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Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study.
Aliment Pharmacol Ther 2011; 33(10):1123-32AP

Abstract

BACKGROUND

Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (IBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest.

AIM

To assess the efficacy of Bifidobacterium bifidum MIMBb75 in IBS.

METHODS

A total of 122 patients were randomised to receive either placebo (N=62) or MIMBb75 (N=60) once a day for 4 weeks. The severity of IBS symptoms was recorded daily on a 7-point Likert scale.

RESULTS

MIMBb75 significantly reduced the global assessment of IBS symptoms by -0.88 points (95% CI: -1.07; -0.69) when compared with only -0.16 (95% CI: -0.32; 0.00) points in the placebo group (P<0.0001). MIMBb75 also significantly improved the IBS symptoms pain/discomfort, distension/bloating, urgency and digestive disorder. The evaluation of the SF12 sum scores showed a significant gain in quality of life within the bifidobacteria group. Furthermore, adequate relief was reported by 47% of the patients in the bifidobacteria and only by 11% of the patients in the placebo group (P<0.0001). Overall responder rates were 57% in the bifidobacteria group but only 21% in the placebo group (P=0.0001). MIMBb75 was well tolerated and adverse events were not different from placebo.

CONCLUSIONS

Bifidobacterium bifidum MIMBb75 effectively alleviates global IBS and improves IBS symptoms simultaneously with an improvement of quality of life. Considering the high efficacy of MIMBb75 in IBS along with the good side-effect profile, MIMBb75 is a promising candidate for IBS therapy.

Authors+Show Affiliations

Department of Food Science and Microbiology, Università degli Studi di Milano,Via Celoria 2, Milan, Italy. simone.guglielmetti@unimi.itNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21418261

Citation

Guglielmetti, S, et al. "Randomised Clinical Trial: Bifidobacterium Bifidum MIMBb75 Significantly Alleviates Irritable Bowel Syndrome and Improves Quality of Life--a Double-blind, Placebo-controlled Study." Alimentary Pharmacology & Therapeutics, vol. 33, no. 10, 2011, pp. 1123-32.
Guglielmetti S, Mora D, Gschwender M, et al. Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011;33(10):1123-32.
Guglielmetti, S., Mora, D., Gschwender, M., & Popp, K. (2011). Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study. Alimentary Pharmacology & Therapeutics, 33(10), pp. 1123-32. doi:10.1111/j.1365-2036.2011.04633.x.
Guglielmetti S, et al. Randomised Clinical Trial: Bifidobacterium Bifidum MIMBb75 Significantly Alleviates Irritable Bowel Syndrome and Improves Quality of Life--a Double-blind, Placebo-controlled Study. Aliment Pharmacol Ther. 2011;33(10):1123-32. PubMed PMID: 21418261.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study. AU - Guglielmetti,S, AU - Mora,D, AU - Gschwender,M, AU - Popp,K, Y1 - 2011/03/21/ PY - 2011/3/23/entrez PY - 2011/3/23/pubmed PY - 2011/12/13/medline SP - 1123 EP - 32 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 33 IS - 10 N2 - BACKGROUND: Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (IBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest. AIM: To assess the efficacy of Bifidobacterium bifidum MIMBb75 in IBS. METHODS: A total of 122 patients were randomised to receive either placebo (N=62) or MIMBb75 (N=60) once a day for 4 weeks. The severity of IBS symptoms was recorded daily on a 7-point Likert scale. RESULTS: MIMBb75 significantly reduced the global assessment of IBS symptoms by -0.88 points (95% CI: -1.07; -0.69) when compared with only -0.16 (95% CI: -0.32; 0.00) points in the placebo group (P<0.0001). MIMBb75 also significantly improved the IBS symptoms pain/discomfort, distension/bloating, urgency and digestive disorder. The evaluation of the SF12 sum scores showed a significant gain in quality of life within the bifidobacteria group. Furthermore, adequate relief was reported by 47% of the patients in the bifidobacteria and only by 11% of the patients in the placebo group (P<0.0001). Overall responder rates were 57% in the bifidobacteria group but only 21% in the placebo group (P=0.0001). MIMBb75 was well tolerated and adverse events were not different from placebo. CONCLUSIONS: Bifidobacterium bifidum MIMBb75 effectively alleviates global IBS and improves IBS symptoms simultaneously with an improvement of quality of life. Considering the high efficacy of MIMBb75 in IBS along with the good side-effect profile, MIMBb75 is a promising candidate for IBS therapy. SN - 1365-2036 UR - https://www.unboundmedicine.com/medline/citation/21418261/Randomised_clinical_trial:_Bifidobacterium_bifidum_MIMBb75_significantly_alleviates_irritable_bowel_syndrome_and_improves_quality_of_life__a_double_blind_placebo_controlled_study_ L2 - https://doi.org/10.1111/j.1365-2036.2011.04633.x DB - PRIME DP - Unbound Medicine ER -