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Clostridioides (Clostridium) difficile infection treatment protocol

with normal or double density human microbiome suspension

in institutional or home care

Moving on

Reducing infections

with the right composition of microbiome extract

Clostridioides difficile is a Gram-positive anaerobic bacterium, which causes Clostridioides difficile infection (CDI). It has been recognised as a leading cause of healthcare-associated infections and a considerable threat to public health globally. CDI infection is becoming an increasingly serious health and social problem, but thanks to MicroBiome Bank, a professionally approved and effective treatment has been available in all European countries for years.

If a patient has a history of Clostridioides difficile (formerly Clostridium difficile) infection and is re-detected by laboratory diagnostic methods (Toxin A/B or C) or has symptoms of recurrence of infection as previously diagnosed, MTT is the first-line treatment of choice for this type of enteric infection, in accordance with international recommendations[1],[2].

The protocol was designed with the aim of allowing the patient to be discharged home after diagnosis, appropriate information, explanation of the treatment plan and completion of a patient consent form. Once the diagnosis has been made, treatment should be carried out as described in the protocol.

[1] https://pubmed.ncbi.nlm.nih.gov/34678515/

[2] https://pubmed.ncbi.nlm.nih.gov/32150234/

Comparative Analysis of MTT and Antibiotics

Clostridium difficile infection (CDI) poses a significant challenge in modern healthcare, requiring effective and cost-efficient treatment strategies. Below we aim to provide a comprehensive analysis of two primary treatment modalities: Microbiome Treatment Therapy by FMT and antibiotics. Traditional antibiotic therapy, while many times effective, has been linked to high recurrence rates, leading to the exploration of alternative treatments such as MTT.

MicroBiome Treatment Therapy (MTT)

Pros
Cons
  1. High Cure Rates: MTT has demonstrated superior efficacy in treating recurrent CDI, with cure rates exceeding 90%.
  2. Microbiome Restoration: MTT restores the balance of gut microbiota, promoting long-term resilience against CDI recurrence.
  3. Reduced Antibiotic Dependency: MTT reduces reliance on antibiotics, potentially mitigating antibiotic resistance concerns.
  4. Long Term Financial Benefits: MTT may have higher initial costs due to donor screening, laboratory testing, and procedural requirements, but due to its higher cure rates, application may lead to long-term cost savings by reducing the need for repeated courses of antibiotics and hospital readmissions.
  1. Limited Standardization: Due to the nature of MTT, the microbiome of each donor changes every day, every hour, and therefore, unlike drugs, it cannot be standardised. MTT lacks standardized protocols, leading to variability in clinical outcomes.
  2. Risk of Infection Transmission: There is a minimal risk of transmitting infections from the donor to the recipient, emphasizing the need for rigorous donor screening.

Antibiotics

Pros
Cons
  1. Widespread Availability: Antibiotics are readily available and can be administered orally or intravenously, ensuring ease of use.
  2. Cost-Effective: Antibiotics are generally more cost-effective in the short term compared to MTT. But this only holds until the first reoccurrence.
  1. High Recurrence Rates: Antibiotic therapy is associated with higher recurrence rates, requiring prolonged and repeated courses.
  2. Disruption of Microbiota: Antibiotics not only target the pathogen but also disrupt the healthy gut microbiota, potentially leading to dysbiosis.
  3. High Long Term Costs: Antibiotics are generally more affordable initially, but antibiotic-related complications, such as adverse reactions, recurrent infections and prolonged hospital stays for extended treatment durations as well as change of antibiotics may cause costs to escalate rapidly.

Conclusion

In conclusion both MTT and antibiotics play a crucial roles in managing CDI, each with its set of advantages and disadvantages. MTT offers superior efficacy and microbiome restoration, potentially translating into long-term financial benefits. Antibiotics, while more accessible and cost-effective initially, come with higher recurrence rates and hidden costs. For mild infections, it is in the best interest of the patient to wait. In cases where oral or iv. antibiotics is to be administered, given the price of Vancomycin, Fidaxomycin and Bezlotoxumab, the patient and the institution will experience a financial benefit when chosing MTT over standard AB therapy.[3]

[3] https://pubmed.ncbi.nlm.nih.gov/33878506/

The course of treatment

There is no significant difference in efficacy between the two routes of administration (capsule and enema), so oral administration is recommended in terms of treatment invasiveness, equipment and human resources required, as well as cost of care.[4]

Treatment plan

The dosage should always be adjusted to the symptoms: 2 capsules per day by default, 3 capsules per day in severe cases.The first treatment cycle is always 7 days and we do not recommend interrupting it. If the number of daily bowel movements decreases significantly during this period, the consistency of the stools passed improves and the number and intensity of bowel movements and cramps decreases, treatment should not be continued after day 7. Any capsules remaining from the treatment should be stored in a freezer and can be used within 24 months of opening in the event of a relapse.

Interpreting results

If the symptoms are reduced, but some elements of the symptoms persist, the treatment should be continued up to the maximum of 30 capsules per box, while increasing the dose to the maximum (3 capsules per day). No further improvement can be expected after the 15th day or after the 30 capsules have been taken and therefore a professional consultation is considered necessary before continuing treatment.

Changing donor

If the MTT with a given donation has not produced the desired result or if there is no complete remission of certain elements of the symptom complex, it is advisable to seek another donor to increase microbiome compatibility. The use of MTT from a new donor should be performed as described in the 'Treatment plan' section.

[4] https://pubmed.ncbi.nlm.nih.gov/30388112/

Precautions

Ensure that for the duration of MTT the patient:

- is not taking antibiotics or probiotics;
- should only consume antibiotic and antihelminthic-free animal protein and avoid artificial sweeteners;
- should eat foods containing live bacteria (live-flora dairy products, lacto-fermented vegetables).

Microbiome Transfer Therapy (MTT) is currently the most effective method of treating recurrent Clostridium difficile infection and is the most capable of restoring natural function. It is extremely safe when used in accordance with professional standards and MTT guidelines. The use of MTT reduces the likelihood of recurrent infections, while improving the diversity of the gut microbiome as a beneficial side effect.