1. Service name and general information
1.4 Description — TransferBiome is an orally administered human microbiota transplantation (MT) service that offers a versatile solution for the effective treatment of chronic inflammatory bowel diseases (IBD) and other conditions associated with dysbiosis. In the long term it supports the maintenance of a balanced gut flora. It can be prescribed exclusively for patients who have successfully passed the compatibility test — for them it is produced from a dedicated lot assigned to their patient ID.
2. Indications, active substance, mechanism of action
2.1 Indications
For the treatment of chronic inflammatory bowel diseases (IBD) involving a shift in the balance of gut bacteria, or of other conditions demonstrably associated with dysbiosis. Before every administration, a FindBiome compatibility test of identical composition is recommended. The selected LOT is reserved for the patient for the duration of the treatment; if needed, a “booster” therapy may be carried out.
2.2 Active substance
Standardized microbiota suspension derived from the human large intestine, in lyophilized form, from strictly screened human donors. Manufacturing is carried out in compliance with strict quality and safety requirements.
2.3 Mechanism of action
A diverse community of living gut microorganisms from the stool of healthy, screened donors. After intake it colonizes the patient's gastrointestinal tract and restores microbial diversity and balance, which curbs the overgrowth of pathogenic bacteria — such as C. difficile — in the intestine.
3. Administration, packaging, storage, dosage
3.1 Method of administration
Orally, on an empty stomach, with plenty of liquid, without chewing or opening the capsule. Drink further generous amounts of liquid 30 minutes after taking it. In the morning, on an empty stomach; must not be taken together with alcoholic or hot drinks.
3.2 Packaging
Dark glass container (light protection). Each container holds 30 or 60 capsules — depending on the protocol, 15/30 or 20/60 daily doses. The exact regimen is determined by the treating physician. Tamper-evident seal, child-resistant closure where required. The label states the name of the service, the capsule count, the lot 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): sealed and protected from light, up to 20 years.
Store tightly closed, in an upright position; avoid frequent opening and closing.
3.4 Dosage
“Flooding” protocol: 1–3 capsules per day for 60 consecutive days. It is recommended to start treatment with 2 capsules; if symptoms do not decrease, the dose may be increased by 1 capsule every 10 days. Above 5 capsules/day no further improvement is expected — at that point, repeating the compatibility test is recommended.
3.5 Tapering off
In case of frequent relapses, taper off gradually with close clinical monitoring. On relapse, the maximum daily dose may be repeated; after the second treatment period, selecting 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 use
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 distributor agreements and local regulations. In moderately severe cases, the average treatment duration after the compatibility test, without tapering off, is 60 days.
5.2 Volume discounts — Volume discounts can be provided for large orders.
5.3 Product bundles — Minimum 30 capsules, sufficient for a treatment period of at least 20 days (protocol-dependent).
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 antibiotic therapy at least 48 hours before TransferBiome 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 immunocompromised patients. Pregnancy/breastfeeding: limited data, only after medical assessment. 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 proteins, with regular medical check-ups.
7.2 Serological testing
At least two serological tests, 8 weeks apart: HIV 1–2, Hepatitis A/B/C/E, Treponema pallidum (syphilis), inflammatory markers. Only donors who are 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 → lyophilizate → 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, with 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). EU regulatory authorities are expected to finalize the classification by the end of 2026.
9.2 Prescription and dispensing — Exclusively 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 products; it helps to connect donors and recipients by providing professional medical services. The capsules are provided as a service under TEÁOR code 869015 of the SCPA 2008 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.