Usage
This combination of prebiotic fructooligosaccharides (FOS) and probiotic Lactobacillus species is primarily used to maintain and restore the vaginal microbiota. It is indicated for:
- Prevention and treatment of bacterial vaginosis (BV): BV is a common vaginal infection resulting from an imbalance of the vaginal flora.
- Prevention of recurrent urinary tract infections (UTIs) in women: Some evidence suggests this combination may help prevent UTIs by promoting a healthy vaginal microbiome.
- Relief from vaginal dryness: The lactobacilli in the combination may help maintain vaginal moisture.
Pharmacological Classification: Probiotic, prebiotic
Mechanism of Action: FOS acts as a prebiotic, nourishing the probiotic Lactobacillus species. These lactobacilli colonize the vagina, produce lactic acid, and lower the vaginal pH, creating an environment that inhibits the growth of pathogenic bacteria associated with BV. The lactobacilli also form a protective barrier against pathogen adhesion.
Alternate Names
- Vaginal probiotic
- Probiotic complex
- Lactobacillus combination with FOS
Brand Names: OMNi-BiOTiC® FLORA plus, Ecotas BV
How It Works
Pharmacodynamics: FOS selectively promotes the growth of beneficial lactobacilli in the vagina. These bacteria produce lactic acid, lowering vaginal pH and inhibiting the growth of pathogenic bacteria. This promotes a healthy vaginal flora.
Pharmacokinetics: FOS is not digested in the upper gastrointestinal tract and reaches the colon largely intact. In the colon, it is fermented by the gut microbiota, particularly bifidobacteria and lactobacilli. It is primarily eliminated through fecal excretion. Orally administered lactobacilli may transiently colonize the gastrointestinal tract and contribute to a balanced gut microbiome. While oral administration can influence vaginal health, the lactobacilli are not typically detected in the vaginal microbiome after a certain period. The precise mechanism by which orally administered lactobacilli influence vaginal health requires further investigation, though it is postulated to involve modulation of the immune system and competition with pathogens in the gut.
Mode of Action: Lactobacillus species adhere to the vaginal epithelium, forming a protective barrier against pathogens. They compete with pathogens for nutrients and produce antimicrobial substances like bacteriocins.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: This combination primarily exerts its effects through pH modulation and competitive exclusion, not through direct receptor binding, enzyme inhibition, or neurotransmitter modulation.
Elimination Pathways: FOS is eliminated through fecal excretion.
Dosage
Standard Dosage
Adults: One capsule or sachet containing the specified strains and FOS once or twice daily, ideally with water after meals. The dosage may vary depending on the product and the CFU count of each Lactobacillus strain. A common dosage is 2g per sachet or capsule. For two sachets or capsules, the dosage is 4g.
Children: Use in children under 5 years is generally not recommended unless under the guidance of a healthcare professional.
Special Cases:
- Elderly Patients: No specific dosage adjustments are typically required.
- Patients with Renal Impairment: No specific dosage adjustments are typically required.
- Patients with Hepatic Dysfunction: No specific dosage adjustments are typically required.
- Patients with Comorbid Conditions: Patients with weakened immune systems (e.g., HIV, chemotherapy) or recurring infections should consult their doctor before use. Patients with inflammatory bowel disease or gut problems should also consult their doctor.
Clinical Use Cases
This combination isn’t typically indicated for conditions like intubation, surgical procedures, mechanical ventilation, or ICU use. Its primary use is for BV and UTI prevention.
Dosage Adjustments
Dosage adjustments are not typically necessary unless directed by a healthcare professional.
Side Effects
Common Side Effects
- Increased gas or bloating
- Stomach cramps
- Flatulence
Rare but Serious Side Effects
- Signs of infection (e.g., persistent cough, high fever, chills)
- Allergic reactions (rash, itching/swelling, dizziness, trouble breathing)
Long-Term Effects
No long-term adverse effects have been established.
Adverse Drug Reactions (ADR)
ADRs are rare but can include severe allergic reactions.
Contraindications
- Hypersensitivity to any ingredient, including any Lactobacillus species or FOS.
- Individuals with severely compromised immune systems (e.g., undergoing chemotherapy, organ transplant).
Drug Interactions
- Antibiotics: Antibiotics can reduce the effectiveness of probiotics. Take this product at least 2-3 hours before or after antibiotics.
- Antifungals (e.g., clotrimazole, ketoconazole, griseofulvin, nystatin): May interact with this product.
- Alcohol: Alcohol can decrease the efficacy and may cause adverse effects.
Pregnancy and Breastfeeding
This combination is generally considered safe during pregnancy and breastfeeding. However, it’s always advisable to consult a physician before use during these periods.
Drug Profile Summary
- Mechanism of Action: FOS nourishes vaginal lactobacilli, which produce lactic acid, lower vaginal pH, and inhibit pathogenic bacteria.
- Side Effects: Gas, bloating, cramps, flatulence. Rarely, allergic reactions or signs of infection.
- Contraindications: Hypersensitivity, severely compromised immune system.
- Drug Interactions: Antibiotics, antifungals.
- Pregnancy & Breastfeeding: Generally safe, consult a physician.
- Dosage: One capsule/sachet once or twice daily.
- Monitoring Parameters: Vaginal pH, signs and symptoms of BV or UTI.
Popular Combinations
Often used as a standalone product. It can potentially be combined with other probiotics, but clinical data on specific combinations is limited.
Precautions
- General Precautions: Screen for allergies and relevant medical conditions.
- Pregnant Women: Consult a physician.
- Breastfeeding Mothers: Consult a physician.
- Children & Elderly: Not recommended for children under 5 without medical advice. No specific precautions for the elderly.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Fructo Oligosaccharide + Lactobacillus crispatus + Lactobacillus gasseri + Lactobacillus jensenii + Lactobacillus rhamnosus?
A: One capsule or sachet containing the specified strains and FOS once or twice daily for adults. Dosage may vary based on product and CFU count. Consult a healthcare professional for pediatric or special population dosing.
Q2: Can this combination be used during pregnancy?
A: Generally considered safe, but consult a physician before use.
Q3: How does this combination prevent BV?
A: FOS promotes the growth of beneficial lactobacilli, which produce lactic acid and lower vaginal pH. The acidic environment inhibits the growth of bacteria associated with BV.
Q4: What are the common side effects?
A: Gas, bloating, stomach cramps, and flatulence are possible.
Q5: Are there any drug interactions I should be aware of?
A: Concurrent use with antibiotics and antifungals can reduce efficacy. Avoid alcohol.
Q6: Can this combination treat an existing BV infection?
A: It can be used as an adjunct therapy in combination with antibiotics but may not be sufficient as a standalone treatment for active BV.
Q7: How long should this product be taken?
A: Duration of use can vary. Consult a physician for guidance. One suggested duration is one month.
Q8: Can this be used to treat vaginal dryness?
A: It can potentially help with vaginal dryness by supporting a healthy vaginal flora, but it’s not a primary treatment for this condition.
Q9: Is this combination effective in preventing UTIs?
A: Some evidence suggests a benefit in UTI prevention, but more research is needed.
Q10: Can I take this with other probiotics?
A: Combining with other probiotics is possible, but clinical data on specific combinations is limited. Consult a healthcare professional.