Product Name: XCELSIO wsp

Type: Water Soluble Powder - Bacteriophage Preparation for Drinking Water Administration

COMPOSITION

Contains a carefully selected cocktail of strictly virulent bacteriophages specifically targeting:

• Salmonella spp.
• Escherichia coli (including avian pathogenic E. coli, APEC)
• Staphylococcus aureus
• Clostridium perfringens
• Bacillus subtilis

Note: Quantitative concentration (PFU/g) available upon request; contact manufacturer for specific certificate of analysis.

DESCRIPTION

Bacteriophage

XCELSIO wsp (Water Soluble Powder) is an innovative, broad-spectrum bacteriophage-based feed additive specifically formulated for administration via drinking water. Bacteriophages are naturally occurring viruses that specifically infect and kill bacteria, offering a precise and effective alternative to conventional antimicrobials without disrupting beneficial gut microbiota .

The water-soluble format provides exceptional flexibility for livestock and poultry producers, enabling rapid response to disease challenges, targeted treatment of specific flocks or pens, and convenient application during critical production phases such as post-weaning, transport, or vaccination stress . This formulation dissolves readily in water, ensuring uniform distribution and consistent dosing across all animals in the production unit .

The product contains a cocktail of strictly virulent (lytic) bacteriophages, meaning they actively kill their target bacteria through a natural life cycle that results in bacterial cell lysis (destruction). This multi-phage cocktail approach ensures broad coverage against different strains of the target pathogens and helps prevent the development of phage-resistant bacteria .

MECHANISM OF ACTION

XCELSIO wsp works through the natural lytic cycle of bacteriophages:

1. Recognition and Attachment:

• Bacteriophages recognize and bind to specific receptors on the surface of their target bacteria
• This specificity ensures that only pathogenic bacteria are targeted, leaving beneficial microbes untouched

2. Infection and Replication:

• The phage injects its genetic material into the bacterial cell
• The phage hijacks the bacterium's cellular machinery to produce multiple copies of new phages

3. Bacterial Lysis:

• Newly assembled phages produce enzymes (lysins) that break down the bacterial cell wall
• The bacterial cell bursts (lyses), releasing the new phages to seek out and infect remaining target bacteria
• This self-amplifying characteristic means that phages continue to multiply as long as target bacteria are present

4. Biofilm Disruption:

• Bacteriophages can penetrate and disrupt bacterial biofilms, which are protective matrices that make bacteria more resistant to conventional disinfectants and antibiotics
• Research demonstrates that phages can reduce biofilm formation by over 90% and effectively remove existing mature biofilms

TARGET PATHOGENS AND INDICATIONS

XCELSIO wsp is specifically formulated to target five major pathogenic bacteria affecting livestock and poultry production:

1. Salmonella spp.:

• Causes salmonellosis, a major foodborne disease affecting both animals and humans
• In poultry, Salmonella infections lead to reduced performance, mortality, and food safety concerns
• In cattle, Salmonella Dublin causes severe illness and persistent herd infections
• Bacteriophage treatment significantly reduces Salmonella colonization in the cecum and spleen
• When administered in drinking water, phages can reduce Salmonella contamination in poultry carcasses and environmental load
• Studies demonstrate that bacteriophage products can decrease counts of Salmonella Enteritidis in caecal digesta and boot swabs of chickens for fattening
• Phages can reduce Salmonella on chicken meat by more than 92% (1.15 log10 CFU/mL reduction)

2. Escherichia coli (including APEC):

• Avian pathogenic E. coli (APEC) causes colibacillosis, a leading cause of mortality and morbidity in poultry worldwide
• In livestock, E. coli infections can cause diarrhea, septicemia, and reduced performance
• Bacteriophages effectively target E. coli without affecting beneficial gut flora
• Easy application via drinking water allows for rapid response to E. coli outbreaks

3. Staphylococcus aureus:

• Causes mastitis in dairy cattle, skin infections, and systemic disease
• In poultry, can cause arthritis, bumblefoot, and septicemia
• Important zoonotic pathogen with public health implications

4. Clostridium perfringens:

• Causes necrotic enteritis in poultry, a significant disease costing the industry over $6 billion annually
• In livestock, causes enterotoxemia, gas gangrene, and sudden death
• Bacteriophage supplementation significantly improves feed intake, body weight gain, and feed conversion ratio in birds challenged with C. perfringens
• Phage treatment reduces intestinal lesion scores and mortality in necrotic enteritis models

5. Bacillus subtilis:

• While often used as a probiotic, certain strains can cause opportunistic infections in immunocompromised animals
• The inclusion of B. subtilis-targeting phages allows for population management when needed
• Combined B. subtilis and bacteriophage supplementation in geese significantly enhanced body weight and feed efficiency

XCELSIO wsp is indicated for:

• Prevention and control of bacterial infections in poultry (broilers, layers, breeders, turkeys, ducks, geese) and livestock (cattle, swine, sheep, goats)
• Reduction of foodborne pathogens to improve food safety and reduce carcass contamination at processing
• Support for antibiotic-free production systems as a natural alternative to antimicrobial growth promoters
• Rapid response to disease outbreaks via drinking water administration
• Management of necrotic enteritis in poultry, reducing mortality and improving performance
• Reduction of Salmonella and E. coli shedding to improve flock health and reduce environmental contamination
• Biofilm control in the gastrointestinal tract and production environment

KEY ADVANTAGES OF WATER-SOLUBLE BACTERIOPHAGE TECHNOLOGY

• Rapid response capability: Water administration allows for immediate treatment of affected flocks or pens without feed changes
• Easy application: Simple addition to drinking water, suitable for all ages from day 1 onwards
• Uniform dosing: Ensures consistent intake across all animals, including sick or stressed individuals with reduced feed intake
• Targeted specificity: Kills only pathogenic bacteria without disrupting beneficial gut microbiota
• No antibiotic resistance: Different mechanism of action means no cross-resistance with antibiotics; phages can kill multidrug-resistant bacteria
• Self-amplifying: Phages multiply at the site of infection as long as target bacteria are present, providing sustained activity
• Biofilm penetration: Effectively penetrates and disrupts bacterial biofilms that protect pathogens from conventional treatments
• No withdrawal period: Safe for animals, humans, and the environment; leaves no residues in meat, milk, or eggs
• Flexible use: Can be used continuously for prevention or in short pulses for metaphylaxis and treatment
• Improves gut health and well-being: Reduces pathogen load while supporting overall digestive function
• Environmentally sustainable: Reduces environmental contamination with antibiotics and resistant bacteria

DOSAGE & ADMINISTRATION

XCELSIO wsp is administered via drinking water. For optimal results, fresh medicated water should be prepared daily.

Recommended Dosage:

• Poultry (Broilers, Layers, Breeders, Turkeys, Ducks, Geese): 100 - 500 g per 1000 liters of drinking water, administered daily
• Swine (Piglets, Growers, Sows): 50 - 250 g per 1000 liters of drinking water, administered daily
• Calves: 5 - 10 g per animal per day in milk replacer or drinking water
• Target daily dose: For Salmonella control, research indicates effective doses of 2 × 10⁶ PFU per bird when administered via drinking water

Dosing Based on Challenge Level:

• Preventive (low challenge): Lower end of dosage range, continuous use or 2-3 days per week
• Meta-phylactic (moderate challenge): Mid-range dosage, continuous use during risk periods
• Therapeutic (high challenge/outbreak): Upper end of dosage range, administer for 3-5 consecutive days or until clinical signs resolve

Administration Guidelines:

• Preparation: Dissolve the required amount of XCELSIO wsp in a small volume of clean water, then add to the main drinking water tank or proportioner system
• Water quality: Use clean, non-chlorinated water. If chlorinated water is unavoidable, dechlorinate using approved methods or increase dosage to compensate for chlorine degradation
• Medication time: Administer over 4-8 hours to ensure all animals consume an adequate dose. Ensure sufficient drinker space to prevent competition
• Withholding water: Consider withholding water for 1-2 hours before treatment to encourage rapid consumption of medicated water
• Fresh preparation: Prepare fresh phage solution daily; discard any unused solution after 24 hours
• Compatibility: Compatible with most vitamins, electrolytes, and other water-soluble additives. Avoid simultaneous use with strong disinfectants or high levels of chlorine

EFFICACY DATA

Against Salmonella spp.:

• EFSA evaluations confirm that bacteriophage products administered in drinking water have the potential to decrease the counts of Salmonella Enteritidis strains in boot swabs and caecal digesta of chickens for fattening
• Bacteriophage treatment reduces the environmental load of Salmonella, contributing to improved flock health and food safety
• Low-dose phage treatment (10⁵ PFU/mL) reduces splenic Salmonella colonization in chickens and improves albumin-to-globulin ratios
• Phage treatment enriches beneficial taxa like Lactobacillus crispatus and Blautia coccoides while suppressing pathogens
• On chicken meat, phage treatment reduces Salmonella Enteritidis by 1.15 log10 CFU/mL (>92% reduction) after 12 hours at 4°C
• Phages inhibit more than 70-91% of Salmonella biofilm formation and remove up to 96% of mature biofilms

Against Clostridium perfringens (Necrotic Enteritis):

• Bacteriophage supplementation significantly improves feed intake, body weight gain, and feed conversion ratio in broilers challenged with C. perfringens (P < 0.05)
• Intestinal lesion scores and mortality are effectively reduced with phage treatment
• Jejunal histomorphology and hematological indices show notable restoration in phage-treated birds

Against E. coli:

• Bacteriophage products have demonstrated effectiveness in controlling colibacillosis in poultry, showing lower mortality rates compared to untreated groups

Combined with Bacillus subtilis:

• Combined supplementation of B. subtilis and bacteriophages in geese significantly enhances body weight and feed efficiency
• The combination treatment reduces serum and aquatic endotoxin levels while suppressing pathogenic bacteria (E. coli and Salmonella) in water systems
• Intestinal morphology improves with increased villus height and optimized villus-to-crypt ratios

SAFETY ASSESSMENT

Based on extensive safety evaluations of similar bacteriophage products:

• Target species safety: Bacteriophage additives are safe for all target species, including poultry and livestock
• Consumer safety: No safety concerns for consumers of animal products; bacteriophages are naturally occurring and leave no residues
• Environmental safety: Safe for the environment; bacteriophages are ubiquitous in nature and biodegradable
• User safety: Not a skin or eye irritant, but should be considered a potential respiratory sensitiser; appropriate dust masks should be worn during handling

CONTRAINDICATIONS & PRECAUTIONS

• No known contraindications when used as directed at recommended inclusion rates
• Water quality: Avoid high levels of chlorine in drinking water; dechlorinate if necessary
• Storage: Store in a cool, dry place away from direct sunlight and moisture
• Protect from temperatures exceeding 40°C (104°F) for extended periods
• Use within 24 months of manufacturing date when stored properly
• Keep out of reach of children
• Wear appropriate dust mask during handling to avoid inhalation of fine particles (potential respiratory sensitiser)
• Generally Recognized as Safe (GRAS) for use in animal feed; safe for animals, humans, and the environment

WITHDRAWAL PERIOD

• Zero days for meat, milk, and eggs
• Bacteriophages are naturally occurring and leave no residues in animal products

STORAGE

• Store in original unopened packaging in a cool, dry place
• Keep at temperature below 25°C (77°F) for optimal stability
• Protect from humidity, moisture, and direct sunlight
• Close tightly after each use to prevent moisture absorption
• Do not store near chemicals, pesticides, or fertilizers
• Avoid exposure to high temperatures or freeze-thaw cycles

Target Species: Poultry (broilers, layers, breeders, turkeys, ducks, geese), Swine (piglets, growers, sows), Cattle (dairy, beef, calves), Sheep, Goats

Pack Sizes: 1 Kg, 20 Kg

PRODUCT SUMMARY
XCELSIO wsp Water Soluble Powder Bacteriophage Bacteriophages targeting Salmonella spp., E. coli, Staphylococcus aureus, Clostridium perfringens, Bacillus subtilis Poultry 1 Kg,20Kg

FOR VETERINARY USE ONLY