Lactobacillus Rhamnosus GG

Approved and Clinically Accepted Uses:

• Acute Infectious Diarrhea (e.g., Rotavirus):
  Used as adjunct therapy to reduce the duration and severity of diarrhea in children and adults.
• Antibiotic-Associated Diarrhea (AAD):
  Prevents and treats diarrhea resulting from antibiotic use, especially in children, elderly, and hospitalized patients.
• Clostridioides difficile Infection (Adjunct):
  Used alongside standard treatment to reduce the risk of recurrence in patients treated for C. difficile colitis.
• Irritable Bowel Syndrome (IBS):
  Helps relieve symptoms such as abdominal pain, bloating, and altered bowel habits.
• Inflammatory Bowel Disease (IBD):
  Adjunctive use in ulcerative colitis and pouchitis to support mucosal health and maintain remission.
• Traveler’s Diarrhea:
  Used prophylactically to prevent travel-related diarrhea.
• Atopic Dermatitis (Eczema) in Infants:
  May reduce the incidence or severity of eczema in genetically predisposed infants.
• Vaginal Microbiota Support (Off-label):
  May help restore normal vaginal flora in conditions like bacterial vaginosis and candidiasis when used orally.
• General Probiotic Use:
  Maintains healthy gut flora and supports digestive and immune health.

Route: Oral
Frequency: Once or twice daily depending on condition
Duration: Varies by indication

Adults:

• General probiotic: 10⁹ to 10¹⁰ CFU daily
• IBS/IBD support: 10¹⁰ to 10¹¹ CFU/day
• Traveler’s diarrhea prevention: 10⁹ to 10¹⁰ CFU daily, starting 2–3 days before travel and continued throughout

Children (≥6 months):

• Acute diarrhea / AAD prevention: 10⁹ CFU/day in 1–2 divided doses for 5–7 days
• Eczema prevention (infants): 10⁹ CFU daily, possibly starting in the mother during late pregnancy

Elderly:

• Same as adult dosing; generally well tolerated

Special Populations:

• Renal/hepatic impairment: No dose adjustment required
• Immunocompromised: Use only under medical supervision

Administration Notes:

• Can be taken with or without food
• Capsules may be opened and mixed with cold or lukewarm liquids or soft foods
• Avoid mixing with hot fluids (>40°C), which may destroy live organisms

Route: Oral
Frequency: Once or twice daily depending on condition
Duration: Varies by indication

Adults:

• General probiotic: 10⁹ to 10¹⁰ CFU daily
• IBS/IBD support: 10¹⁰ to 10¹¹ CFU/day
• Traveler’s diarrhea prevention: 10⁹ to 10¹⁰ CFU daily, starting 2–3 days before travel and continued throughout

Children (≥6 months):

• Acute diarrhea / AAD prevention: 10⁹ CFU/day in 1–2 divided doses for 5–7 days
• Eczema prevention (infants): 10⁹ CFU daily, possibly starting in the mother during late pregnancy

Elderly:

• Same as adult dosing; generally well tolerated

Special Populations:

• Renal/hepatic impairment: No dose adjustment required
• Immunocompromised: Use only under medical supervision

Administration Notes:

• Can be taken with or without food
• Capsules may be opened and mixed with cold or lukewarm liquids or soft foods
• Avoid mixing with hot fluids (>40°C), which may destroy live organisms

• Absorption: Not absorbed systemically; acts locally in the gastrointestinal tract
• Distribution: Confined to the gut; no systemic distribution
• Metabolism: Not metabolized by human enzymes
• Excretion: Excreted in feces within 3–7 days after discontinuation
• Onset of Action: Clinical effects typically observed within 1–3 days
• Bioavailability: Not systemically bioavailable
• Half-life: Not applicable

• Pregnancy:
  – No FDA pregnancy category assigned
  – Generally considered safe during pregnancy when taken orally
  – No evidence of teratogenicity or harm to the fetus
• Lactation:
  – Safe to use during breastfeeding
  – No adverse effects expected in nursing infants
  – May positively influence infant gut microbiota
• Caution:
  – In immunocompromised mothers or infants, use only under physician guidance

• Primary Class: Probiotic
• Sub-Class: Lactic acid-producing, gram-positive, non-pathogenic bacteria

• Known hypersensitivity to Lactobacillus rhamnosus GG or formulation components
• Critically ill or immunocompromised patients (e.g., post-transplant, chemotherapy)
• Presence of central venous catheters (risk of sepsis)
• Severe gastrointestinal barrier compromise

• High-Risk Groups:
  – Immunocompromised individuals
  – Neonates or critically ill patients with central lines
  – Use only with physician supervision in these populations
• Serious Potential Risks:
  – Rare cases of bacteremia or sepsis reported in vulnerable patients
  – Risk of fungal or bacterial contamination in improperly stored products
• Monitoring:
  – Observe for signs of infection in at-risk patients
  – Choose high-quality, clinically tested formulations

Gastrointestinal (Common):

• Mild bloating
• Flatulence
• Abdominal discomfort
• Diarrhea (transient)

Hypersensitivity (Rare):

• Skin rash
• Pruritus
• Urticaria

Serious (Very Rare):

• Sepsis or bacteremia (mainly in immunocompromised or ICU patients)
• Endocarditis (extremely rare)

Timing:

• Side effects usually appear within the first few days of use
• Most are self-limiting and do not require discontinuation

• Antibiotics:
  – May reduce probiotic viability; administer at least 2 hours apart
• Immunosuppressive Agents:
  – Use with caution; risk of systemic infection
• CYP450 Enzymes:
  – Not metabolized via CYP450 pathways; no known CYP-related interactions
• Food & Alcohol:
  – No significant interactions; alcohol may disrupt gut flora

• ESPGHAN/ESPID Guidelines:
  – Recommend Lactobacillus rhamnosus GG for acute pediatric diarrhea and AAD prevention
• WHO Recommendations:
  – Recognized as a safe and effective adjunct in pediatric acute diarrhea management

Clinical Trends:
– Studied in COVID-19 and other emerging indications for immune and gut health support
– Expanding evidence base for eczema prevention and microbiome restoration

• Temperature:
  – Store at 2°C to 8°C (refrigerated) unless labeled shelf-stable
  – Some strains may be stable at room temperature (≤25°C) for short periods
• Humidity:
  – Store in a dry place; protect from moisture
• Light Protection:
  – Keep in original packaging; avoid exposure to sunlight
• Handling Instructions:
  – Do not freeze
  – Do not use past the expiry date
  – Avoid hot beverages or food (>40°C) when administering