The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial

Abstract

Background Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy; however, in a lack of high-quality evidence of efficacy, no strain- and dose-specific probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the Bifidobacterium quadruple viable tablet in the treatment of IBS-D. Methods/design A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients who fulfill the eligibility criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the Bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency; the secondary outcome includes evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL, and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events, and concomitant medication will be taken into account for intervention safety assessment during the trial. Discussion This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the Bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotic intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis. Trial registration ChiCTR1800017721. Registered on 10 August 2018.

The Short-Term Efficacy of Bifidobacterium Quadruple Viable Tablet in Patients With Diarrhea-Predominant Irritable Bowel Syndrome: Potentially Mediated by Metabolism Rather Than Diversity Regulation

“…Secondary outcomes. The secondary outcomes including overall symptom relief, bowel frequency, bloating, urgency of defecation, QoL, depression score, anxiety score, and change of microbiota and fecal metabolites were assessed using the method described (19). Overall symptom relief and bloating were assessed by using 1-7 to represent different levels (1 represented complete remission/not at all, 7 represented the worst condition imaginable/unbearable).…”

“…We have published the methods used in this trial previously (19). There were no important changes in methods after trial commencement.…”

“…According to the method described in the protocol (19), it was assumed that the 4-week treatment response rate of the probiotics group was 50% and that of the placebo group was 30%. Based on α = 0.05 and β = 0.10, the minimized sample size would be 124 pairs.…”

“…There were not any changes to trial outcomes after the trial commenced. As described in the previous protocol, the primary outcome of this trial is the response rate (19). A patient is categorized as a responder if having improvement in both pain intensity and stool consistency.…”

Analisar o uso de cepas probióticas no tratamento da diarreia aguda

“…Várias cepas no intestino do hospedeiro apresentam efeito anti-inflamatório e moduladores do sistema imunológico (Xiao et al, 2020). Além de inibir certas bacterais patogenicas e elevar o peristaltismo intestinal, proporciona a normalidade e o equilíbrio da microbiota (Bai et al, 2020). E, melhora a consistência das fezes (Marques et al, 2020).…”