Skip to main content

Advertisement

SpringerLink
Log in

A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial

  • Original Article
  • Published:
Techniques in Coloproctology Aims and scope Submit manuscript

Abstract

Background

In recent years, the efficacy of probiotics has received considerable attention in the treatment for irritable bowel syndrome (IBS). In this regard, a symbiotic mixture (Probinul®) has shown beneficial effects. The aim of this study was to extend the previously published 4-week randomized, double-blinded, placebo-controlled study of this symbiotic mixture.

Methods

This is an open-label prospective, partially controlled, 6-month extension period pilot study in which patients continued to receive the symbiotic mixture (Group 1) or were switched from placebo to symbiotic mixture (Group 2) using cyclic administration (last 2 weeks/month). The primary endpoints were the overall satisfactory relief of bloating and flatulence (assessed as proportions of responders). The secondary endpoints were evaluation of the symptom severity scores (bloating, flatulence, pain and urgency) and bowel function scores (frequency, consistency and incomplete evacuation).

Results

Twenty-six IBS patients completed the 6-month extension period (13 patients in Group 1 and 13 patients in Group 2). In the per-protocol analysis, the proportions of responders across time were not significantly different in the groups but in Group 2, there was an increased percentage of responders for flatulence (p = 0.07). In addition, the score of flatulence was reduced significantly during the 6-month treatment period in Group 2 (p < 0.05), while no other significant differences were detected.

Conclusions

Treatment with this symbiotic mixture was associated with persistence of relief from flatulence or new reduction in flatulence in the present 6-month long extension study. These results need to be more comprehensively assessed in large, long-term, randomized, placebo-controlled studies.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA (1999) Functional bowel disorders and functional abdominal pain. Gut 45(Suppl 2):II43–II47

    PubMed Central  PubMed  Google Scholar 

  2. Brandt LJ, Chey WD, Foxx-Orenstein AE et al (2009) An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 104(Suppl 1):S1–S35

    PubMed  Google Scholar 

  3. Gibson GR, Probert HM, Loo JV, Rastall RA, Roberfroid MB (2004) Dietary modulation of the human colonic microbiota: updating the concept of prebiotics. Nutr Res Rev 17:259–275

    Article  PubMed  CAS  Google Scholar 

  4. Moayyedi P, Ford AC, Talley NJ et al (2010) The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut 59:325–332

    Article  PubMed  CAS  Google Scholar 

  5. Ritchie ML, Romanuk TN (2012) A meta-analysis of probiotic efficacy for gastrointestinal diseases. PloS One 7:e34938

    Google Scholar 

  6. Simren M, Barbara G, Flint HJ et al (2013) Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut 62:159–176

    Article  PubMed Central  PubMed  Google Scholar 

  7. O’Mahony L, McCarthy J, Kelly P et al (2005) Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 128:541–551

    Article  PubMed  Google Scholar 

  8. Ohman L, Simren M (2013) Intestinal microbiota and its role in irritable bowel syndrome (IBS). Curr Gastroenterol Rep 15:323

    Google Scholar 

  9. Cappello C, Tremolaterra F, Pascariello A, Ciacci C, Iovino P (2013) A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int J Color Dis 28:349–358

    Article  Google Scholar 

  10. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC (2006) Functional bowel disorders. Gastroenterology 130:1480–1491

    Article  PubMed  Google Scholar 

  11. Lewis SJ, Heaton KW (1997) Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 32:920–924

    Article  PubMed  CAS  Google Scholar 

  12. Heaton KW, Radvan J, Cripps H, Mountford RA, Braddon FE, Hughes AO (1992) Defecation frequency and timing, and stool form in the general population: a prospective study. Gut 33:818–824

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  13. Heaton KW, O’Donnell LJ (1994) An office guide to whole-gut transit time. Patients’ recollection of their stool form. J Clin Gastroenterol 19:28–30

    Article  PubMed  CAS  Google Scholar 

  14. Heaton KW, Ghosh S, Braddon FE (1991) How bad are the symptoms and bowel dysfunction of patients with the irritable bowel syndrome? A prospective, controlled study with emphasis on stool form. Gut 32:73–79

    Article  PubMed Central  PubMed  CAS  Google Scholar 

  15. Ringel Y, Williams RE, Kalilani L, Cook SF (2009) Prevalence, characteristics, and impact of bloating symptoms in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol 7:68–72

    Article  PubMed  Google Scholar 

  16. Caldarella MP, Serra J, Azpiroz F, Malagelada JR (2002) Prokinetic effects in patients with intestinal gas retention. Gastroenterology 122:1748–1755

    Article  PubMed  Google Scholar 

  17. Coleski R, Owyang C, Hasler WL (2006) Modulation of intestinal gas dynamics in healthy human volunteers by the 5-HT receptor agonist tegaserod. Am J Gastroenterol 101:1858–1865

    Article  PubMed  CAS  Google Scholar 

  18. Villoria A, Serra J, Azpiroz F, Malagelada JR (2006) Physical activity and intestinal gas clearance in patients with bloating. Am J Gastroenterol 101:2552–2557

    Article  PubMed  Google Scholar 

  19. Tremolaterra F, Pascariello A, Gallotta S, Ciacci C, Iovino P (2013) Colonic gas transit in patients with bloating: the effect of an electromechanical stimulator of the abdominal wall. Tech Coloproctol 17:405–410

    Article  PubMed  CAS  Google Scholar 

  20. Whorwell PJ, Altringer L, Morel J et al (2006) Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 101:1581–1590

    Article  PubMed  Google Scholar 

  21. Kim HJ, Camilleri M, McKinzie S et al (2003) A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea- predominant irritable bowel syndrome. Aliment Pharmacol Ther 17:895–904

    Article  PubMed  CAS  Google Scholar 

  22. Kim HJ, Vazquez Roque MI, Camilleri M et al (2005) A randomized controlled trial of a probiotic combination VSL# 3 and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil 17:687–696

    Article  PubMed  CAS  Google Scholar 

  23. Ringel-Kulka T, Palsson OS, Maier D et al (2011) Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol 45:518–525

    Article  PubMed  Google Scholar 

  24. Spiller R (2008) Review article: probiotics and prebiotics in irritable bowel syndrome. Aliment Pharmacol Ther 28:385–396

    Article  PubMed  CAS  Google Scholar 

  25. Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS (2009) The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol 104:1033–1049

    Article  PubMed  CAS  Google Scholar 

  26. Schrezenmeir J, de Vrese M (2001) Probiotics, prebiotics, and synbiotics–approaching a definition. Am J Clin Nutr 73:S361–S364

    Google Scholar 

  27. Ng SC, Hart AL, Kamm MA, Stagg AJ, Knight SC (2009) Mechanisms of action of probiotics: recent advances. Inflamm Bowel Dis 15:300–310

    Article  PubMed  CAS  Google Scholar 

  28. Forsythe P, Bienenstock J (2010) Immunomodulation by commensal and probiotic bacteria. Immunol Invest 39:429–448

    Article  PubMed  CAS  Google Scholar 

  29. Ohland CL, Macnaughton WK (2010) Probiotic bacteria and intestinal epithelial barrier function. Am J Physiol Gastrointest Liver Physiol 298:G807–G819

    Article  PubMed  CAS  Google Scholar 

  30. Poulton EC, Freeman PR (1966) Unwanted asymmetrical transfer effects with balanced experimental designs. Psychol Bull 66:1–8

    Article  PubMed  CAS  Google Scholar 

  31. Cook TDCT (1979) Quasi-experimentation: design & analysis issues for field studies. Houghton Mifflin Co, Boston

    Google Scholar 

  32. Bramwell ATBAJ, Morrissey SJ (1992) Repeated-measures analysis: issue and options. Int J Ind Ergon 10:185–197

    Article  Google Scholar 

  33. Rosenthal R (1966) Experimental effects in behavioral research. Appleton-Century-Crofts, New York

    Google Scholar 

  34. Hrobjartsson A (2002) What are the main methodological problems in the estimation of placebo effects? J Clin Epidemiol 55:430–435

    Article  PubMed  Google Scholar 

Download references

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Gastrointestinal Unit, Department of Medicine and Surgery, University of Salerno, Via S Allende, 84081, Baronissi, Salerno, Italy

    C. Bucci, S. Gallotta, A. Fortunato, C. Ciacci & P. Iovino

  2. Centro di Riferimento Oncologico di Basilicata, IRCCS, Rionero in Vulture, PZ, Italy

    F. Tremolaterra

  3. General and Geriatric Surgery Department, Federico II University of Naples, Via Pansini 5, 80131, Naples, Italy

    C. Cappello

Authors
  1. C. Bucci
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. F. Tremolaterra
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. S. Gallotta
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. A. Fortunato
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. C. Cappello
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. C. Ciacci
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. P. Iovino
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to P. Iovino.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bucci, C., Tremolaterra, F., Gallotta, S. et al. A pilot study on the effect of a symbiotic mixture in irritable bowel syndrome: an open-label, partially controlled, 6-month extension of a previously published trial. Tech Coloproctol 18, 345–353 (2014). https://doi.org/10.1007/s10151-013-1055-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10151-013-1055-2

Keywords

Search

Navigation