medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2018-14-98-108medsovet-2659Research ArticleПрактика/ИсследованиеPractice/ResearchРандомизированное плацебо-контролируемое клиническое исследование мультипробиотика Bio-Kult® при лечении синдрома раздраженного кишечника с преобладанием диареиA randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrheapredominant irritable bowel syndromeIshaqueM.Sh.IshaqueM.Sh.

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Dhaka

KhosruzzamanS.M.KhosruzzamanS.M.

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Dhaka

AhmedD.S.AhmedD.S.

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Dhaka

SahM.P.SahM.P.

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Dhaka

Bangabandhu Sheikh Mujib Medical UniversityБангладешBangabandhu Sheikh Mujib Medical UniversityBangladesh20181010201801498108Copyright © Ishaque M., Khosruzzaman S., Ahmed D., Sah M., 20182018Ishaque M., Khosruzzaman S., Ahmed D., Sah M.Ishaque M., Khosruzzaman S., Ahmed D., Sah M.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/2659Справочная информация

Справочная информация: накопление доказательств подтверждает мнение о том, что дисбаланс кишечных бактерий способствует СРК и что увеличение массы полезных видов может уменьшить количество патогенных бактерий и помочь облегчить симптомы заболевания.

Методы

Методы: в данном двойном слепом исследовании 400 взрослых пациентов с клинически выраженным СРК с диареей (СРК-Д) от умеренной до тяжелой степени были рандомизированы для лечения с использованием мультипробиотика Bio-Kult® (14 различных бактериальных штаммов) или плацебо в течение 16 недель. Первичным критерием эффективности было изменение степени тяжести и частоты абдоминальной боли.

Результаты

Результаты: лечение пробиотиком значительно улучшило степень тяжесть боли в животе у пациентов с СРК-Д. Уменьшение боли на 69% для пробиотика в сравнении с 47% для плацебо (р < 0,001) соответствует 145-кратному снижению по системе оценки тяжести СРК-СОТ (СРК-СОТ). Доля пациентов, которые определили степень своих симптомов от умеренной до тяжелой, была снижена со 100% на исходном уровне до 14% для группы мультипробиотика при последующем наблюдении (5-й месяц) в сравнении с 48% для группы плацебо (р < 0,001). Кроме того, количество дефекаций в день со 2-го месяца было значительно меньше в группе мультибиотика по сравнению с группой плацебо (p < 0,05). Помимо облегчения симптомов, пробиотик заметно улучшил все параметры качества жизни согласно опроснику СРК-качество жизни (СРК-КЖ) из 34 пунктов. О серьезных нежелательных явлениях не сообщалось.

Выводы

Выводы. Применение мультипробиотика с несколькими штаммами приводит к значительным улучшениям симптомов у пациентов с СРК-Д и хорошо переносится. Эти результаты дают основание полагать, что пробиотики приносят пользу пациентам с СРК-Д и заслуживают дальнейшего изучения. Регистрация исследования: [Clinicaltrials.gov NCT03251625; ретроспективно зарегистрировано 9 августа 2017 г.]. 

Background

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

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

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

Conclusions: The multi-strain probiotic was associated with significant improvement in symptoms in patients with IBSD 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]. 

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The authors declare that there are no conflicts of interest present.