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Background Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. Methods We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 8 0/7 –10 6/7  weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 24 0/7 –35 6/7  weeks, prior PPROM before 36 0/7  weeks, or spontaneous pregnancy loss at 14 0/7 –23 6/7  weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. Discussion This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes. Trial registration ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024.

Background One way to improve both the ecological performance and functionality of probiotic bacteria is by combining them with a prebiotic in the form of a synbiotic. However, the degree to which such synbiotic formulations improve probiotic strain functionality in humans has not been tested systematically. Our goal was to use a randomized, double-blind, placebo-controlled, parallel-arm clinical trial in obese humans to compare the ecological and physiological impact of the prebiotic galactooligosaccharides (GOS) and the probiotic strains Bifidobacterium adolescentis IVS-1 (autochthonous and selected via in vivo selection) and Bifidobacterium lactis BB-12 (commercial probiotic allochthonous to the human gut) when used on their own or as synbiotic combinations. After 3 weeks of consumption, strain-specific quantitative real-time PCR and 16S rRNA gene sequencing were performed on fecal samples to assess changes in the microbiota. Intestinal permeability was determined by measuring sugar recovery in urine by GC after consumption of a sugar mixture. Serum-based endotoxin exposure was also assessed. Results IVS-1 reached significantly higher cell numbers in fecal samples than BB-12 ( P  < 0.01) and, remarkably, its administration induced an increase in total bifidobacteria that was comparable to that of GOS. Although GOS showed a clear bifidogenic effect on the resident gut microbiota, both probiotic strains showed only a non-significant trend of higher fecal cell numbers when administered with GOS. Post-aspirin sucralose:lactulose ratios were reduced in groups IVS-1 ( P  = 0.050), IVS-1 + GOS ( P  = 0.022), and GOS ( P  = 0.010), while sucralose excretion was reduced with BB-12 ( P  = 0.002) and GOS ( P  = 0.020), indicating improvements in colonic permeability but no synergistic effects. No changes in markers of endotoxemia were observed. Conclusion This study demonstrated that “autochthony” of the probiotic strain has a larger effect on ecological performance than the provision of a prebiotic substrate, likely due to competitive interactions with members of the resident microbiota. Although the synbiotic combinations tested in this study did not demonstrate functional synergism, our findings clearly showed that the pro- and prebiotic components by themselves improved markers of colonic permeability, providing a rational for their use in pathologies with an underlying leakiness of the gut.

Although non-alcoholic fatty liver disease (NAFLD) is the leading aetiology of liver disorders in the world, there is no proven treatment for NAFLD patients with normal or low BMI. The aim of this study was to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI. In this randomised, double-blind, placebo-controlled, clinical trial, fifty patients with NAFLD were assigned to take either a synbiotic supplement or a placebo capsule for 28 weeks. Both groups were advised to follow a healthy lifestyle. At the end of the study, hepatic steatosis and fibrosis reduced in both groups; however, the mean reduction was significantly greater in the synbiotic group rather than in the placebo group (P<0·001). Furthermore, serum levels of fasting blood sugar, TAG and most of the inflammatory mediators reduced in the synbiotic group significantly compared with the placebo group (P<0·05). Our results provide evidence that synbiotic supplementation improves the main features of NAFLD in patients with normal and low BMI, at least partially through reduction in inflammatory indices. Further studies are needed to address the exact mechanism of action of these effects.

The aim of this study was to investigate the effects of 24-week synbiotic supplementation on chronic inflammation and the gut microbiota in obese patients with type 2 diabetes. We randomized 88 obese patients with type 2 diabetes to one of two groups for 24 weeks: control or synbiotic (Lacticaseibacillus paracasei strain Shirota (previously Lactobacillus casei strain Shirota) and Bifidobacterium breve strain Yakult, and galactooligosaccharides). The primary endpoint was the change in interleukin-6 from baseline to 24 weeks. Secondary endpoints were evaluation of the gut microbiota in feces and blood, fecal organic acids, high-sensitivity C-reactive protein, lipopolysaccharide-binding protein, and glycemic control. Synbiotic administration for 24 weeks did not significantly affect changes in interleukin-6 from baseline to 24 weeks (0.35 ± 1.99 vs. −0.24 ± 1.75 pg/mL, respectively). Relative to baseline, however, at 24 weeks after synbiotic administration there were positive changes in the counts of Bifidobacterium and total lactobacilli, the relative abundances of Bifidobacterium species such as Bifidobacterium adolescentis and Bifidobacterium pseudocatenulatum, and the concentrations of acetic and butyric acids in feces. No significant changes in inflammatory markers were found in the synbiotic group compared to the control group. However, synbiotic administration at least partially improved the gut environment in obese patients with type 2 diabetes.

•Synbiotics given preoperatively reduced inflammation, antibiotic use, and length of stay in postoperative colorectal cancer patients. Objectives: Gastrointestinal microflora is involved in the development and regulation of the immune response. Non-pathogenic bacteria are important to prevent the development and subsequent invasion of enteropathogenic bacteria. Surgical trauma and intestinal preparation can disrupt the intestinal microbiota balance. Modulating the microbiota in the preoperative period in patients with colorectal cancer may have an effect on the occurrence of postoperative complications. The aim of this study was to assess the effect of preoperative synbiotic administration in patients with colorectal cancer subjected to colorectal resection. Methods: This was a prospective, randomized, double-blind, placebo-controlled study of 73 patients with colorectal cancer. Eight days before surgery, patients were randomized to receive either synbiotics (Simbioflora, Farmoquimica, São Paulo, Brazi) or placebo (maltodextrin). The envelopes were identical and labeled A or B. All patients underwent nutritional assessment and measurements of C-reactive protein (CRP), interleukin (IL)-6, serum albumin, and transferrin. Patients were given a diluted envelope in 100 mL of water twice daily for 7 d. The occurrence of infectious or non-infectious complications, time of antibiotic use, duration of hospitalization, and occurrence of deaths were recorded for 30 d postoperatively. Results: Mean age, demographic data, and tumor staging were similar between the groups at baseline. After 7 d of synbiotic intake, there were significant reductions in IL-6 levels (163.2 ± 19.5 versus 138.8 ± 12.5, P < 0.001) and CRP (10 ± 5.2 versus 7.17 ± 3.2, P < 0.001), whereas the control group did not present significant changes I IL-6 levels (154.2 ± 18.3 versus 160.9 ± 18.6, NS) or CRP (10.6 ± 6.18 versus 10.4 ± 6.1, NS). Serum albumin and transferrin did not show significant changes. Postoperative infectious complications occurred in 2.8% of patients in the synbiotic group and in 18.9% of the control group (P = 0.02). The mean antibiotic usage time was 1.42 ± 0.5 d in the synbiotic group and 3.74 ± 4.3 d in the control group (P < 0.001). The mean hospital length of stay was 3 ± 1 d in the synbiotic group and 4 ± 18 in the control group (P < 0.001). Three deaths were reported in the control group and none in the synbiotic group (P = 0.115). Conclusions: The use of synbiotics for 7 d preoperatively in patients with colorectal cancer attenuates the inflammatory state and is associated with reductions in morbidity, hospital length of stay, and use of antibiotics.

Background: In healthy adults, probiotic supplementation alone does not increase Urolithin A (UroA) and rarely increases butyrate, both microbiome-derived metabolites that influence key biological functions involved in regulating gastrointestinal symptoms. Accordingly, this clinical trial evaluated key biological functions of a multi-species synbiotic with 24 probiotic strains and a polyphenol-based prebiotic using capsule-in-capsule delivery technology. Methods: We conducted a randomized, placebo-controlled trial among healthy participants (n = 32). Participants were administered a daily synbiotic (53.6 billion AFU multi-species probiotic and 400 mg Indian pomegranate extract; DS-01) or matching placebo for 91 days. Samples were obtained at baseline Day 0, and Days 7, 14, 49, and 91. Endpoints included changes in fecal microbiome composition, urinary UroA, fecal butyrate, serum CRP, and safety. Results: The synbiotic significantly increased alpha-diversity of Bifidobacterium and Lactobacillus spp. at all timepoints, including at end-of-study (Day 91, p < 0.0001) and increased native beneficial microbes. UroA production was significantly increased in the synbiotic arm at short-term (Day 7, 12-fold, p < 0.02) and long-term (Day 91, 49-fold, p < 0.001) timepoints. A higher proportion of synbiotic participants were capable of converting polyphenols into UroA (Day 91, 100% vs. 44.4%; p < 0.01). Mechanistically, synbiotic participants showed an increased abundance of Lactobacillus species involved in UroA precursor metabolism and UroA-producing Gordonibacter species. The synbiotic also significantly increased fecal butyrate levels (p < 0.03), and butyrate-producing species, in low-baseline butyrate producers, through Day 91, and was associated with reduced systemic inflammation. Conclusions: This multi-species synbiotic significantly increases diversity and abundance of key beneficial bacteria, enhances UroA production and butyrate levels, and is associated with lowered systemic inflammation. This is the first synbiotic to increase both UroA and butyrate.

Background Birth by cesarean section (C-section) is associated with a delayed colonization of bifidobacteria and Bacteroidota species with potential negative health consequences. Previously, an infant formula with a synbiotic mixture of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS [9:1]) and Bifidobacterium breve M-16V was found to restore the timely colonization of bifidobacteria in C-section born infants. In this study, we investigated the effect of this synbiotic mixture on gut microbiota development in C-section and vaginally–born infants participating in a growth equivalence trial (NCT03520764). Methods Healthy, fully formula-fed Chinese infants were randomized to receive a partially hydrolyzed whey-based protein formula with the synbiotic mixture ( n  = 112), or an intact protein formula with scGOS/lcFOS (prebiotic, n  = 112). Breastfed infants served as reference group ( n  = 60). Gut microbiota profiling by 16S rRNA gene sequencing of stools collected at baseline, 17 weeks (end of intervention) and 12 months of age was complemented with analysis of stool pH, short-chain fatty acids, lactic acids, and secretory IgA concentrations. Results Both the prebiotic and the synbiotic formula supported a dominant and diverse infant-type bifidobacterial community, but with increased abundance of Bifidobacterium breve in the synbiotic group. In C-section born infants (54.8% of randomized) the synbiotic but not the prebiotic, enhanced the bifidobacterial species diversity and showed restoration of Parabacteroides at 17 weeks, and Bacteroides spp. at 12 months closer to that of the vaginally–born infants. Conclusion The synbiotic was confirmed to support the restoration of important gut colonizers in infants born by C-section with effects observed even beyond the intervention period.

The purpose of the randomized double-blind placebo-controlled trial was to assess the effectiveness of synbiotic preparation containing probiotic Lactobacillus rhamnosus FloraActive™ 19070-2, Lactobacillus acidophilus DSMZ 32418, Bifidobacterium lactis DSMZ 32269, Bifidobacterium longum DSMZ 32946, Bifidobacterium bifidum DSMZ 32403 and fructooligosaccharides in adult patients with diarrhea-dominant IBS (IBS-D). The study included eighty patients with moderate and severe IBS-D who were randomized to receive synbiotics or placebo for eight weeks. Finally, a total of sixty-eight patients finished the study. The primary endpoints included the assessment of the symptoms’ severity with IBS symptom severity scale (IBS-SSS), an improvement of IBS global symptoms with Global Improvement Scale (IBS-GIS) and adequate relief of symptoms after four and eight weeks of therapy. Secondary endpoints, which were collected by telephone interviewers three times a week included the assessment of individual IBS symptoms and adverse events. Synbiotic treatment in comparison to placebo significantly improved IBS-GIS (p = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS (p = 0.042) and in domain-specific scores related to flatulence (p = 0.028) and bowel habit (p = 0.028) after four and eight weeks. Patients treated with synbiotics reported in weekly observations a significant amelioration in a feeling of incomplete bowel movements, flatulence, pain, stool pressure and diarrheal stools compared to those receiving placebo. There were no differences in adverse events between both groups. Concluding, the multi-strain synbiotic preparation was associated with a significant improvement in symptoms in IBS-D patients and was well-tolerated. These results suggest that the use of synbiotics offers a benefit for IBS-D patients. [Clinicaltrials.gov NCT04206410 registered 20 December 2019].

Infant colic is defined as a recurrent and prolonged period of fussing, crying and/or irritability that cannot be prevented or resolved by caregivers. The aim of this study is to evaluate the efficacy of a synbiotic (Bactecal D Liquid) in infants consulting a primary health care professional for inconsolable crying. A randomized trial was conducted in 68 infants diagnosed by the consulted primary health care professional as “probably suffering from infant colic”. Patients were randomized into two groups and given the synbiotic once (group 1) or twice (group 2) a day for 28 days. Quality of life (QoL) of the caregivers, evaluated with a Likert scale, was the primary outcome. Secondary outcomes included the total number of crying episodes, total crying time, gassiness and “balling of the fists”. The median (Q1;Q3) QoL scores were significantly ( p  < 0.001) higher on day 28 than at baseline: 6 (5;7) vs 2 (1;3). At baseline, there was no significant difference ( p  = 0.527) in QoL between both groups. The improvement in QoL was already significant after one week of intervention for both groups. The median number of crying episodes, overall crying time, gassiness and “balling of fists” were significantly lower on day 28 compared to baseline ( p  < 0.001). Conclusion : The synbiotic tested was shown to be efficacious in the management of infant colic. A significant improvement was observed after 7 days of intervention, which is much earlier than the expected decrease related to the natural evolution of infant colic. What is Known: • Some probiotic strains are reported to be effective in the management of infants presenting with colic, if breastfed. What is New: • The synbiotic studied improved quality of life of caregivers of infants presenting infant colic. • Two doses of the synbiotic were not more effective than one dose. • The improved occurred within one week. • The improvement was independent of feeding (breastfeeding, formula feeding or mixed feeding).

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with a highly immunosuppressive microenvironment. This single-blind, randomized study aimed to evaluate the synergistic immunomodulatory effects of synbiotics (probiotics and inulin prebiotics), as well as their impact on postoperative complications and outcomes, compared to the use of probiotics alone. Ninety patients diagnosed with PDAC were enrolled and randomly assigned into three groups: the placebo group, the probiotics group (receiving a mixture of ten strains of Lactobacillus, Bifidobacterium, and Streptococcus bacteria at a dose of 25 billion CFUs), and the synbiotics group (the same probiotics along with inulin prebiotics). The interventions were administered for 14 days before the surgery and continued for one month postoperatively. Tumor tissue infiltration of CD8 + T cells and the expression of IFN γ were assessed by immunohistochemistry (IHC). Inflammatory cytokines concentrations, including Il 1 B, IL 6, and IL 10, were evaluated as well by ELISA at various time points pre- and postoperative. Furthermore, patients were followed up after the surgery to assess postoperative short-term outcomes. Our results showed a significant elevation of CD8 + T cell proportion and IFN γ expression in the synbiotics group compared to the probiotics group (p = 0.049, p = 0.013, respectively). Inflammatory cytokines showed a significant gradual decrease in the synbiotics group compared to placebo and probiotics-treated groups (p = 0.000 for both). Administration of synbiotics and probiotics significantly decreased the rate of postoperative complications including anastomotic leakage, diarrhea, and abdominal distension (p = 0.032, p = 0.044, p = 0.042, respectively), with a remarkable reduction in bacteremia in the synbiotics group. These results revealed that this synbiotics formulation potentially enhances the immune response and reduces complications associated with surgery.Clinical trial identification: NCT06199752 (27-12-2023)