Usage
This combination of probiotics is prescribed for various gastrointestinal disorders, including:
- Antibiotic-associated diarrhea
- Infectious diarrhea
- Gastroenteritis
- Inflammatory bowel disease (IBD)
- Constipation
- Clostridium difficile-associated diarrhea
- Helicobacter pylori infection (as an adjunct to eradication therapy)
- Traveler’s diarrhea
- Diarrhea in pregnant women
- Lactose intolerance
- Irritable Bowel Syndrome (IBS)
It is also sometimes used for allergic disorders, obesity, common cold, eczema, inflammatory arthritis, vaginal yeast infections, and urinary tract infections although robust evidence might be lacking for these conditions.
Pharmacological Classification: Probiotic
Mechanism of Action: This combination product works by restoring and maintaining the balance of gut flora. Each component contributes in specific ways:
- Bacillus mesentericus: Inhibits the growth of pathogenic bacteria and aids digestion.
- Clostridium butyricum: Produces butyric acid, a crucial nutrient for gut lining, promoting beneficial bacteria growth, and interferes with the growth of pathogens like C. difficile.
- Lactobacillus sporogenes: Improves gastrointestinal ecology by maintaining microflora balance and may incorporate cholesterol into the cell wall improving lipid levels.
- Saccharomyces boulardii: A non-pathogenic yeast that helps restore gut flora, particularly useful in antibiotic-associated diarrhea.
- Streptococcus faecalis: Helps clear diarrhea, stimulates the immune system, balances intestinal microflora, and may reduce lactose intolerance symptoms.
Alternate Names
Some alternate names and brand names for this combination include:
- Bio-Three
- Next Gut Capsule
- Bactolac
- Gutgermina
How It Works
Pharmacodynamics: The combined effect of these probiotics helps to restore a healthy gut microbiota, supporting normal digestive function and boosting local immunity. Butyric acid produced by C. butyricum is essential for the health of the intestinal epithelium.
Pharmacokinetics:
- Absorption: These probiotics are primarily active within the gastrointestinal tract and have minimal systemic absorption.
- Metabolism: The probiotics themselves are metabolized within the gut, with some strains producing beneficial byproducts like butyric acid and lactic acid.
- Elimination: Primarily eliminated through feces.
Mode of Action: Each strain works through different mechanisms, including competitive exclusion of pathogens, production of antimicrobial substances, and modulation of the immune system.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: While specific interactions are not fully elucidated, the probiotics may interact with gut receptors, impacting inflammatory pathways. Butyric acid produced can modulate gene expression affecting gut health.
Dosage
Standard Dosage
Children: Dosage for children should be determined by a healthcare professional, considering factors such as the child’s age, weight, and specific health condition.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Dosage modifications should be considered based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dosage adjustments may be necessary due to altered metabolism.
- Patients with Comorbid Conditions: Dosage adjustments may be needed depending on the specific comorbid condition.
Clinical Use Cases
Currently, specific dosage recommendations for clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations are not explicitly defined. Clinical experience and patient status should guide any dosage modifications in such scenarios.
Dosage Adjustments
Dosage modifications should be individualized and tailored to the patient’s specific circumstances. Factors to consider include renal or hepatic impairment, metabolic disorders, and other medications being taken.
Side Effects
Common Side Effects:
- Gas
- Bloating
- Abdominal discomfort
- Nausea
- Diarrhea
- Constipation
- Itching
- Hiccups
Rare but Serious Side Effects:
Serious side effects are rare, but possibilities in immunocompromised individuals or critically ill patients might include systemic infections.
Long-Term Effects: Long-term effects are not fully established.
Contraindications
- Hypersensitivity to any component of the product.
- Critically ill patients (due to a potential risk of infection, especially with S. boulardii).
- Patients with a central venous catheter (particularly for S. boulardii, which can cause fungemia).
- Short bowel syndrome.
- Immunocompromised individuals.
- Severe gastrointestinal conditions (consult physician).
Drug Interactions
This combination may interact with certain medications, particularly antibiotics. Antibiotics can reduce the effectiveness of the probiotics. It’s generally advisable to take probiotics a few hours before or after antibiotics.
Pregnancy and Breastfeeding
Consult with a doctor before using during pregnancy or breastfeeding. While generally considered safe, individual risk factors should be assessed.
Drug Profile Summary
- Mechanism of Action: Restores and maintains gut flora balance, suppressing harmful bacteria and promoting beneficial bacteria growth.
- Side Effects: Generally well-tolerated, with some potential for mild gastrointestinal issues such as gas, bloating, and nausea.
- Contraindications: Hypersensitivity, critically ill patients, central venous catheter, short bowel syndrome, severely immunocompromised.
- Drug Interactions: Antibiotics.
- Pregnancy & Breastfeeding: Consult a physician.
- Dosage: Varies; up to 9 tablets/capsules per day for adults, as directed by physician. Pediatric dosage individualized.
- Monitoring Parameters: Monitor for improvement in gastrointestinal symptoms and for any adverse effects.
Popular Combinations
This combination is often prescribed alone.
Precautions
Standard hygiene precautions are necessary, especially in individuals with a central venous catheter, to minimize the risk of infection.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bacillus mesentericus + Clostridium butryricum + Lactobacillus Sporogenes + Saccharomyces boulardii + Streptococcus faecalis?
A: The typical adult dosage can range up to 9 capsules/tablets per day or as prescribed. Pediatric dosing needs to be individualized.
Q2: Can this combination be used in children?
A: Yes, but the dosage should be determined by a healthcare professional.
Q3: What are the most common side effects?
A: Common side effects are generally mild and can include gas, bloating, abdominal discomfort, nausea, and diarrhea.
Q4: Are there any serious side effects?
A: Serious side effects are rare, but infection can be a concern in immunocompromised individuals or those who are critically ill.
Q5: Can this product be taken with antibiotics?
A: While not contraindicated, it’s advisable to take the probiotic a few hours before or after the antibiotic dose to prevent the antibiotic from affecting the beneficial bacteria.
Q6: Is it safe to use during pregnancy or breastfeeding?
A: Consult with a doctor before using during pregnancy or breastfeeding.
Q7: How should this product be stored?
A: Store in a cool, dry place, below 25°C or as indicated on the product packaging.
Q8: How long should treatment continue with this combination?
A: The duration of treatment should be as advised by your doctor and depends on the specific condition.
Q9: What if I miss a dose?
A: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.
Q10: Can this probiotic be used in patients with IBD?
A: Studies suggest that probiotics, in general, may be beneficial in maintaining remission in ulcerative colitis, a type of IBD. However, it’s essential to discuss with a gastroenterologist about whether this specific combination is appropriate for an individual’s IBD case.
