Background: Antibiotics alone are often insufficient to treat recurrent C. difficile infection (rCDI) because they have no activity against C. difficile spores that germinate within a disrupted microbiome. SER-109, an investigational, oral, microbiome therapeutic comprised of purified Firmicutes spores, was designed to reduce rCDI through microbiome repair. We report an integrated efficacy analysis through week 24 for SER-109 from phase 3 studies, ECOSPOR III and ECOSPOR IV. Methods: ECOSPOR III was a randomized, placebo-controlled phase 3 trial conducted at 56 US or Canadian sites that included 182 participants with ≥2 CDI recurrences, confirmed via toxin EIA testing. Participants were stratified by age (<65 years or ≥65 years) and antibiotic regimen (vancomycin, fidaxomicin) and were randomized 1:1 to placebo or SER-109 groups. ECOSPOR IV was an open-label, single-arm study conducted at 72 US or Canadian sites including 263 participants with rCDI enrolled in 2 cohorts: (1) rollover participants from ECOSPOR III who experienced on-study recurrence diagnosed by toxin EIA (n = 29) and (2) participants with ≥1 CDI recurrence (diagnosed by PCR or toxin EIA), inclusive of the current episode (n = 234). In both studies, the investigational product was administered orally as 4 capsules over 3 consecutive days following symptom resolution after standard-of-care antibiotics. The primary efficacy end point was rCDI (recurrent toxin-positive diarrhea requiring treatment) through week 8. Other end points included CDI recurrence rates and safety through 24 weeks. Results: These 349 participants received at least 1 dose of SER-109 in ECOSPOR III or ECOSPOR IV (mean age 64.2; 68.8% female). Overall, 77 participants (22.1%) enrolled with their first CDI recurrence. Four participants received blinded SER-109 in ECOSPOR III followed by a second dose of open-label SER-109 in ECOSPOR IV. Overall, the proportion of participants who received any dose of SER-109 with rCDI at week 8 was 9.5% (33 of 349; 95% CI, 6.6 %–13.0%), and the CDI recurrence rate remained low through 24 weeks (15.2%, 53 of 349; 95% CI, 11.6%–19.4%), corresponding to sustained clinical response rates of 90.5% (95% CI, 87.0%–93.4%) and 84.8% (95% CI, 80.6%–88.4%), respectively (Fig. 1). Most rollover participants (25 of 29, 86.2%) were from the placebo arm; 13.8% had rCDI by week 8. Conclusions: In this integrated analysis, the rates of rCDI were low and durable in participants who received the investigational microbiome therapeutic SER-109, with sustained clinical response rates of 90.5% and 84.8% at weeks 8 and 24, respectively. These data further support the potential benefit of microbiome repair with SER-109 following antibiotics for rCDI to prevent recurrence in high-risk patients.

Financial support: This study was funded by Seres Therapeutics.

Disclosure: None

Incorporating the dominant male sterile gene, Ms44, in new maize varieties results in 50% non-pollen producing (FNP) varieties. This makes the varieties more nitrogen efficient and increases yield directly by an average of 200 kg ha−1 across yield levels. However, as half of the plants do not shed pollen, the presence of Ms44 in an FNP variety is clearly visible. This technology can improve food production and security in the African maize-based agri-food systems, but only if accepted by farmers. Farmers were therefore invited to 11 on-farm, researcher managed trial sites of FNP varieties in Kenya over 2 years. They were asked to identify the traits they find important in evaluating maize varieties and to score the FNP varieties, as well as their conventional counterparts, on these criteria (including yield, resistance to pests, and cob size) and overall, using a five-point hedonic scale. In total, 2,697 farmers participated, of which 62% were women. Farmers mentioned many traits they find important, especially yield and related traits, early maturity, and drought resistance, but also tassel and pollen formation. In 2017, mid-season, participants scored FNP varieties lower than conventional varieties on tassel and pollen formation, indicating that farmers could distinguish the trait. FNP varieties still received higher scores for yield and overall evaluation. In mid-season 2018, participants no longer scored FNP varieties lower for pollen formation as they now understood the technology. In both years, at the end-season evaluation, scores for tassel formation were not different, but participants scored FNP varieties higher for yield and overall. We conclude that farmers recognized the FNP trait but did not mind it as they clearly favored its yield advantage. The FNP technology, therefore, has high potential not only to increase maize yields, food production, and food security in the agricultural systems of Africa but also to increase varietal turnover and the adoption of new, high-yielding, climate-smart maize hybrids.

The occurrence of species in both polar regions (bipolarity) is a common phenomenon in the Antarctic flora. Considering the high morphological variation in polar regions due to extreme conditions, the use of molecular tools is indispensable for testing whether Arctic and Antarctic populations indeed belong to the same species. However, few phylogeographic studies of bipolar bryophytes have been conducted so far, especially when comparing molecular and morphological variation. Here, we assess the bipolarity and intraspecific variation of Roaldia revoluta, a strictly bipolar species of pleurocarpous mosses. Phylogenetic analyses based on ITS sequences clearly resolve R. revoluta as monophyletic and confirm its bipolar distribution pattern. Low intraspecific molecular variation in the markers ITS/26S and rpl16 was observed, and most specimens from both polar regions belong to a single haplotype, making it difficult to infer the origin and dispersal routes between both polar regions of R. revoluta. Morphometric analysis furthermore suggests that there are no significant morphological differences among populations from both polar regions and that morphological variation is mainly influenced by local environmental conditions. Our data do not unequivocally support the recent separation of the former intraspecific taxon Hypnum revolutum var. dolomiticum at the species level as Roaldia dolomitica.

Fast drying (~60 min) is useful for optimizing production processes by increasing productivity and reducing costs and environmental impacts, especially in red ceramic industries in Brazil. However, suitable clays are necessary and, currently, studies focused on the plastic behaviour of clays with compositions suitable for extrusion, especially for fast drying, are scarce. Therefore, in this study, three different clays from the same mineral deposit were studied for producing clay-based structural products via fast drying. The clays were characterized according to their chemical, mineralogical and thermal properties, particle size, cation-exchange capacity, specific surface area and open pore volume distribution. Ten formulations were developed using a simplex-centroid mixture design of experiments and their plasticity index (PI) values were determined. The response surfaces of the formulations were evaluated according to their PI, while the formation characteristics were determined according to their extrusion workability factor values. Formulations F5 (50.0 wt.% yellow clay and 50.0 wt.% green clay) and F8 (66.6 wt.% yellow clay, 16.7 wt.% grey clay and 16.7 wt.% green clay; PI = 15.5–16.6%) displayed optimal extrusion properties, followed by formulations F7 (33.3 wt.% yellow clay, 33.3 wt.% grey clay and 33.3 wt.% green clay) and F10 (16.7 wt.% yellow clay, 16.7 wt.% grey clay and 66.6 wt.% green clay; PI = 13.8–14.2%), which are within acceptable extrusion index values. Thus, the chosen formulations have significant potential for use in the manufacture of fast-drying red ceramics.