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Enterotoxigenic Escherichia coli (ETEC) commonly cause diarrhea in children living in developing countries and in travelers to those regions. ETEC are characterized by colonization factors (CFs) that mediate intestinal adherence. We assessed if bovine colostral IgG (bIgG) antibodies against a CF, CS17, or antibodies against CsbD, the minor tip subunit of CS17, would protect subjects against diarrhea following challenge with a CS17-expressing ETEC strain. Adult subjects were randomized (1:1:1) to receive oral bIgG against CS17, CsbD, or placebo. Two days prior to challenge, subjects began dosing 3 times daily with the bIgG products (or placebo). On day 3, subjects ingested 5 × 109 cfu ETEC strain LSN03-016011/A in buffer. Subjects were assessed for diarrhea for 120 hours postchallenge. A total of 36 subjects began oral prophylaxis and 35 were challenged with ETEC. While 50.0% of the placebo recipients had watery diarrhea, none of the subjects receiving anti-CS17 had diarrhea (P = .01). In contrast, diarrhea rates between placebo and anti-CsbD recipients (41.7%) were comparable (P = 1.0). This is the first study to demonstrate anti-CS17 antibodies provide significant protection against ETEC expressing CS17. More research is needed to better understand why anti-CsbD was not comparably efficacious. Clinical Trials Registration. NCT00524004.

COVID-19 pandemic is currently relatively controlled, mainly due to effective vaccines. Preparedness for future outbreaks should include means for reducing transmission of SARS-CoV-2 and other coronaviruses like MERS-CoV. Approximately 72% of camels in Israel are seropositive for MERS-CoV and may exhibit cross-reactivity with serologically related SARS-CoV-2, suggesting therapeutic possibilities. Aims:To investigate the potential of camel-derived anti-MERS-CoV antibodies from camels colostrum for mucosal use in humans, as MERS-CoV prophylaxis and to control COVID-19 progression and infectivity. Methods:Using ELISA assay, we screened serum and colostrum of MERS-CoV seropositive camels for MERS-CoV antibody titers and neutralization potency and for cross-reactivity with SARS-CoV-2 spike. Next, we performed an open label placebo controlled randomized trial, comparing the effect of mucosal application of colostrum to placebo. Infectivity and viral load levels were evaluated daily up to 96 h. Results:Anti-MERS-CoV spike reactive antibodies with partial SARS-CoV-2 cross-reactivity were detected in 22 serum and 12 colostrum samples. While SARS-CoV-2 cross-neutralization was detected, its potency was significantly weaker than that of MERS-CoV. Neutralization of spike pseudotyped reporter viruses representing MERS-CoV reached ~ 1:500, while neutralization against SARS-CoV-2 wild type and variants was only at (NT50) ≤ 1:120. Forty-three COVID-19 patients were recruited to the randomized controlled trial. The primary endpoints did not differ between groups, with comparable decline in viral load ( p  = 0.311) and infectivity ( p  = 0.9641) after 24-h. Conclusions:In-vitro, camel colostrum-derived antibodies neutralize MERS-CoV, but a thin colostrum preparation did not reduce infectivity or viral load in SARS-CoV-2 infected individuals. The role of camel colostrum-derived antibody-concentrate and more viscous preparations merit further evaluation as potential prophylaxis and treatment against MERS-CoV.

Based on the immunological properties of maternal colostrum, this study aimed to determine the effect of oropharyngeal colostrum on preventing late-onset sepsis in preterm infants. This clinical trial was conducted from May 2023 to June 2024 at Rouhani Hospital with 70 premature infants. In the control group, no colostrum was administered, while the intervention group received 0.4 ml of colostrum every three hours for seven days, with extraoral massage for better absorption. The relative risk of late-onset sepsis was 55% lower in the intervention group (RR = 0.45, 95% CI: 0.17 to 1.16). Although the difference in sepsis incidence between the groups was not statistically significant (11, 32.4% vs. 5, 14.7% infants, P  = 0.086), it was clinically important. The age of achieving full enteral feeding was significantly lower in the intervention group (4.47 ± 2.33 vs. 3.24 ± 2.10 days, P  = 0.025), but no significant differences were found in the age of achieving independent oral feeding, weight gain at discharge, or length of hospitalization. This study suggests that oropharyngeal colostrum may help reduce the incidence of late-onset sepsis and decrease the time to achieve full enteral feeding in preterm infants. Trial registration : IRCT, IRCT20230312057698N1. Registered 29 March 2023 prospective, https://irct.behdasht.gov.ir/trial/69281 .

For very preterm infants, human milk is often fortified with formula products based on processed bovine milk. Intact bovine colostrum (BC), rich in anti-inflammatory milk factors, is considered an alternative. We investigated if BC affects anti-inflammatory/T 2 immunity and infection risk in very preterm infants. For a secondary analysis of a multicenter, randomized controlled trial (NCT03537365), very preterm infants (26-31 weeks gestation, 23% small for gestational age, SGA) were randomized to receive BC (ColoDan, Biofiber, Denmark, n = 113) or conventional fortifier (PreNAN, Nestlé, Switzerland, n = 116). Infection was defined as antibiotic treatment for five or more consecutive days and 29 cytokines/chemokines were measured in plasma before and after start of fortification. In general, infection risk after start of fortification was associated with low gestational age, SGA status and antibiotics use prior to fortification. Adjusted for confounders, infants fortified with BC showed more infection episodes (20 vs 12%, P < 0.05) and higher cumulative infection risk (hazard ratio, HR 1.9, P = 0.06), particularly for SGA infants (HR 3.6, P < 0.05). Additionally, BC-fortified infants had higher levels of T 2-related cytokines/chemokines (IL-10, MDC, MCP4) and reduced levels of cytokines related to T 1/T 17-responses (IL-15, IL-17, GM-CSF). The differences were most pronounced in SGA infants, displaying higher levels of T 2-related IL-4, IL-6, and IL-13, and lower interferon-γ and IL-1α levels in the BC group. Infants fortified with BC displayed a delayed shift from T 2- to T 1-biased systemic immunity, notably in SGA infants, possibly influenced by multiple confounding factors, alongside elevated antibiotic use, suggesting increased susceptibility to infection.

Background. Tip-localized adhesive proteins of bacterial fimbriae from diverse pathogens confer protection in animal models, but efficacy in humans has not been reported. Enterotoxigenic Escherichia coli (ETEC) commonly elaborate colonization factors comprising a minor tip adhesin and major stalk-forming subunit. We assessed the efficacy of antiadhesin bovine colostral IgG (bIgG) antibodies against ETEC challenge in volunteers. Methods. Adults were randomly assigned (1:1:1) to take oral hyperimmune bIgG raised against CFA/I minor pilin subunit (CfaE) tip adhesin or colonization factor I (CFA/I) fimbraie (positive control) or placebo. Two days before challenge, volunteers began a thrice-daily, 7-day course of investigational product administered in sodium bicarbonate 15 minutes after each meal. On day 3, subjects drank 1 × 109 colony-forming units of colonization factor I (CFA/I)-ETEC strain H10407 with buffer. The primary efficacy endpoint was diarrhea within 120 hours of challenge. Results. After enrollment and randomization, 31 volunteers received product, underwent ETEC challenge, and were included in the per protocol efficacy analysis. Nine of 11 placebos developed diarrhea, 7 experiencing moderate to severe disease. Protective efficacy of 63% (P = .03) and 88% (P = .002) was observed in the antiadhesin bIgG and positive control groups, respectively. Conclusions. Oral administration of anti-CFA/I minor pilin subunit (CfaE) antibodies conferred significant protection against ETEC, providing the first clinical evidence that fimbrial tip adhesins function as protective antigens.

Objective: Oral colostrum priming (OCP) after birth in preterm infants is associated with improved weight gain and modification of the oral immunomicrobial environment. We hypothesized that OCP would modify salivary immune peptides and the oral microbiota in preterm infants. Study design: We conducted a prospective, randomized clinical trial to determine the effects of OCP on salivary immune peptide representation in preterm infants (<32 weeks completed gestation at birth). Saliva samples were collected before and after OCP. Salivary immune peptide representation was determined via mass spectroscopy. Oral microbiota representation was determined via sequencing of the 16S rRNA gene. Results: Neonates who received OCP ( n =48) had a 16-day reduction in the median length of hospitalization as compared with infants who did not receive OCP ( n =51). No differences in salivary immune peptide sequence representation before OCP between groups were found. Longitudinal changes in peptides were detected (lysozyme C, immunoglobulin A, lactoferrin) but were limited to a single peptide difference (α-defensin 1) between primed and unprimed infants after OCP. We found no difference in microbial diversity between treatment groups at any time point, but diversity decreased significantly over time in both groups. OCP treatment marginally modified oral taxa with a decline in abundance of Streptococci in the OCP group at 30 days of life. Conclusions: OCP had neither an effect on the salivary peptides we examined nor on overall oral bacterial diversity and composition. Infants who received OCP had a reduced length of hospitalization and warrants further investigation.

IntroductionOropharyngeal colostrum administration (OCA) confers immunological benefits to very low birth weight infants (VLBWIs) through nutrient absorption via oropharyngeal lymphatic tissue, potentially reducing complication rates and improving clinical outcomes. Current evidence demonstrates significant variability in OCA protocols regarding the initiation timing, application frequency, treatment duration and dosage of this therapy across studies, and limited research exists on its impact on haematological indices in infants. Notably, the dose-dependent effects of OCA on both clinical outcomes and haematological immunological parameters in VLBWIs remain insufficiently investigated. We hypothesise that varying OCA doses will demonstrate differential impacts on clinical outcomes and systemic levels of key immunological markers in VLBWIs.Methods and analysisThis single-centre, three-arm, parallel-controlled randomised controlled trial will enrol 129 VLBWIs to evaluate the efficacy of OCA. Using a blinded design, both outcome assessors and data analysts will be masked to group allocation throughout the study. Participants will be randomly assigned in a 1:1:1 ratio into three groups: two receiving OCA (0.2 mL colostrum every 3 hours or 6 hours for 10 days) and a control group with standard care only. The primary endpoints of this trial are to compare the incidence of necrotising enterocolitis, bronchopulmonary dysplasia and retinopathy of prematurity across the three groups. Additionally, we will assess haematological and immunological indicators, including IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and serotype immunoglobulin A levels, to evaluate the potential effects of different OCA dosages on these parameters.Ethics and disseminationThis study protocol received full ethical approval (No. KLL-2023–505) from the ethics committee of the Affiliated Hospital of Zunyi Medical University on 5 September 2023, after a thorough review. The study findings will be disseminated through publication in peer-reviewed journals.Trial registration numberChiCTR2300077114. Registration on 31 October 2023.

(COL) is assumed to be one of the strongest natural immune stimulants. Regular ingestion of COL may contribute to improved immune response in athletes exposed to high training loads. Twenty-eight endurance-trained males aged 31.1 ± 10.2 years (body mass 81.9 ± 9.0 kg; height 1.82 ± 0.06 m) completed this randomized double-blind placebo(PLA)-controlled crossover study aimed at investigating the effect of 12-week COL supplementation (25g ·day ) on resting (REST), exercise-induced (POST-EX), and short-term post-exercise recovery (REC; 1 h after test exercise) changes in selected saliva and blood immunoglobulins (Ig), white blood cell (WBC) count and differential; as well as blood hematological, nutritional status and muscle damage indices. The protocol assumed 4 study visits - before/after supplementation with COL ( and ) and PLA ( and ). During testing sessions, incremental rowing test to exhaustion and swimming-specific performance test were introduced as exercise stimuli. At visit the secretory IgA (SIgA) concentration in saliva was significantly higher at POST-EX and REC compared to REST ( <0.05). COL supplementation had no effect on blood IgA, IgE, IgD, IgG, and IgM concentrations. Furthermore, after COL supplementation decrease of hematocrit at REC ( <0.05) was revealed. 12-week supplementation with 25 g ·day in endurance-trained male athletes resulted in a favorable increase in post-exercise concentration of salivary SIgA. COL seems to be a potential stimulator of local immune defense after exercise-induced homeostasis disturbances. Nevertheless, the lack of effect on blood markers indicates the need for further research in the area of mechanisms underlying the effect of the supposed COL immunological capacity.

Soluble CD14 (sCD14) is one of the immunomodulatory factors in breast milk (BM). Although it may be involved in the prevention of atopic symptoms and sensitization to both food and inhalant allergens, conflicting evidence exists concerning its protective effects. In this study, we investigated the relationship between sCD14 in colostrum and 1-month BM, and the development of atopic dermatitis (AD) and sensitization to food and aeroallergens at 9 months of age in infants who were exclusively or almost exclusively breastfed up to 4 months of age. BM samples were collected from lactating mothers who participated in a 2 × 2 factorial, randomized, nontreatment controlled trial study set in Tokyo, which looked at the efficacy of emollients and synbiotics in preventing AD and food allergy in children during the first year of life. A total of 258 colostrum samples and 269 1-month BM samples were analyzed. We found that one-month BM sCD14 levels in the AD group were significantly lower than in the non-AD group. Levels of sCD14 in 1-month BM were not related to allergen sensitization in the overall analysis, but egg white sensitization correlated inversely with 1-month BM sCD14 in infants without AD. The results suggest that sCD14 in BM may be involved in atopic manifestations in early infancy.

Background Extrauterine growth restriction (EUGR), prevalent and severe in very preterm infants (< 32 weeks’ gestation), means discharge growth values (weight, head circumference, or length) are ≤ 10th percentile on the Fenton 2013 chart. Many of these infants fast or have delayed oral feeding soon after birth. Oropharyngeal colostrum administration, using a syringe or sterile swab, is an alternative to early enteral colostrum feeding. As the effectiveness of oropharyngeal colostrum administration in reducing the incidence of EUGR in preterm infants remains unclear, a randomized trial design is crucial for addressing this question. This proposed study protocol investigates the impact of oropharyngeal colostrum administration on the time to regain birth weight and postnatal growth in very preterm infants, based on the interaction between early gut microbiota and the host. Methods We plan to perform this multicenter randomized controlled trial by recruiting 260 very preterm infants from September 2025 to August 2028. The study will be conducted at five neonatal intensive care units (NICUs) in Jiangsu Province, China. The study population will be randomly assigned to either the oropharyngeal colostrum administration group or the placebo (normal saline) group. The intervention will commence within 48–72 h of birth and and will be administered continuously for a duration of 5 days, with stool samples collected from the preterm infants before and after the intervention. The primary outcome measure is the incidence of EUGR at discharge, while the secondary outcome measures include differences in the time to regain birth weight and gut microbiota between groups. This study will use a multivariate logistic regression to evaluate the association between oropharyngeal colostrum administration and EUGR, multiple tests (T-test, Wilcoxon, repeated measures analysis of variance) for gut microbial diversity differences, and a generalized linear model for the association between the intervention and gut microbiota composition. Discussion This study aims to provide a scientific basis for the clinical application of oropharyngeal colostrum administration in preterm infants through rigorous clinical trials and intestinal flora analyses and to provide new insights into intervention strategies for EUGR in preterm infants. Trial registration ClinicalTrials.gov identifier: NCT07082881. Registered 16 July 2025.