Bio-Kult

A. Approved and Widely Accepted Uses

• Restoration and Maintenance of Intestinal Microbiota
• For gut dysbiosis caused by antibiotics, infections, or dietary changes.
• Prevention and treatment of antibiotic-associated diarrhea (AAD).
• Supportive therapy in infectious diarrhea, travelers' diarrhea, and acute gastroenteritis.
• Functional Gastrointestinal Disorders
• Adjunct in managing irritable bowel syndrome (IBS), especially IBS-D.
• Support in functional constipation and bloating.
• Inflammatory and Immune Conditions
• Adjunct in inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease.
• May reduce recurrence and extend remission in IBD patients.
• Immunological Support
• Modulates immune response in allergy, eczema, and atopic dermatitis.
• Supports immune function in the elderly and immunocompromised patients (with caution).

B. Clinically Accepted Off-label Uses

• Adjunct in Helicobacter pylori eradication protocols.
• Prevention of necrotizing enterocolitis (NEC) in preterm neonates (strain-specific).
• Supportive therapy in metabolic disorders and gut-brain axis dysfunction (e.g., anxiety, depression).

Route: Oral (capsules, tablets, powder sachets)

Adults:

• General GI support or antibiotic use:
  1 capsule or sachet daily containing 10–50 billion CFU, taken with or just before meals.
• Acute diarrhea or IBS flare-up:
  1 capsule or sachet twice daily (as per strain potency).
• During antibiotic treatment:
  Begin within 12–24 hours of starting antibiotics; continue for at least 7–14 days after antibiotic course.

Pediatrics:

• Children >1 year:
  ½ to 1 sachet daily or age-specific chewables containing 1–10 billion CFU.
• Infants <1 year:
  Pediatric formulations only; dose as directed by physician.

Elderly:

• Same as adult dosing. Can be especially beneficial for immune modulation and microbiome restoration.

Special Populations:

• Renal/Hepatic Impairment:
  No dose adjustment required.
• Immunocompromised individuals:
  Use cautiously; initiate under physician supervision.

This 14-strain probiotic formulation contains a diverse spectrum of Lactobacillus, Bifidobacterium, Streptococcus thermophilus, and other beneficial bacterial species. These probiotics competitively inhibit pathogenic microbes, enhance mucosal barrier integrity, produce short-chain fatty acids (SCFAs), and regulate local immune responses in the gut-associated lymphoid tissue (GALT). Additionally, they modulate cytokine production, reduce intestinal inflammation, and help restore microbial diversity, thereby improving gut health, digestion, and systemic immune function.

• Absorption:
  Probiotics are not systemically absorbed. They exert local effects in the intestinal lumen and mucosa.
• Onset of Action:
  Generally within 1–3 days; full effects may take 1–2 weeks depending on strain and condition treated.
• Distribution:
  Colonize various segments of the gastrointestinal tract (transient or semi-permanent colonization).
• Metabolism:
  Not metabolized systemically. Participate in local fermentation and short-chain fatty acid production.
• Excretion:
  Elimination occurs via feces. Colonization may persist for several days post-treatment.

• Pregnancy:
  Considered safe during pregnancy when used at recommended doses. No evidence of teratogenicity from probiotic strains in use.
• Lactation:
  Safe during breastfeeding. Probiotics may benefit both maternal and neonatal microbiota development.
• Caution:
  Pregnant and lactating women with compromised immunity should consult a healthcare provider before use.

• Primary Class: Nutraceutical / Probiotic
• Subclasses:
• Multistrain probiotic supplement
• Live microbial dietary agent

• Known hypersensitivity to any ingredient or strain in the formulation
• Patients with central venous catheters (risk of bacteremia)
• Severe immunosuppression (e.g., post-transplant, chemotherapy)
• Acute pancreatitis (use with caution; evidence is evolving)

• Immunocompromised patients:
  Rare risk of probiotic-induced sepsis or fungemia; monitor closely.
• Critically ill or hospitalized patients:
  Use only under clinical supervision.
• Pediatric/neonatal use:
  Strain-specific products should be used with verified safety in infants.
• Product quality assurance:
  Use only well-researched, properly manufactured products with verified CFU counts and stability.

Common:

• Bloating
• Flatulence
• Mild abdominal discomfort
• Transient changes in stool consistency

Rare/Serious:

• Systemic infections (bacteremia/fungemia):
  Extremely rare, primarily in immunocompromised or hospitalized patients
• Hypersensitivity reactions:
  Rash, urticaria (rare)
• Fever or malaise:
  Very rare; typically in those with underlying chronic disease or immune suppression

• Antibiotics:
  May reduce efficacy of live probiotics; separate doses by 2–3 hours
• Immunosuppressants (e.g., corticosteroids, biologics):
  Increased risk of systemic infection—use with caution
• Antifungals (for yeast-based probiotics):
  May inactivate certain probiotic yeast strains like Saccharomyces boulardii
• Alcohol:
  Chronic use may impair gut microbiota restoration and reduce probiotic effectiveness

• 2024 WHO/FAO Recommendations:
  Emphasize strain specificity and CFU count validation in multi-strain probiotic formulations.
• 2023 AGA Guidelines (American Gastroenterological Association):
  Recommend probiotics selectively for IBS, pouchitis, and AAD; routine use not advised for healthy individuals without GI symptoms.
• Ongoing Research (2025):
  Evaluation of gut-brain axis modulation and mental health improvement with multispecies probiotics in anxiety and depression.

• Temperature:
  Store below 25°C. Some formulations may require refrigeration at 2°C to 8°C.
• Humidity & Light Protection:
  Keep away from moisture and direct sunlight.
• Packaging:
  Maintain in original container with desiccant. Avoid exposure to air.
• Handling:
  Do not freeze. Follow expiry dates for guaranteed CFU viability.
• Sachets:
  Use immediately after opening.