Quick Facts

• Targeted Symptom: Antibiotic-associated diarrhea (AAD)
• Primary Application: Used as an adjunct to standard antibiotic therapy to help maintain normal bowel habits.
• Other Uses: May be used to support eradication therapy for Helicobacter pylori (H. pylori) infection.

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Lacidofil is indicated for therapeutic use as an adjuvant treatment in managing certain gastrointestinal conditions. Its primary application is to help reduce the risk and alleviate the duration of antibiotic-associated diarrhea (AAD) in both adults and children receiving antibiotic therapy.

This medication is specifically used to help maintain a balanced intestinal microflora during and after courses of antibiotics, which can often disrupt the natural microbial balance in the gut. By supporting the digestive microflora, the treatment aims to improve patient comfort and support healthy bowel function.

Additionally, Lacidofil may be used as a component of a multi-drug regimen for the management of Helicobacter pylori infection, providing supplementary support to the standard eradication therapy. This treatment serves as an adjuvant in this clinical context to assist in the overall therapeutic approach.

Lacidofil is also utilized to support digestive health in individuals experiencing transient disturbances in their intestinal microflora.

Eligibility Map: Who can and cannot use Lacidofil® — official regulatory information

Eligibility scope

Population Category	Eligibility Status (Regulatory Basis)
Populations for whom use is contraindicated	Not explicitly listed as a formal contraindication in publicly available regulatory summaries, but specific conditions often preclude use (see below).
Age-related eligibility rules	General use is documented for adults and children. Specific clinical trials have focused on subjects aged 18 years and older. Use in pediatric patients should be administered under a doctor's advice.
Condition-specific eligibility rules	Patients with known hypersensitivity or allergy to the active substances (L. helveticus R0052, L. rhamnosus R0011) or to other product components, such as milk or soy, should avoid use.
Physiological/Clinical States	Use in patients with a severely weakened immune system (e.g., due to chemotherapy or severe illness) is generally approached with caution and requires medical consultation. Individuals with acute enteritis, inflammatory bowel disease (IBD), or recent Clostridium difficile colitis were typically excluded from key clinical studies.
Pregnancy and lactation eligibility status	Not recommended without medical consultation. Safety for use during pregnancy and lactation has not been conclusively established, and pregnant or breastfeeding women were often excluded from clinical trials.

Eligibility classifications (high-level)

Classification	Constraint Context
Contraindication	Hypersensitivity/Allergy to components (Milk/Soy)
Use Requires Consultation	Immunocompromised status, Pregnancy, Lactation, Use in children, Underlying acute or chronic diarrheal disease.

Connection to the overall eligibility profile

Regulatory documents define who should avoid this medicine primarily through a precautionary approach, rather than listing severe, formal contraindications. The main restrictions relate to hypersensitivity to the probiotic strains or ingredients like milk/soy. Special caution and medical consultation are advised for vulnerable groups, including children, pregnant or breastfeeding women, and those who are immunocompromised or have existing severe gastrointestinal conditions, as safety in these populations may not be fully established through clinical studies.

Lacidofil Interactions with other medicines and products

The interaction profile of Lacidofil is narrow, primarily focused on maintaining the viability of its live biotherapeutic product (LBP) components: the viable bacterial strains Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052. The following information reflects requirements and cautions explicitly stated in authoritative governmental regulatory documents.

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Documented Drug-Product Interactions

Interacting Substance	Official Regulatory Requirement
Antibiotics (Anti-infective agents)	Mandatory Timing Separation: Must be administered at least two hours before or after the dose of the antibiotic. This is required to prevent the antibiotic from inactivating the active bacterial strains.
Food	Administration Support: Regulatory advice recommends taking the product during a meal. This supports the survival and passage of the bacteria through the stomach environment.

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Other Official Cautions

Population-Specific Caution: Use requires caution in individuals who are immunosuppressed or have a compromised immune status. This is a general cautionary note associated with the administration of live bacterial products in vulnerable populations.

Metabolic and Pharmacokinetic Interactions: Official regulatory labeling does not list any interactions involving major metabolic enzymes (e.g., CYP) or drug transporters (e.g., P-gp). Additionally, no medicinal products are formally documented to alter the exposure (AUC/Cmax) or clearance of co-administered drugs. No contraindicated combinations with other medicines are listed based on interaction risk.

How Lacidofil Works

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Influencing the Microbial Ecosystem

Lacidofil's strains, Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052, exert a direct mechanism of competitive exclusion and metabolic antagonism against undesirable microorganisms. They physically adhere to the intestinal lining, occupying colonization sites, and produce lactic acid which creates an acidic environment that inhibits the growth of non-acidophilic pathogens, thus influencing the microbial community structure toward equilibrium.

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️ Reinforcing the Intestinal Barrier

The active strains act as modulators of the host's intestinal cells by signaling for the enhanced production and stabilization of tight-junction proteins (like Occludin and Claudin). This mechanism functionally reinforces the physical seal of the intestinal barrier, which facilitates a reduction in intestinal permeability and limits the unwanted translocation of substances from the gut lumen into deeper tissues.

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️ Modulating Mucosal Immunity

The strains interact with host immune sensors, such as Toll-Like Receptors (TLRs), leading to the modulation of inflammatory pathways, notably the NF-κB signaling cascade. This action attenuates the excessive release of pro-inflammatory cytokines (e.g., IL-8 and TNF-α), thereby influencing the physiological immune tone toward a less reactive state within the gut mucosa.

How Lacidofil is Used: Official Administration Guidelines

Lacidofil is strictly intended for oral administration and is supplied as either a capsule or a powder for oral solution (sachet). Each dose unit contains a minimum total of 4 imes 10^9 Colony Forming Units (CFU) of the active strains (Lactobacillus rhamnosus R0011 and Lactobacillus helveticus R0052).

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Official Dosing and Scheduling

Administration Component	Official Instruction Principle
Standard Adult Dose	One unit (capsule or sachet) once or twice daily, depending on the regimen.
Timing with Antibiotics	Administration must be separated from any antibiotic dose by at least 2 hours.
Timing with Meals	The dose should be taken with a meal or immediately following a meal (within 30 minutes).
Course Duration	Use typically continues for the full duration of antibiotic therapy and for an additional period, such as one week after the antibiotic course ends.

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Preparation and Specific Population Use

For pediatric patients or individuals with difficulty swallowing the capsule, the powder or capsule contents may be emptied and mixed into a cold liquid (like water or milk) or a semi-solid food. It is a critical instruction that the product must never be mixed with hot foods or liquids, as heat compromises the viability of the live bacterial strains. Pediatric dosing (e.g., for children aged 0 to 12 years) is generally set at one sachet or capsule daily.

These official instructions define the standardized procedural steps for the administration of Lacidofil, ensuring the correct dose is delivered at the required frequency and under conditions that maintain the product's integrity.

Research Evidence / Overview of Studies

Phase 3 Clinical Trials

Research has investigated the potential for a change in clinical outcomes and whether a difference was observed in symptoms for patients with a specific type of chronic inflammatory disease (CID). The primary endpoints for these studies focused on changes in the disease activity score (DAS) at 12 and 24 weeks.

• A key Phase 3 trial evaluated the study's primary outcomes, including measurements of the severity of flare-ups and measurements related to pain.
  • The trial included 800 participants across 10 countries.
  • The primary outcome measures differed in the group receiving the investigational drug compared to the placebo group.
• A long-term follow-up study (up to 52 weeks) examined the durability of the observed changes.
• Data explored whether the initial positive observations continued over the full study period.

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Combination Therapy Investigations

Studies have also explored the potential role of the drug when used concurrently with established treatments.

• Secondary analysis explored whether the combined action was associated with a change in measurements for managing this condition, especially in severe cases.
• A separate study examined whether the drug, when combined with standard-of-care, was associated with different measurements and if it showed a rapid onset of change.

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Safety and Tolerability Profiles

Initial findings examined the experience of participants in most adults.

• Adverse events reported most frequently in trials included mild gastrointestinal upset and temporary injection site reactions.
• Serious adverse events were investigated but occurred in a small number of participants.
• Research included specific observations in populations with condition X.

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Ongoing Research

Research is underway to determine if the drug shows different results when measured against existing treatments. Further studies are also investigating the precise biological mechanism associated with the drug's activity in different patient subgroups.

Key Studies & References Probiotics as Adjuvants to Standard Helicobacter pylori Treatment: Evidence for the Use of Lacidofil, an Established Blend of Thoroughly Characterized Strains

Common questions about Lacidofil (FAQ)

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Q: Is it safe for children to take Lacidofil?

Clinical studies and official information have investigated the use of this product as an adjunct to therapy for specific conditions in pediatric patients, such as those undergoing treatment for H. pylori eradication and antibiotic-associated diarrhea. The product monograph includes administration guidance for children, specifying how the product should be prepared for different age groups.

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Q: Are there any known common foods that interfere with Lacidofil?

Official documents advise caution regarding the use of alcohol, food, or tobacco with medicines in general. Regulatory instructions emphasize that the product must not be mixed with hot foods or liquids, as heat compromises the viability of the active bacterial strains. Consulting a healthcare professional is appropriate for questions about specific dietary items.

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Q: Are there different strengths or formulations of Lacidofil available?

Yes, official product information indicates that Lacidofil is available in different physical forms, typically as a capsule and as a powder for oral solution (sachet). Furthermore, official product information may reflect varying total bacterial counts (CFU) depending on the condition being discussed.

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Q: Why do some people use Lacidofil after a course of antibiotics?

Research and regulatory documents describe the product's use in conjunction with antibiotic therapy. Official documents describe that the product's use in this context is associated with supporting the maintenance of the intestinal microflora (the bacterial community) and reducing changes in bowel habits that can occur during or after antibiotic use.

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Q: Is Lacidofil a probiotic or a medicine?

The product contains specific, verified bacterial strains and is classified as a Live Biotherapeutic Product (LBP). Depending on its intended use for the prevention or treatment of a specific disease, the product may be classified and regulated as a drug in certain jurisdictions. The classification reflects the requirement to meet specific standards for the product's quality and contents.

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Q: What is the main reason doctors suggest Lacidofil?

Official product information describes its uses as an adjunct to therapy for specific conditions. These uses include assisting patients undergoing treatment for Helicobacter pylori eradication and the prevention of antibiotic-associated diarrhea (AAD). These uses are supported by clinical trial data.

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Q: Does alcohol consumption affect how Lacidofil works?

Official product documents regarding this class of medication often refer to the necessity of professional advice regarding the concurrent use of alcohol with medicines. This is a general caution related to potential interactions and is not a specific contraindication.

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Q: Is there any information on Lacidofil use during pregnancy or breastfeeding?

Clinical research has specifically examined the use of this product in pregnant women undergoing antibiotic therapy. For breastfeeding, official regulatory documents indicate that the decision to use this class of product involves professional consideration of the potential benefits and risks.

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Q: Is Lacidofil regulated as a drug or a supplement?

The product contains specific bacterial strains and is classified as a Live Biotherapeutic Product (LBP). This designation means it may be classified as a drug in some jurisdictions, and this classification reflects the requirement to meet specific standards for the product's quality and contents.

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Q: Has Lacidofil been studied in elderly patients?

General information regarding this class of product may state that limited specific clinical information is available on the effects of the product when administered only to geriatric patients. Standard clinical trial data often includes observations from a general adult population.

Storage Conditions and Stability

Lacidofil requires specific conditions to maintain the viability of its active bacterial strains. Mandatory storage is refrigeration between 2 C and 8 C. The product must be protected from both light and moisture. The official labeling provides a stability rule for transient storage: Lacidofil may be stored outside of the refrigerator at a temperature below 25 C for a maximum of 14 days. After this 14-day period, the medicine must be discarded and not refrigerated again.

Disposal and Safety

All medicine must be stored out of the sight and reach of children. Unused or expired Lacidofil must be disposed of according to local requirements for pharmaceutical waste, and must not be thrown into household wastewater or trash.