Adjunctive efficacy of Bifidobacterium animalis subsp. lactis XLTG11 in alleviating functional constipation in children

According to a recent study, the administration of XLTG11 at a dosage of 1 × 1010 CFU per day to children resulted in an elevation in fecal frequency, brought about favorable alterations in gut microbiota, and effectively regulated short-chain fatty acid (SCF) genes and genes associated with methane metabolism. This study’s results were published in the Brazilian Journal of Microbiology. 
In this double-blinded, randomized trial, eligible children were divided into two groups: the intervention group (n = 65) received conventional treatment with probiotics, and the control group (n = 66) received conventional treatment without probiotics. The primary outcome measure focused on fecal frequency. To predict gene family abundances based on 16S information, fecal gut microbiota analysis and PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) were utilized.
During the treatment period, there was a significant increase in the weekly frequency of feces in each group (F = 41.97, p < 0.001). The frequency of feces (times/week (t/w)) in the intervention group was notably higher compared to the control group post-intervention (3.69 ± 2.62 t/w versus 3.18 ± 1.43 t/w for the first week, 4.03 ± 2.54 t/w versus 2.89 ± 1.39 t/w for the second week, 3.74 ± 2.36 t/w versus. 2.94 ± 1.18 t/w for the third week, and 3.45 ± 1.98 versus 3.17 ± 1.41 t/w for the fourth week) (F = 7.60, p = 0.0067). The dominant species shifted to Bifidobacterium breve, Bifidobacterium longum, and Escherichia coli in the group that received the intervention. The genes associated with short-chain fatty acid metabolism were upregulated, while methane metabolism was downregulated.
The above study demonstrated that giving children XLTG11 at a daily dose of 1 × 1010 CFU resulted in more frequent bowel movements, brought about positive changes in gut microbiota, and effectively controlled SCFs genes and genes associated with methane metabolism.
 

Nomogram predicts cancer-specific survival for patients with primary gastrointestinal melanoma

According to a recent study, it was validated that nomogram can predict cancer-specific survival and develop a risk stratification system for patients with primary gastrointestinal melanoma. The findings of the study were published in The Turkish Journal of Gastroenterology.
Results from a database of 433 patients with primary gastrointestinal melanoma were included in the study after randomly dividing the participants into training and validation cohorts (8:2). The nomogram was constructed based on the risk factors identified in the multivariate Cox regression analysis. Based on the nomogram, a risk stratification system was developed. Time-dependent receiver operating characteristic, calibration curve, and decision curve analysis were performed.
All cases were randomly divided into either the training (n = 347, 80%) or validation cohort (n = 86, 20%). For all patients, the median cancer-specific survival (CSS) time was 18.0 months (95% CI: 14.7-21.3). The median CSS was 18.0 months (95% CI: 14.5-21.5) and 18.0 months (95% CI: 10.7-25.3) in the training and validation cohorts, respectively (log-rank test, P = .241).
It was found that CSS under the curves of the nomogram for 6-, 12-, and 18-month were 0.789, 0.757, and 0.726 for internal validation, and 0.796, 0.763, and 0.795 for the external validation. Furthermore, the patients were divided into 2 risk sub-groups to study the risk stratification, low-risk (point: 0-182) and high-risk (point: 183-333). The median CSS was 31.0 months (95% CI: 24.5-37.5) in the low-risk subgroup and 8.0 months (95% CI: 6.2-9.8) in the high-risk subgroup. The Kaplan-Meier analysis and the log-rank test demonstrated that the risk stratification was well-differentiated in patients with varying risks of cancer-specific survival.
Thus, it can be concluded that the nomogram prediction model may be practical for validation of cancer-specific survival and development of a risk stratification system in patients with primary gastrointestinal melanoma.
 

Safety and immunogenicity of the live-attenuated chikungunya virus vaccine candidate VLA1553

A recent study suggests that VLA1553 batches are both safe and immunogenic. This study’s findings were published in the Journal of travel medicine.

This was a phase 3, randomized, double-blinded, and focused on lot-to-lot consistency trial that included 408 healthy adults (aged 18-45 years). The primary endpoint of the study was to compare the geometric mean titre (GMT) ratios of chikungunya virus (CHIKV)-specific neutralizing antibodies between three different batches of VLA1553, 28 days after the administration of the vaccine. Additionally, secondary endpoints included assessing the immunogenicity and safety of the vaccine over a period of 6 months post-vaccination.

GMTs were similar among the batches that met the criteria for equivalence. The average GMT (measured by fifty percentage CHIKV micro plaque neutralization test; μPRNT50) reached 2643 at 28 days post-vaccination and dropped to 709 at 6 months post-vaccination. At 28 days post-vaccination, a high seroresponse rate (μPRNT50 titre ≥ 150 considered protective) was seen in 97.8% of participants, maintained at 96% at 6 months post vaccination. Following the administration of VLA1553 immunization, adverse events (AEs) were reported by 72.5% of the participants with no significant variations observed between the different batches. Generally, AEs were mild or moderate and resolved without any sequela, typically within 3 days.

Thus, it can be concluded that all three batches of VLA1553 were found to be safe and immunogenic. These findings emphasize the potential of VLA1553 as a vaccine for effectively preventing CHIKV disease in individuals residing in or visiting areas where the disease is prevalent.

Safety and efficacy of linaclotide in treating functional constipation in paediatric patients

According to a recent study, linaclotide has proven to be an effective and well-tolerated remedy for functional constipation in pediatric patients. This study’s findings were published in the journal, Lancet. Gastroenterology & hepatology.

In this double-blind, randomised,  placebo-controlled, phase 3 study, patients aged 6-17 years were randomly assigned to receive either oral linaclotide 72 μg [n=166] or placebo [n=164] once daily for 12 weeks. The study's primary efficacy endpoint was the change from baseline (CFB) in the frequency rate of spontaneous bowel movements (SBM) per week over a twelve-week period. The change from baseline in stool consistency during the treatment period was the secondary efficacy endpoint. Efficacy and safety were analyzed in all patients who received at least one dose of the study intervention.

The mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) with placebo and 1·16 SBMs per week (0·83) with linaclotide at baseline. This rate increased to 2·29 SBMs per week (1·99) with placebo and 3·41 SBMs per week (2·76) with linaclotide during the intervention. Patients treated with linaclotide demonstrated a significant increase in SBM frequency [least-squares mean (LSM) CFB 2·22 SBMs per week (SE 0·19)] compared to those on placebo [LSM CFB 1·05 SBMs per week (0·19)]. Additionally, linaclotide demonstrated a notable improvement in stool consistency compared to the placebo group [LSM CFB 1.11 (SE 0.08) versus 0.69 (0.08)]. Based on the above results, it can be concluded that linaclotide is an efficacious and well-tolerated treatment for functional constipation in paediatric patients.