A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome.

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].

Detection of hepatitis E virus RNA and genotype in Bangladesh.

BACKGROUND/AIMS: Hepatitis E virus (HEV) in Bangladesh has not been adequately documented. We report HEV RNA and genotype detection in Bangladesh. METHODS: In total, 82 samples were used; 36 sporadic acute hepatitis (AH), 12 fulminant hepatitis (FH), 14 chronic liver disease (CLD) and 20 from an apparently healthy population (HP) positive for both immunoglobulin (Ig) M and IgG specific anti-HEV antibodies (anti-HEV). The male/female ratio was 61/21, ages 12-67 (mean 30.4) years. RNA was extracted, transcribed to cDNA and amplified in nt 6345-6490 (ORF2) of HEV. Nucleic and amino acid sequences were determined. Homology comparison between Bangladesh clones and other representative HEV clones and phylogenetic tree analyses were done. Relations between HEV RNA-positivity and clinical factors were analyzed. RESULTS: HEV RNA was positive in 9/36 (25.0%) of AH cases, 4/12 (33.3%) FH, 3/14 (21.4%) CLD and 0/20 (0%) HP samples; total 16/82 (19.5%). Four factors correlated significantly with HEV RNA-positivity (Mann-Whitney U test); alanine aminotransferase (ALT) (P = 0.0229), aspartate aminotransferase (AST) (P = 0.0448), and titers of IgG (P = 0.0208) and IgM (P = 0.0095) specific anti-HEV. The 16 HEV clones were divided mainly into two groups, A and B, including six different cDNA sub-groups. CONCLUSION: HEV RNA was found in sporadic AH and FH and sub-clinical CLD cases, but not in HP. HEV RNA-positivity was significantly related to values of ALT and AST and titers of IgG and IgM specific anti-HEV, with IgM specific anti-HEV showing the most significant relationship. All clones were genotype I, which is prevalent in South Asia.

Hepatitis e virus infection in fulminant hepatitis patients and an apparently healthy population in Bangladesh.

This is the first study comparing hepatitis E virus (HEV) infection in Bangladesh in fulminant hepatitis (FH) patients presumed to have a viral cause and in the apparently healthy population. Sera from 22 FH patients were analyzed for antibodies to hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C and D viruses, and HEV and for hepatitis B surface antigen (HBsAg). Anti-HEV immunoglobulin M (IgM) was detected in the sera of 63.6% of patients, whereas 35.7% were positive for HBsAg. A high prevalence of HEV infection (83.3%) was noted in the HBV carriers. Serum samples from 273 apparently healthy individuals were tested for antibodies to HAV and HEV. Anti-HEV IgM was detected in 7.3% of the samples. The seroprevalence of HAV differed from that of HEV in the same population because all samples were negative for anti-HAV IgM. These data indicate that HEV infection is highly endemic in Bangladesh.