, placebo-controlled study. European Journal of Nutrition. 2015:1–9.
   Google Scholar
• Mueller-Lissner S, Kamm MA, Wald A, Hinkel U, Koehler U, Richter E, Bubeck J. Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of sodium picosulfate in patients with chronic constipation. American journal of gastroenterology. 2010;105:897–903. doi:10.1038/ajg.2010.41.
   PubMed Web of Science ®Google Scholar
• Waitzberg DL, Logullo LC, Bittencourt AF, Torrinhas RS, Shiroma GM, Paulino NP, Teixeira-da-Silva ML. Effect of synbiotic in constipated adult women–a randomized, double-blind, placebo-controlled study of clinical response. Clinical nutrition. 2013;32:27–33. doi:10.1016/j.clnu.2012.08.010.
   PubMed Web of Science ®Google Scholar
• Wong RK, Palsson OS, Turner MJ, Levy RL, Feld AD, Von Korff M, Whitehead WE. Inability of the Rome III criteria to distinguish functional constipation from constipation-subtype irritable bowel syndrome. American journal of gastroenterology. 2010;105:2228–34. doi:10.1038/ajg.2010.200.
   PubMed Web of Science ®Google Scholar
• Benjamin AT, Quinn JJ. Proofs that really count: The art of combinatorial proof. The Mathematical Association of America. 2003; 1:1–169. ISBN: 0-88385-333-7.
   Google Scholar