Proteria KIDS

A. Approved and Common Clinical Uses

• Gastrointestinal Microbiota Restoration:
• Prevents and treats antibiotic-associated diarrhea (AAD)
• Supports recovery from infectious diarrhea, gastroenteritis, and travelers’ diarrhea
• Used post-antibiotic therapy to restore healthy intestinal flora
• Functional Gastrointestinal Disorders:
• Adjunct therapy in irritable bowel syndrome (IBS) (especially IBS-D)
• Helps manage bloating, flatulence, mild constipation, and indigestion
• Immune System Modulation:
• Reduces frequency and severity of upper respiratory tract infections
• Modulates immune response in allergic rhinitis and eczema

B. Off-label and Emerging Uses

• Adjunct in Helicobacter pylori treatment regimens to reduce GI side effects
• Support in inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease (strain-dependent)
• Prevention of diarrhea in infants and children, especially in daycare settings
• Gut-brain axis regulation in mild anxiety or depression (under investigation)

Route of Administration: Oral (capsules, tablets, or sachets)

Adults:

• General health/GI support:
  1 capsule or sachet daily containing 4 billion CFU, preferably before meals
• During antibiotic therapy:
  1 capsule twice daily, continued for 7–14 days post-antibiotics

Pediatrics:

• Children aged 1–12 years:
  ½ to 1 sachet per day (powder mixed in milk, water, or food)
• Infants (<1 year):
  Pediatric-specific formulations only; consult a physician

Elderly:

• Same as adult dosing; beneficial for immunity and microbiota balance

Renal or Hepatic Impairment:

• No dose adjustment required

This 4 Billion CFU probiotic combination typically includes select strains of Lactobacillus, Bifidobacterium, and/or Streptococcus thermophilus. These live microorganisms colonize the gastrointestinal tract, inhibit growth of pathogenic bacteria, and restore healthy gut flora. They produce short-chain fatty acids (SCFAs) like acetate and butyrate, enhance mucosal barrier function, regulate local cytokine production, and stimulate the gut-associated lymphoid tissue (GALT), resulting in improved digestion, immune modulation, and reduced inflammation.

• Absorption: Not systemically absorbed; acts locally in the GI tract
• Onset of Action: Begins within 1–3 days of initiation
• Distribution: Colonizes small and large intestine temporarily or semi-permanently
• Metabolism: Participates in gut fermentation and SCFA production
• Elimination: Excreted through feces; transient colonization usually lasts for days after discontinuation

• Pregnancy:
  Not formally assigned a pregnancy category by the FDA. However, considered safe in pregnancy when used as a dietary supplement at standard doses.
• Lactation:
  Generally regarded as safe during breastfeeding. Some strains may improve maternal and infant GI health.
• Caution:
  Use only under medical supervision in immunocompromised pregnant or lactating individuals.

• Primary Class: Nutraceutical
• Subclass: Probiotic supplement (live microbial dietary agent)

• Known hypersensitivity to any of the product’s components
• Critically immunocompromised states (e.g., post-transplant, chemotherapy)
• Presence of central venous catheters (risk of bloodstream infections)
• Severe acute pancreatitis (caution advised)

• Immunocompromised patients:
  Rare risk of probiotic bacteremia/fungemia; use with caution
• Hospitalized or critically ill patients:
  Use under close medical supervision only
• Allergic reaction risk:
  May occur with components like dairy-derived cultures or capsule excipients
• Strain-specific benefits:
  Efficacy and safety depend on strain quality and viability; choose products with documented strain-specific clinical data

Common:

• Gastrointestinal:
• Mild bloating
• Flatulence
• Soft stools or minor GI discomfort (self-limiting)

Uncommon/Rare:

• Infections:
• Bacteremia or fungemia in severely immunocompromised patients (very rare)
• Allergic reactions:
• Urticaria, itching, rash
• Others:
• Headache, fatigue (rare and usually self-resolving)

• Antibiotics:
  May reduce probiotic viability—administer probiotics at least 2–3 hours apart
• Immunosuppressive agents (e.g., corticosteroids, cyclosporine):
  Increased risk of opportunistic infections—use with clinical oversight
• Antifungal agents:
  May antagonize certain probiotic yeast strains (if included)
• Alcohol:
  Excessive consumption may impair probiotic efficacy

• WHO/FAO 2023 Position:
  Reaffirmed safety of probiotic combinations in diarrhea prevention and recovery
• AGA 2024 Recommendation:
  Probiotics supported for AAD, IBS, and pouchitis; other uses to be considered strain-specific
• Ongoing Research (2025):
  Trials are exploring gut-brain axis effects, including in mild anxiety and depression; multi-strain lower-dose probiotics like 4 billion CFU are under evaluation for general wellness in healthy adults

• Temperature:
  Store below 25°C unless otherwise specified; refrigeration (2°C to 8°C) improves stability for some products
• Humidity:
  Store in a dry place with low humidity
• Light Protection:
  Keep away from direct sunlight
• Handling:
• Do not freeze
• Use sachets immediately after opening
• Keep the product tightly sealed in original packaging with desiccants