Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study.

In the present study, the safety, tolerance and impact of 1×109 cfu Bacillus clausii CSI08, 1×109 cfu Bacillus megaterium MIT411 and a probiotic cocktail containing Bacillus subtilis DE111®, Bacillus megaterium MIT411, Bacillus coagulans CGI314, and Bacillus clausii CSI08 with a total count of 2.0×109 cfu administered daily were assessed as compared with a maltodextrin containing placebo control. A total of 98 study participants received daily doses for 45 days, followed by a washout period of 2 weeks. A questionnaire to capture the incidence and duration of upper respiratory tract, urinary tract and/or gastrointestinal complaints and a diary to capture stool regularity and consistency was kept daily to record compliance throughout the 45 days. Faecal and blood samples were collected for microbiological and haematological analysis at the start and end of the treatment period. The probiotic cocktail significantly decreased the incidence of loose stools throughout the entire study. The recorded respiratory, urinary and gastrointestinal symptoms, defecation frequency and other stool consistency were not influenced. No clinically relevant changes in blood parameters, such as liver and kidney function and no serious adverse events appeared during and after administration. There were no changes in symptoms including sadness, irritability, energy, appetite, tension, stress, sleep, cardiovascular events, aches and pains, and dizziness as determined by a mood questionnaire administered to participants at baseline and at the end of the treatment period. Similarly, the measured inflammatory cytokines, antioxidant levels, cholesterol, triglycerides, free amino acids or minerals remained unaffected. There were no negative changes in alpha or beta diversity of the microbiota with any of the treatment groups. These promising data suggest that these treatments were safe and well tolerated, and further work with larger cohorts are justified to determine the efficacy of these potential probiotics in select demographic groups. Trial registration number with clinicaltrials.gov at NCT04758845.

Inter-observer agreement of ultrasonographic measurement of alpha and beta angles and the final type classification based on the Graf method.

BACKGROUND: The aim of our study was to investigate the agreement of the assessment of hip ultrasonograms by different observers. METHODS: In the period from June 3rd to December 9th 2002, four different (by experience and field) groups of observers rated all first time sonograms obtained in our hospital. The results in terms of angle and type classification were compared. RESULTS: 158 ultrasonographic images were evaluated. The inter-observer agreement for the classification "normal" (type I) versus "abnormal" (types IIa+ to IV) varied from 83% to 90% with kappa coefficients which indicated moderate (kappa 0.55) to substantial (kappa 0.71) inter-observer agreement. For one pair of observers, a better agreement could be demonstrated for the assessment of immature hips than for mature ones. The deviation for the a-angle was 0 to 16 degrees with a standard deviation of 3.15 degrees (95% CI 2.95, 3.37), and for the b-angle 0 to 26 degrees with a standard deviation of 6.1 degrees (95% CI 5.7, 6.5). The intra-class correlation coefficient was estimated to be 0.72 and 0.34 for the alpha and beta angles respectively. If the hip was immature there was no increase in the discrepancy in assessment between observers. The least agreement existed between the less experienced and the most experienced. It has not been possible to make a statement on the discrepancy with regard to initial signs of instability or decentralization of the hip joints because of the small number of hips of this type. CONCLUSIONS: Although the spread in measured a- and b-angles is large, the inter-observer agreement for the classification showed good results. No disagreement occurred in the diagnosis of normal vs. dysplastic hips, so no severe cases have been missed. The experience and training of the investigators seemed to play an important role with regard to variability and agreement. The agreement in the assessment of immature hips was better than that of mature hips. Therefore, ultrasound examination of infant hips would appear to be a trustworthy screening method.

The mouse congenital polycystic kidney (cpk) locus maps within 1.3 cM of the chromosome 12 marker D12Nyu2.

The mouse congenital polycystic kidney (cpk) mutation causes bilateral cystic dilatation of the renal collecting tubules and leads to rapidly progressive renal insufficiency in affected homozygotes. The phenotype of the cpk/cpk mutants closely resembles that of human autosomal recessive polycystic kidney disease (ARPKD). Previously, we have reported that the cpk locus maps close to D12Nyu2 on Chromosome (Chr) 12. To determine the cpk map location more precisely, we have extended our previous studies using additional progeny and additional markers of proximal Chr 12. These recent studies position cpk within 1.3 cM of D12Nyu2, closely flanked by (Odc, D12Mit10) and (Tpo, D12Mit12). Our data support an ordered array of seven DNA markers that will provide reference points for building a physical map of the Chr 12 region centered on cpk. Moreover, these data establish that cpk lies within a linkage group that is conserved between mouse Chr 12 and human chr 2p24-2p25. This assignment to a region of homology will facilitate human linkage analyses to determine whether mouse cpk and human ARPKD are mutations of homologous genes.