Participation in the Pet FMT Project

Introduction

The Pet FMT Project

The Pet FMT Project is a unique project in Europe, open to all owners of dogs and cats with chronic enteropathy and atopic dermatitis and to their veterinarians. The literature has shown that chronic enteropathy and atopic dermatitis are normally associated with an imbalance of the intestinal microbiome (dysbiosis). Through the Pet FMT Project, it is possible to access fecal microbiome transplantation (FMT) for your pet. The treatment aims to reduce and/or eliminate dysbiosis, restoring the microbiome towards a state of balance. This should lead to improvements in the animal's health. At the same time, participants contribute to the growing body of knowledge on FMT in dogs and cats and to the goal of making this approach increasingly effective, precise, and accessible to those who can benefit from it.

The objectives of the project are:

1. To restore the balance (eubiosis) of the recipient's intestinal microbiome by administering fecal material, and thereby improve the animal's wellbeing.

2. To collect data on the recipient's microbiome before and after fecal transplantation in order to study and understand the rebalancing dynamics and subsequently define targeted and personalised FMT protocols.

The Pet FMT Project is a research project approved by the Animal Welfare Body of the University of Padua (OPBA) under protocol no. 213810 dated 06/10/2025, concerning chronic enteropathy, and protocol no. 58560 dated 05/04/2023, concerning atopic dermatitis.

The microbiome (or microbial flora)

The microbiome is made up of trillions of microorganisms that coexist with a living organism (called the host), such as humans, dogs, cats and other animals. They are fundamental to the health of their host: they are involved in building the body, releasing molecules and signals that direct organ growth; they educate the immune system, teaching it to distinguish friends from enemies; they influence the development of the nervous system and behaviour because they interact with the metabolism, the immune system and the nervous system; they produce useful substances, eliminate harmful ones and protect against pathogens. The interaction between host and microbes is beneficial when the system is in balance, and harmful when it is not. 95% of the microorganisms in dogs and cats reside in the intestine and make up the intestinal microbiome; microbes are incorporated into the fecal mass during transit through the intestine and expelled, forming the fecal microbiome.

Fecal microbiome transplantation (FMT)

Fecal microbiome transplantation (FMT) within the Pet FMT Project consists of the transfer of intestinal microbes through the recipient's ingestion of capsules containing extracts filtered from feces donated by a healthy individual, over a defined period. The transfer takes place via oral administration of capsules containing lyophilised microbes. It is therefore a transplant in the broad sense, since, unlike classic transplants:

• it is not invasive

• it does not cause rejection problems

• ingestion of feces is a natural act among animals

• the material does not come from a deceased organism or one that has been deprived of it

• the material is a physiological and abundant by-product

FMT is currently used in veterinary medicine at a research level. In humans, it is already used clinically in cases of antibiotic-resistant Clostridioides difficile infections, a potentially lethal infection that FMT resolves in 90% of cases. Recently, the sale of fecal material has been approved for this application in Australia and the United States. In addition, over 400 clinical trials are registered evaluating FMT for rebalancing the microbiome in various inflammatory and immune-mediated diseases (Crohn's disease, ulcerative colitis, atopic dermatitis, diabetes, obesity, anxiety and depression, Parkinson's disease, autism, cancer, rheumatoid arthritis, asthma and allergies).

Chronic enteropathy and atopic dermatitis in dogs and cats are traditionally treated with dietary changes, probiotics, antibiotics and immunosuppressants. However, the disease often does not resolve and the animal periodically suffers from episodes of diarrhoea, vomiting and weight loss in the case of chronic enteropathy, or itching and skin manifestations in the case of atopic dermatitis. It is scientifically proven that chronic enteropathy and atopic dermatitis are associated with a microbiome imbalance; in this context, antibiotics, one of the most frequent interventions, can keep pathogens under control but at the same time alter the composition of the microbiome, exacerbating the problem in the long term. Conversely, FMT seeks to correct the imbalance by providing a healthy microbiome in functional and structural balance. Supporting evidence grows every day.

The goal of FMT is to restore eubiosis, but the path to achieving this result is currently unpredictable, both in terms of timing and outcome. Microbes are only one part of the system — the part we can modify with the transplant — but they cannot be separated from the rest of the organism. The response therefore depends on the severity of the animal's health condition, any compromise of organs and tissues, the duration of the disease, the age of the animal, the cause of the dysbiosis, and other factors whose role is not yet clear. In some cases the response is rapid and definitive, in others it takes months and multiple administrations, and in others there is no response at all. Current data indicate that approximately 80% of chronically enteropathic animals benefit from the first transplant cycle; about half require subsequent cycles. Data on atopic dermatitis are not yet available. The PRE and POST FMT microbiome tests, included in the project, allow the evolution of the microbiome to be assessed throughout the process.

The FMT procedure is very straightforward: after careful selection of the healthy donor, who undergoes a medical examination and targeted laboratory tests to confirm the absence of pathogens and transmissible diseases, the collected material is processed in the laboratory, lyophilised and encapsulated. Each batch is checked in terms of microbial composition. Once all checks are complete and after a quarantine period during which the donor is re-evaluated, the material is provided exclusively with the consent and guidance of the trusted veterinarian to the owner, who administers it to the animal: one capsule per day for the duration of the treatment, generally 30 days, taken whole directly or hidden in food, unless the veterinarian advises otherwise. In the context of chronic enteropathy treatment, capsules containing lyophilised fecal material may come from a single donor or from a combination of multiple donors (multi-donor). The assignment of the batch to each individual animal will be carried out through a randomisation procedure performed by EuBiome staff. The attending veterinarian and the owner will not be informed of the type of batch assigned (single donor or multi-donor), as it will not be possible to determine the composition of the administered batch from the packaging.

The project involves the collection of a small amount of fecal material before and after treatment, on which the animal's microbiome analysis is performed. At the time of collection, the veterinarian provides information on the animal's health status. The PRE and POST treatment analyses are compared, and the result is reported in the Pet FMT Report, which is delivered to the Veterinarian and the Owner at the end of the treatment

Project Limitations

• Despite the numerous evidences of FMT's efficacy and safety, current knowledge of its mechanisms of action is based on limited scientific literature. A single treatment may therefore not be sufficient to achieve balance and health. A recent scientific article on 41 dogs reports an average of 3 treatments and the observation that the lower the CCECAI — an indicator of chronic enteropathy severity — the more likely a response to fecal transplantation (Toresson L. et al. Vet. Sci. 2023). The new microbiome may not engraft, or may only partially engraft. The reasons for this are currently unknown. The FMT Report, produced using PRE and POST-FMT microbiome analyses together with the evolution of symptoms, will provide guidance on whether it is appropriate to continue with treatment.

• Donor selection based on the principle of the "HEALTHY" donor does not guarantee the success of FMT, as it has recently been scientifically demonstrated that the efficacy of FMT may depend on the microbial composition of both the donor and the recipient, though the modes of interaction between these are not yet known. The choice to administer multi-donor batches is based on the hypothesis that lyophilised fecal material obtained from multiple donors is more effective at restoring microbiome eubiosis than material from a single donor, as it increases the number of strains delivered and therefore the likelihood of stable engraftment of new microbial species.

• In the screening of the "healthy" donor, classical microbiological analysis and analysis of the microbial composition of the feces using molecular biology techniques including quantitative PCR and 16S-NGS sequencing do not allow all potential pathogens to be detected with certainty. It should be noted that most pathogens are pathogenic depending on the host in which they are found.

Risks of FMT

Multiple studies in humans and animals have shown a high level of safety and efficacy of FMT, which nonetheless remains experimental.

A review study of the human literature (Marcella et al. 2020) examining over 4,200 human patients undergoing FMT reports that 19% of patients experienced mild side effects (diarrhoea, vomiting, abdominal pain, flatulence that resolve spontaneously within a few days), while 1.4% experienced serious adverse events (infections and hospitalisation). In humans, one case of mortality attributed to FMT is reported, linked to inadequate donor selection — the donor turned out to be an asymptomatic carrier of a multi-antibiotic-resistant pathogen which, in a severely debilitated patient, took over and could not be eradicated by antibiotics. The study also highlights that side effects occur mostly in patients with damaged intestinal mucosa. No long-term adverse effects are currently known, but in general, complications may include, but are not limited to:

• Transmission of infectious organisms (bacterial, viral, fungal, parasitic) contained in the feces;

• Increased colitis activity in patients with underlying inflammatory bowel disease;

• Theoretical increased risk of developing diseases that may be associated with the donor's intestinal bacteria (obesity / metabolic syndrome, autoimmune conditions, allergic / atopic disorders, neurological disorders, malignancies).
  

In dogs and cats, the literature reports no serious adverse effects linked to FMT, although the number of cases is much more limited than in humans. Mild adverse effects (occasional episodes of diarrhoea, vomiting, loss of appetite, lethargy) are possible but negligible, as they typically resolve within 1–2 days.

To avoid serious adverse effects, EuBiome has implemented all the most appropriate procedures offered by current knowledge. In particular, donors who do not meet the requirements defined by our protocol are excluded: age between 1 and 6 years, no gastrointestinal problems in the last six months or any other pathology, no antibiotics or at most one short course completed more than six months before the start of the evaluation, microbiome not comparable to the healthy reference population, and microbiological analyses indicating the presence of antibiotic-resistant pathogens or toxin carriers. These investigations are repeated on the batch before release. A recent comparative analysis (Laperrousaz et al., 2024) highlighted a favourable benefit-risk ratio of multi-donor versus single-donor material in the treatment of ulcerative colitis in humans. It should be noted, however, that such evidence derives primarily from studies in human medicine, and that in veterinary medicine, data are currently being collected and evaluated.

In the event of side effects, it is important to discontinue the treatment, contact your veterinarian promptly, and report them to EuBiome, noting them in the diary and when completing the POST-FMT questionnaire.

Clauses

By signing this form:

1. I certify that I am the Owner of the above-mentioned animal and that I am of legal age.

2. I understand that all dogs and cats need beneficial bacteria in their digestive system for the body to function properly. Sometimes, for a number of reasons that my Veterinarian has discussed with me, there is an imbalance of beneficial and harmful bacteria. This can cause a variety of symptoms, such as diarrhoea, vomiting, as well as itching and skin manifestations. My Veterinarian has explained that my dog/cat has been diagnosed with: chronic enteropathy and/or atopic dermatitis (sign below in the §Signatures section), which is normally accompanied by intestinal microbiome dysbiosis, and that a procedure called fecal microbiota transplantation (FMT) can rebalance the bacteria in the intestinal tract and help resolve the symptoms.

3. I understand that rebalancing the microbiome is the goal of FMT, but that the path to achieving this is currently unpredictable in terms of timing and number of administrations required.

4. I understand that the administration of the microbiome capsules does not cause any pain or stress to the animal and that the study protocol does not involve any invasive or painful procedures on the enrolled cats and dogs.

5. I confirm that I have been informed that the administration of microbiome capsules for microbiome rebalancing is an experimental treatment; as such, the treatment may not lead to microbiome rebalancing, nor to improvements in my animal's health, and/or adverse reactions may occur (see §Limitations and §Risks).

6. The risks of fecal transplantation have been discussed with me and are set out above (§Risks). I understand that complications may arise following a fecal transplant, that the list in the risks section is not exhaustive, and that there may be unforeseen risks that have not been discussed with me.
   

7. I declare that I have read and understood the main information about the "Pet FMT Project" described above, and that I have also been informed by the Veterinarian about the characteristics, objectives and any risks of the activities to be carried out within the "Pet FMT Project".

8. I confirm that I wish to carry out the fecal transplant on my animal using capsules of lyophilised fecal material provided through my Veterinarian and the "Pet FMT Project".

9. I understand that the content of the capsules may vary from batch to batch, as donors are multiple and have different microbiomes.
   

10. I confirm that I will collect the fecal material for microbiome analysis and will handle it in accordance with the instructions provided in the Pet FMT Kit.

11. I am aware that the practice of medicine is not an exact science. I acknowledge that no one has provided me with any guarantee or promise regarding the results of the treatment.

12. I understand, and hereby accept, that the Veterinarian will transmit my personal data and the identifying data of myself and my animal to EuBiome so that EuBiome may contact me to provide the necessary instructions for actual participation in the "Pet FMT Project".

13. I will inform the Veterinarian in advance, to the best of my knowledge and based on any documentation in my possession, of all pathologies, medications and healthcare treatments that my animal has received, at least in the 12 months prior to signing this form, where the Veterinarian is not already aware of these.

14. I also consent to the Veterinarian directly transmitting and updating the data and information concerning my animal's health status to EuBiome for the purposes of carrying out the research.

15.  For the purposes of participation in the Pet FMT project, I agree to bear the cost of the "Pet FMT Kit", as communicated to me by my veterinarian.

16. I understand that the Pet FMT Kit is non-refundable.

17. Throughout the entire period of my animal's participation in the "Pet FMT Project", both before and after treatment, I agree to periodically communicate my animal's health status by responding to the PET FMT Diary email and any other questionnaires submitted to me.

18. I understand that I am free to withdraw from the Pet FMT Project at any time, without subjecting my animal to any treatment. In such a case, however, I undertake to immediately inform the Veterinarian and/or EuBiome of this decision.

19. I understand, and hereby accept, that my personal data and those of my animal will be used for the purposes of relevant research (including their transfer to appropriate bodies, laboratories, and companies for the intended purposes, in particular for scientific publication).

20. I understand and ACCEPT/DO NOT ACCEPT (sign in the §Signatures section) that my animal's history and data may be used for the purpose of disseminating and promoting the Pet FMT Project (through videos, articles, presentations, publications in the press and on social media). This authorisation may be withdrawn at any time by sending an email to info@eubiome.it

21. I acknowledge that this form has been explained to me and that I understand its content. I have had the opportunity to ask questions and all my questions have been answered to my satisfaction.

22. I finally confirm that I have read, understood and accepted the data processing information set out below (sign in the §Signatures section).
    

Data Processing Information

This notice is provided to Owners who intend to participate in the Pet FMT Project and describes how personal data is managed.

Pursuant to Art. 13 of Regulation (EU) 2016/679 of the European Parliament and of the Council (hereinafter also referred to as the "GDPR Regulation"), and in accordance with Legislative Decree 169/2003 (Privacy Code) as amended and supplemented, with regard to the personal data that will be accessed in the performance of the assigned task, the following is communicated.

1. Data Controller and Data Protection Officer

The Data Controller is Eubiome Srl, headquartered in Padua, Piazza Luigi da Porto, 20, 35131.

The Controller can be contacted by email: direzione@eubiome.it  - tel. +39 349 3780839963.

 The Controller has not appointed a Data Protection Officer (DPO).

2. Type of data collected

We collect the personal details of the animal's owner (first name, surname, date and place of birth, physical address, nationality, province and municipality of residence, landline and/or mobile phone number, fax, tax code, email address).

3. Purpose of processing

Your personal data will be processed exclusively for the purposes of scientific research in the healthcare field, and in particular for the purposes of the "Pet FMT project", for tax and communication purposes related to EuBiome's activities, using both paper and digital storage/archives, and with the specific adoption of a logic designed to allow access and use only by operators involved in the research specifically assigned to the activities described above, guaranteeing the confidentiality of sensitive data and compliance with current privacy regulations, in particular pursuant to EU Regulation no. 2016/679 and Legislative Decree 196/2003.

4. Legal basis for processing

The legal basis for the processing of the personal data indicated above is the necessity to implement the Pet FMT Project; therefore, the provision of data for this purpose is mandatory, and any failure or partial provision may make it impossible to carry out, or may cause the suspension or even termination of, the service itself.

5. Data retention

Your personal data, processed for the purposes indicated above, will be retained for the duration of the Pet FMT Project and, subsequently, for as long as the Veterinarian and Eubiome Srl are subject to retention obligations for tax purposes or for other purposes provided for by law or regulation.

6. Data communication

Your personal data may be communicated to third parties solely and exclusively for the purposes of services functional to those strictly necessary and/or connected to the implementation of the Pet FMT Project, and/or as required by specific legal obligations.

7. Profiling and data dissemination

Your personal data are not subject to dissemination nor to any entirely automated decision-making process, including profiling.

8. Rights of the data subject

Among the rights recognised to the "Data Subject" by the EU GDPR Regulation are the rights to:

• request from the data controller access to the personal data and information collected and processed; the rectification of inaccurate data or the integration of incomplete data; the erasure of personal data concerning them (upon the occurrence of one of the conditions indicated in Art. 17, paragraph 1 of the GDPR and in compliance with the exceptions set out in paragraph 3 of the same article); the restriction of the processing of their personal data (upon the occurrence of one of the cases indicated in Art. 18, paragraph 1 of the GDPR);

• request and obtain from the data controller — in cases where the legal basis for processing is a contract or consent, and processing is carried out by automated means — their personal data in a structured and machine-readable format, also for the purpose of transmitting such data to another data controller (the so-called right to data portability);

• object at any time to the processing of their personal data where particular circumstances relating to them arise;

• withdraw consent at any time, limited to cases where processing is based on their consent for one or more specific purposes and concerns common personal data or special categories of data. Processing based on consent and carried out prior to its withdrawal retains its lawfulness;

• lodge a complaint with a supervisory authority (Italian Data Protection Authority – www.garanteprivacy.it).