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
The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria.
There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS.
This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.
Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group.
This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.
- 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
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International Journal of Colorectal Disease
Volume 28, Issue 3 , pp 349-358
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- Irritable bowel syndrome
- Randomised clinical trial
- Industry Sectors
- Author Affiliations
- 1. Chirurgia Generale e Geriatrica, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli Federico II, Via Pansini 5, 80131, Napoli, Italy
- 2. Gastroenterologia, IRCCS-Centro di Riferimento Oncologico della Basilicata, Via Padre Pio 1, Rionero in Vulture, 85028, Potenza, Italy
- 3. Gastroenterologia, Dipartimento di Medicina e Chirurgia, Università degli Studi di Salerno, Via S Allende, 84081, Baronissi, Salerno, Italy