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Effectiveness of a balanced nine-strain synbiotic in primary-care irritable bowel syndrome patients-A multi-center, randomized, double-blind, placebo-controlled trial

Irritable bowel syndrome (IBS) is a common and chronic functional gastrointestinal disorder characterized by recurrent abdominal pain, bloating, and changes in stool form and frequency that negatively impact the patient’s quality of life and work productivity. IBS is multifactorial, with gut microbiota dysbiosis playing a role as IBS patients express a different bacterial composition than their healthy counterparts. This randomized, double-blinded, placebo-controlled trial investigated the effects of a multi-strain synbiotic in patients with moderate to severe IBS. Two hundred and one adult IBS patients randomly received either one capsule daily of the synbiotic (63 mg of fructooligosaccharides (FOS) and 4.5 × 109 of Lactobacillus helveticus SP 27, Lacticaseibacillus rhamnosus Lr-32, Lacticaseibacillus casei Lc-11, Lactiplantibacillus plantarum Lp-115, Lactococcus lactis Ll-23, Bifidobacterium longum Bl-05, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-02, and Streptococcus thermophilus St-21) or placebo (maize starch) for 12 weeks. The primary endpoints were the severity of IBS symptoms (IBS-SSS) and improvement of IBS global symptoms (IBS-GIS). The secondary endpoints were adequate relief (IBS-AR scale), stool form type (Bristol Stool Form Scale), bowel movements, severity of abdominal pain and bloating, stool pressure, and feeling of incomplete stool evacuation. Significant improvement was reported in the IBS-SSS and IBS-GIS scores in the synbiotic group compared to placebo. At the end of treatment, 70% of patients in the synbiotic group achieved adequate relief and reported favorably differentiated secondary endpoints compared to the placebo. Two patients in the synbiotic group reported headaches as a transient adverse event. Overall, synbiotics may be effective in improving IBS symptoms and be well-tolerated.

Key takeaways:

  • IBS is a multi-factorial condition with environmental, inherited, and psychological factors contributing to disease manifestation.
  • Synbiotics may benefit IBS patients with gut microbiota dysbiosis as a contributing factor in the disease.
  • IBS patients reported significant improvements in IBS-SSS and IBS-GIS scores, with 70% of participants reporting adequate symptom relief after synbiotic intervention.
  • This study indicates the well-tolerability and efficacy of synbiotics in improving IBS symptoms.

Access to the study: https://pubmed.ncbi.nlm.nih.gov/38794741/

Reference: Sommermeyer, H., Chmielowiec, K., Bernatek, M., Olszewski, P., Kopczynski, J., & Piątek, J. (2024). Effectiveness of a Balanced Nine-Strain Synbiotic in Primary-Care Irritable Bowel Syndrome Patients-A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients, 16(10), 1503. https://doi.org/10.3390/nu16101503

 

Efficacy and safety of a synbiotic infant formula for the prevention of respiratory and gastrointestinal infections: a randomized controlled trial

There are 1.7 billion cases of childhood diarrhea infections reported annually in the world, causing death in 525,000 children under the age of five. Similarly, lower respiratory tract infections (LRTIs) contribute to morbidity and mortality, leading to 625,000 deaths and over 5 million hospital admissions in children under the age of five annually. As such, breastfeeding is recommended until six months of age due to the protective effect of human milk and its contribution to gut microbiota development in early life. The development of the gut microbiome in early life is influenced by nutrition intake in infancy, which is essential for immune system maturation and infection prevention. This randomized, double-blind, placebo-controlled study investigated the effect of synbiotic feeding during the first year of life on the incidence rate (IR) of infectious diarrhea. The secondary endpoints included the IR of other diseases and fecal milieu parameters. Four hundred and sixty healthy, 1-month-old infants randomly received either the synbiotic (galactooligosaccharides (GOS) and Limosilactobacillus fermentum CECT 5716; n=230) or control formula (n=230) until 12 months of age. Breastfed infants (reference group, n=80) were also included in the analysis. Stool samples were collected at 4 and 12 months of age and infection data were recorded. No significant difference was reported for the IR of infectious diarrhea during the first year of life between the groups. For secondary endpoints, the synbiotic group reported lower respiratory tract infections, significantly lower fecal pH at four months, and significantly higher secretory IgA at 12 months compared to control. As such, the IR of LRTIs may be reduced with synbiotic formula consumption in infancy. Additional research is warranted to investigate the mechanisms of gut-lung axis interactions.

Key takeaways:

  • Early life nutrition, including breastfeeding, contributes to robust gut microbiota development, which is involved in immune system maturation and infection prevention.
  • Synbiotic inclusion in infant formula may provide necessary nutrition in the absence of breastfeeding.
  • This study showed that synbiotic (GOS with L. fermentum CECT 5716) addition to infant formula may reduce the incidence of LRTIs and affect the immune system and fecal milieu.
  • Further studies that explore the gut-lung axis interactions are recommended.

Access the study: https://pubmed.ncbi.nlm.nih.gov/38462218/

Reference: Piloquet, H., Vrignaud, B., Gillaizeau, F., Capronnier, O., Berding, K., Günther, J., Hecht, C., Regimbart, C., & GOLF III Study Group (2024). Efficacy and safety of a synbiotic infant formula for the prevention of respiratory and gastrointestinal infections: a randomized controlled trial. The American journal of clinical nutrition, 119(5), 1259–1269. https://doi.org/10.1016/j.ajcnut.2024.03.005

 

Gut microbiome and inflammation among athletes in wheelchair in a crossover randomized pilot trial of probiotic and prebiotic interventions

Athletes in wheelchairs usually have various underlying conditions such as spinal cord or brain injuries or degenerative diseases affecting the central nervous system (CNS), which contribute to the high morbidity among this demographic. Gut health-related diseases are another significant contributor, and recent studies have indicated differences in the microbiome composition of adults experiencing CNS injuries and those without. Lifestyle factors also contribute to microbiome imbalance by frequent antibiotic use, physical inactivity, and psychological stress. This randomized, single-blinded, cross-over, pilot feasibility trial investigated the effects of probiotics versus prebiotics on improving inflammatory status and gut microbiome composition in elite Swiss athletes in wheelchairs. Fourteen subjects randomly received a 3 g sachet of a commercially available, freeze-dried, multispecies-multistrain probiotic (containing Bifidobacterium lactis W51, Bifidobacterium lactis W52, Enterococcus faeciumW54, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Lactobacillus plantarum W21, Lactobacillus salivarius W24, Lactococcus lactisW19) or 5 g prebiotic (oat bran) daily for four weeks. Serum samples were used to assess inflammatory markers and stool to characterize the gut microbiome. At baseline, most athletes (10/14) exhibited low inflammation levels, correlating with higher gut microbiome alpha diversity. Probiotic use had a higher decrease in 25/30 inflammatory markers (83%) compared to prebiotic use, although the difference was not statistically significant. Gut microbiome alpha diversity significantly increased after probiotic use compared to prebiotics, with community composition remaining stable. The small amount of 5 g of oat bran used in this study may be why no significant physiological effect was detected in the gut as higher doses of 40 g or more are usually required for a detectable effect. Future trials should validate these findings using larger sample sizes, higher inflammation rate populations, longer intervention periods, and differential abundance analysis to detect gut microbiome changes.

Key takeaways:

  • Probiotics and prebiotics may play a role in relieving gut microbiome-related health problems in athletes in wheelchairs.
  • This randomized, single-blinded, cross-over study investigated the effects of oat bran prebiotic versus multispecies-multistrain probiotic for four weeks on inflammatory markers and gut microbiome diversity in elite athletes in wheelchairs.
  • Probiotic use led to greater decrease in inflammatory markers than prebiotic use, although the difference was not statistically significant.
  • Probiotic use led to a higher increase in gut microbiome alpha diversity than prebiotics with no statistically significant difference.
  • Future studies that use larger sample sizes and longer intervention duration are needed to validate these results.

Access the study: https://pubmed.ncbi.nlm.nih.gov/38834634/

Reference: Valido, E., Capossela, S., Glisic, M., Hertig-Godeschalk, A., Bertolo, A., Stucki, G., Flueck, J. L., & Stoyanov, J. (2024). Gut microbiome and inflammation among athletes in wheelchair in a crossover randomized pilot trial of probiotic and prebiotic interventions. Scientific reports, 14(1), 12838. https://doi.org/10.1038/s41598-024-63163-z

 

The effect of microbiome-modulating agents (MMAs) on type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials

Type 1 diabetes (T1D) is an autoimmune disease where the body’s immune system attacks its insulin-producing pancreatic β cells, leading to insulin deficiency and impaired glucose metabolism. Recent case-control studies have shown significantly lower microbiota diversity in T1D compared to healthy controls, including an imbalanced Bacteroidetes-to-Firmicutes ratio, which leads to altered intestinal mucosa and gut permeability. As such, T1D patients experience increased levels of proinflammatory cytokines and lipopolysaccharides (LPSs) in the bloodstream as they more readily cross the colonocytes. Furthermore, the inflammatory status leads to decreased fasting C-peptide (FCP) and elevated glycemic levels. Tackling microbial dysbiosis is suggested to be a novel strategy for treating T1D, especially with insulin therapy, which requires subcutaneous insulin injection several times per day, being the most common type of therapy currently used, despite its various challenges, including high expense, weight gain, risk of hypoglycemia, and low adherence. Gut microbiome-modulating agents (MMAs), including probiotics, prebiotics, synbiotics, and postbiotics, may be used to restore the gut microbiota. This systemic review and meta-analysis assessed the impact of MMAs on hemoglobin A1c (HbA1c), a biomarker for long-term glucose control, and other biomarkers associated with T1D, including FCP and daily insulin usage (DIU). Seven databases were searched, including PubMed, Web of Science, Embase, Cochrane Library, National Knowledge Infrastructure, WeiPu, and WanFang Data from inception to 30 November 2023. Ten randomized controlled trials, including one study using a prebiotic (inulin), two studying a postbiotic (sodium butyrate), one testing a single-strain probiotic (Lactobacillus rhamnosus GG), and six reporting on multistrain probiotic or synbiotic supplements and consisting of 630 T1D patients were included after study quality evaluation using the Cochrane risk-of-bias tool. MMA supplementation was associated with significant improvements in HbA1c (reported by ten studies), DIU (reported by three studies), and FCP (reported by five studies). Subgroup analysis of HbA1c indicated that long-term interventions (over three months) may exert a more substantial effect. Further large-scale clinical trials are needed to substantiate the findings of this study.

Key takeaways:

  • Dysbiosis is a characteristic of the gut microbiota in T1D patients.
  • MMAs such as probiotics, prebiotics, synbiotics, and postbiotics, may be possible adjuvant therapies for T1D treatment.
  • This systemic review and meta-analysis reported that MMA intervention significantly improves HbA1c, DIU, and FCP.

Access to the study: https://pubmed.ncbi.nlm.nih.gov/38892608/

Reference: Zhang, Y., Huang, A., Li, J., Munthali, W., Cao, S., Putri, U. M. P., & Yang, L. (2024). The Effect of Microbiome-Modulating Agents (MMAs) on Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients, 16(11), 1675. https://doi.org/10.3390/nu16111675