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A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome.
BMC Gastroenterol 2018; 18(1):71BG

Abstract

BACKGROUND

Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.

METHODS

In this double-blind trial 400 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic Bio-Kult® (14 different bacterial strains) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.

RESULTS

Probiotic treatment significantly improved the severity of abdominal pain in patients with IBS-D. A 69% reduction for probiotic versus 47% for placebo (p < 0.001) equates to a 145 point reduction on the IBS-severity scoring system (IBS-SSS). The proportion of patients who rated their symptoms as moderate-to-severe was reduced from 100% at baseline to 14% for the multi-strain probiotic at follow-up (month 5) versus 48% for placebo (p < 0.001). Also, the number of bowel motions per day from month 2 onwards was significantly reduced in the probiotic group compared with the placebo group (p < 0.05). In addition to relieving symptoms, the probiotic markedly improved all dimensions of quality of life in the 34-item IBS-Quality of Life (IBS-QoL) questionnaire. No serious adverse events were reported.

CONCLUSIONS

The multi-strain probiotic was associated with significant improvement in symptoms in patients with IBS-D and was well-tolerated. These results suggest that probiotics confer a benefit in IBS-D patients which deserves further investigation.

TRIAL REGISTRATION

[Clinicaltrials.gov NCT03251625 ; retrospectively registered on August 9, 2017].

Authors+Show Affiliations

Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. s.md.ishaque@gmail.com.Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29801486

Citation

Ishaque, Shamsuddin M., et al. "A Randomized Placebo-controlled Clinical Trial of a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome." BMC Gastroenterology, vol. 18, no. 1, 2018, p. 71.
Ishaque SM, Khosruzzaman SM, Ahmed DS, et al. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol. 2018;18(1):71.
Ishaque, S. M., Khosruzzaman, S. M., Ahmed, D. S., & Sah, M. P. (2018). A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterology, 18(1), p. 71. doi:10.1186/s12876-018-0788-9.
Ishaque SM, et al. A Randomized Placebo-controlled Clinical Trial of a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome. BMC Gastroenterol. 2018 May 25;18(1):71. PubMed PMID: 29801486.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome. AU - Ishaque,Shamsuddin M, AU - Khosruzzaman,S M, AU - Ahmed,Dewan Saifuddin, AU - Sah,Mukesh Prasad, Y1 - 2018/05/25/ PY - 2018/01/26/received PY - 2018/04/26/accepted PY - 2018/5/27/entrez PY - 2018/5/29/pubmed PY - 2018/8/31/medline KW - BioKult KW - Diarrhea KW - Gastrointestinal well-being KW - IBS KW - Multi-strain probiotic KW - Probiotic KW - Quality of life KW - Randomized controlled trial SP - 71 EP - 71 JF - BMC gastroenterology JO - BMC Gastroenterol VL - 18 IS - 1 N2 - BACKGROUND: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms. METHODS: In this double-blind trial 400 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic Bio-Kult® (14 different bacterial strains) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure. RESULTS: Probiotic treatment significantly improved the severity of abdominal pain in patients with IBS-D. A 69% reduction for probiotic versus 47% for placebo (p < 0.001) equates to a 145 point reduction on the IBS-severity scoring system (IBS-SSS). The proportion of patients who rated their symptoms as moderate-to-severe was reduced from 100% at baseline to 14% for the multi-strain probiotic at follow-up (month 5) versus 48% for placebo (p < 0.001). Also, the number of bowel motions per day from month 2 onwards was significantly reduced in the probiotic group compared with the placebo group (p < 0.05). In addition to relieving symptoms, the probiotic markedly improved all dimensions of quality of life in the 34-item IBS-Quality of Life (IBS-QoL) questionnaire. No serious adverse events were reported. CONCLUSIONS: The multi-strain probiotic was associated with significant improvement in symptoms in patients with IBS-D and was well-tolerated. These results suggest that probiotics confer a benefit in IBS-D patients which deserves further investigation. TRIAL REGISTRATION: [Clinicaltrials.gov NCT03251625 ; retrospectively registered on August 9, 2017]. SN - 1471-230X UR - https://www.unboundmedicine.com/medline/citation/29801486/A_randomized_placebo_controlled_clinical_trial_of_a_multi_strain_probiotic_formulation__Bio_Kult®__in_the_management_of_diarrhea_predominant_irritable_bowel_syndrome_ L2 - https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-018-0788-9 DB - PRIME DP - Unbound Medicine ER -