1. Service name and general information
1.4 Description — AutoBiome is an orally administered autologous microbiota transplantation (aMTT) service that makes it possible to store an individual's earlier, healthy gut microbiota and, if needed, to restore it later. The stool is collected at a young age or in an ideal state of health, and then returns to the patient in freeze-dried form, enclosed in special capsules. This is the most personalized and safest form of restoring one's own gut flora.
2. Indications, active substance, mechanism of action
2.1 Indications
For individuals in excellent health in whom circumstances damaging the balance of the gut microbiota are likely to arise (prolonged antibiotic therapy, oncological or surgical intervention, “exotic” travel, high-risk occupation, peak-form timing in athletes). It is important that the patient has a healthy microbiota at the time of collection — so that later, with their own, guaranteed compatible preparation, they can achieve a faster recovery.
2.2 Active substance
A standardized microbiota suspension of human colonic origin in freeze-dried form, from strictly controlled human donors. Manufacturing is carried out in compliance with strict quality and safety requirements.
2.3 Mechanism of action
A diverse, living community of gut microorganisms from the stool of healthy, screened donors. After administration it colonises the patient's gastrointestinal tract and restores microbial diversity and balance, which curbs the overgrowth of pathogenic bacteria — C. difficile among them.
3. Administration, packaging, storage, dosage
3.1 Method of administration
Orally, without chewing or opening, on an empty stomach, with plenty of fluid. 30 minutes after taking it, drink further ample fluids. In the morning, on an empty stomach; must not be taken together with alcoholic or hot drinks. Collection is carried out with the enclosed AutoBiome Stool Collection Kit.
3.2 Packaging
Dark glass container (light protection). Each container holds 60 capsules — 20 daily doses, one pack unit. The standard package is 6 units (6×60 capsules), for six full treatment periods. Tamper-evident seal, child-resistant closure where required. The label states the name of the service, the capsule count, the batch number, the expiry date and the storage instructions.
3.3 Storage
- Room temperature (max 25°C): unopened, max. 6 months (180 days).
- Refrigerated (+4…+8°C): up to 24 months in a closed, dark container.
- Deep-frozen (below –20°C): up to 20 years, sealed and protected from light.
Store tightly closed, in an upright position; avoid frequent opening and closing.
3.4 Dosage
2 capsules per day, generally for about 15 days. The exact dosage and duration are determined by the treating physician, adjusted to the patient's condition.
3.5 Tapering
In case of frequent recurrence, gradual tapering with close clinical monitoring. On recurrence the maximum daily dose may be repeated; after the second treatment period, choosing a new LOT is recommended. Follow-up within 1–2 weeks after the last dose.
4. Benefits
4.1 Non-invasive administration
The orally administered capsules offer a minimally invasive alternative to traditional MTT methods (colonoscopy, enema), reducing discomfort and risks.
4.2 High efficacy
According to clinical research, MTT capsules significantly reduce the recurrence rate of C. difficile by restoring microbial diversity.
4.3 Ready-to-use therapy
A fully prepared, rigorously tested capsule system — no on-site stool processing, donor screening or complicated preparation.
4.4 Convenient administration
Easy to store, can be administered in an outpatient setting, and improves patients' adherence to therapy.
5. Pricing
5.1 Prices — The final price depends on the agreements concluded with the intermediary healthcare institutions and on local regulations. A discount may be granted for bulk orders from police, military or high-risk services.
5.2 Volume discounts — A volume discount may be granted for bulk orders.
5.3 Product packages — A minimum of 6×60 capsules (6 pack units), which, depending on the dry matter content of the donation, is sufficient for six complete treatments.
6. Safety, interactions, side effects
6.1 Donor screening and safety
The human microbiota undergoes thorough screening in accordance with the applicable guidelines (EMA, WGO, EAGEN, local authority). Strict microbiological, serological and parasitological tests; GMP-compliant manufacturing with numerous quality control points.
6.2 Drug interactions
Antibiotics: may reduce efficacy — completing the AB therapy at least 48 hours before AutoBiome is recommended. Probiotics: to be avoided during the therapy, except on the advice of a specialist.
6.3 Known side effects
Common, mild: gastrointestinal discomfort, bloating, flatulence, diarrhoea or constipation — usually transient. Rare, serious: infection or allergic reaction — requires immediate medical evaluation.
6.4 Warnings
Increased monitoring in immunodeficient patients. Pregnancy/breastfeeding: limited data, only after medical consideration. Contraindication: severe active GI disease (toxic megacolon, fulminant colitis), suspected bloodstream infection.
7. Manufacturing process and quality control
7.1 Donor eligibility
Every donor undergoes a comprehensive medical examination (medical history, physical examination, diagnostic tests). A diet containing antibiotic-free animal protein, regular medical check-ups.
7.2 Serological tests
At least two serological tests, 8 weeks apart: HIV 1–2, Hepatitis A/B/C/E, Treponema pallidum (syphilis), inflammatory markers. Only donors negative on every repeated test are eligible.
7.3 Microbiological testing of the donation
Multiplex PCR + traditional methods — Salmonella, Shigella, Yersinia, Campylobacter, pathogenic E. coli groups, Clostridioides, Vibrio, parasites, viruses (noro, rota, SARS-CoV-2), H. pylori, multi-resistant organisms (MRSA, VRE, ESBL, CRE). Only pathogen-free samples are used.
7.4–7.5 Processing & excipients
Bacterial suspension → lyophilisate → encapsulation. Excipients: potato starch (Amylum solani), inulin (chicory), B6 (pyridoxal-5'-phosphate), B12 (cyanocobalamin), B9 (folic acid).
7.6–7.9 LOT identification & QA
Every batch receives a unique LOT identifier with full traceability. Mandatory tests before release (purity, viable bacterial count, active substance content). Continuous GMP compliance, investigation of every OOS result.
8. Special populations
8.1 Elderly patients
Because of frequent comorbidities and polypharmacy, increased caution and closer monitoring are required.
8.2 Paediatric use
At present no circumstance is known that would contraindicate the use of MTT in children under 18 years of age.
9. Regulatory status
9.1 Classification — Medical laboratory service (869015). The EU regulatory authorities are expected to finalize the classification by the end of 2026.
9.2 Prescription and dispensing — Only under the supervision of a qualified healthcare professional.
9.3 Pharmacovigilance — All suspected side effects must be reported to the competent authority (FDA, EMA or local body).
Please note that MicroBiome Bank does not sell a product, but helps to connect donors and recipients by providing professional medical services. We provide the capsules as a service, under number 869015 of the SCPA 2008 (TEÁOR) classification (Medical laboratory services). The contents of the capsules remain the property of the donor, encumbered with the costs of the associated medical services, until the recipient has paid for them in full. The fantasy names of the services serve to make them easier to remember.