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Original article

Vol. 141 No. 2930 (2011)

Synbiotic preparation in men suffering from functional constipation: a randomised controlled trial

  • R Fateh
  • S Iravani
  • M Frootan
  • S Saadat
  • MR Rasouli
Cite this as:
Swiss Med Wkly. 2011;141:w13239


BACKGROUND: Evaluating the effects of a commercially available synbiotic preparation (contains both prebiotic and probiotic elements) on functional constipation in males.

METHODS: In a randomised controlled trial, a total of 66 adult men with functional constipation were equally allocated to receive a synbiotic mixture or a placebo. The synbiotic mixture or placebo was given as capsules with the same shape and colour, and patients received the capsules twice a day for 4 weeks.

RESULTS: A total of 60 patients (31 in the synbiotic group) completed the study. At baseline evaluation, there was no significant difference between the mean stool frequency per week in synbiotic and placebo groups [mean difference of 0.11 times (95% CI: –0.31–0.55), = 0.58]. However, mean stool frequency increased significantly at weeks 2 [mean difference of 1.32 times (95% CI: 0.21–2.43)] and 4 [mean difference of 1.58 times (95% CI: 0.18–2.99)] in the synbiotic group compared with the placebo group (p = 0.02). A significant difference (p = 0.006) was found at weeks 2 [mean difference of 0.83 (95% CI: 0.20–1.45)] and 4 [mean difference of 0.91 (95% CI: 0.32–1.51)] between the synbiotic and placebo groups regarding the Bristol stool form score. No adverse effect was seen in the synbiotic group.

CONCLUSION: The results of this study indicated that this specific commercial product seemed to be effective in increasing stool frequency and improving consistency in this sample of males with functional constipation. However, further studies with longer follow ups, and including females and elderly patients are required to confirm the efficacy of this product for treatment of functional constipation.


  1. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004;99(4):750–9.
  2. Cheng C, Chan AO, Hui WM, Lam SK. Coping strategies, illness perception, anxiety and depression of patients with idiopathic constipation: a population-based study. Aliment Pharmacol Ther. 2003;18(3):319–26.
  3. Koloski NA, Talley NJ, Boyce PM. The impact of functional gastrointestinal disorders on quality of life. Am J Gastroenterol. 2000;95(1):67–71.
  4. Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993;38(9):1569–80.
  5. Dennison C, Prasad M, Lloyd A, Bhattacharyya SK, Dhawan R, Coyne K. The health-related quality of life and economic burden of constipation. Pharmacoeconomics. 2005;23(5):461–76.
  6. Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003;349(14):1360–8.
  7. Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007;25(5):599–608.
  8. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999;45(Suppl 2):II43–7.
  9. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006;130(5):1480–91.
  10. Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005;37(11):838–49.
  11. Borriello SP. Bacteria and gastrointestinal secretion and motility. Scand J Gastroenterol Suppl. 1984;93:115–21.
  12. Nakamura T, Nishida S, Mizutani M, Iino H. Effects of yogurt supplemented with brewer’s yeast cell wall on constipation and intestinal microflora in rats. J Nutr Sci Vitaminol (Tokyo). 2001;47(6):367–72.
  13. Ouwehand AC, Lagstrom H, Suomalainen T, Salminen S. Effect of probiotics on constipation, fecal azoreductase activity and fecal mucin content in the elderly. Ann Nutr Metab. 2002;46(3-4):159–62.
  14. Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998;39(3):237–8.
  15. Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995;125(6):1401–12.
  16. Madsen K. Probiotics in critically ill patients. J Clin Gastroenterol. 2008;42(Suppl 3 Pt 1):S116–8.
  17. Koebnick C, Wagner I, Leitzmann P, Stern U, Zunft HJ. Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation. Can J Gastroenterol. 2003;17(11):655–9.
  18. Mollenbrink M, Bruckschen E. Treatment of chronic constipation with physiologic Escherichia coli bacteria. Results of a clinical study of the effectiveness and tolerance of microbiological therapy with the E. coli Nissle 1917 strain (Mutaflor). Med Klin (Munich). 1994;89(11):587–93.
  19. Yang YX, He M, Hu G, Wei J, Pages P, Yang XH, et al. Effect of a fermented milk containing Bifidobacterium lactis DN-173010 on Chinese constipated women. World J Gastroenterol. 2008;14(40):6237–43.
  20. Chmielewska A, Szajewska H. Systematic review of randomised controlled trials: probiotics for functional constipation. World J Gastroenterol. 2010;16(1):69–75.
  21. Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006;130(5):1377–90.
  22. Frank L, Kleinman L, Farup C, Taylor L, Miner P, Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999;34(9):870–7.
  23. Adibi P, Behzad E, Pirzadeh S, Mohseni M. Bowel habit reference values and abnormalities in young Iranian healthy adults. Dig Dis Sci. 2007;52(8):1810–3.
  24. Boyle RJ, Robins-Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks? Am J Clin Nutr. 2006;83(6):1256–64; quiz 446–7.
  25. Picard C, Fioramonti J, Francois A, Robinson T, Neant F, Matuchansky C. Review article: bifidobacteria as probiotic agents – physiological effects and clinical benefits. Aliment Pharmacol Ther. 2005;22(6):495–512.
  26. Celik AF, Tomlin J, Read NW. The effect of oral vancomycin on chronic idiopathic constipation. Aliment Pharmacol Ther. 1995;9(1):63–8.
  27. Yajima T. Contractile effect of short-chain fatty acids on the isolated colon of the rat. J Physiol. 1985;368:667–78.
  28. Bu LN, Chang MH, Ni YH, Chen HL, Cheng CC. Lactobacillus casei rhamnosus Lcr35 in children with chronic constipation. Pediatr Int. 2007;49(4):485–90.
  29. Banaszkiewicz A, Szajewska H. Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children: a double-blind, placebo-controlled randomized trial. J Pediatr. 2005;146(3):364–9.
  30. Amenta M, Cascio MT, Di Fiore P, Venturini I. Diet and chronic constipation. Benefits of oral supplementation with symbiotic zir fos (Bifidobacterium longum W11 + FOS Actilight). Acta Biomed. 2006;77(3):157–62.
  31. Bekkali NL, Bongers ME, Van den Berg MM, Liem O, Benninga MA. The role of a probiotics mixture in the treatment of childhood constipation: a pilot study. Nutr J. 2007;6:17.
  32. Del Piano M, Morelli L, Strozzi GP, Allesina S, Barba M, Deidda F, et al. Probiotics: from research to consumer. Dig Liver Dis. 2006;38(Suppl 2):S248–55.