1. Name of the service and general information
1.4 Description — UltraBiome is an orally administered human microbiota transplantation (MT) service developed to enhance physical performance and to make it possible to take up exercise or to continue it at a higher intensity. It is based on carefully screened bacterial mass from ultra-endurance athletes, which supports metabolic and energy-producing processes and exercise in performance zone 2. For patients who have undergone a medical assessment only.
2. Indications, active substance, mechanism of action
2.1 Indications
For individuals whose goal is to increase their physical performance and to enhance their training load and endurance. With the selected LOT it can be repeated as a “booster” therapy where needed, supporting continuous training goals.
2.2 Active substance
Standardised microbiota suspension of human colonic origin in lyophilised 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 live gut microorganisms from the stool of healthy, screened donors. After intake it colonises the patient's gastrointestinal tract and restores microbial diversity and balance, which pushes back the overgrowth of pathogenic bacteria — such as C. difficile — in the gut.
3. Administration, packaging, storage, dosage
3.1 Method of administration
Orally, without chewing or opening, on an empty stomach, with plenty of fluid. Via a nasogastric tube as well: the capsules can be opened and their contents emulsified in a neutral liquid. 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 capsules — a 30-day supply, one packaging unit. The exact schedule is determined by the treating physician or sports physician. Tamper-evident seal, child-resistant closure where needed. The label states the name of the service, the number of capsules, 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 12 months in a closed, dark container.
- Deep-frozen (below –20°C): sealed and protected from light, up to 20 years.
Store tightly closed and upright; avoid frequent opening and closing.
3.4 Dosage
A “flooding” protocol, e.g. over 6 months, 1–2 capsules a day (usually 60–180 days). It is recommended to start treatment with 1 capsule. The exact dosage is determined by the treating physician.
3.5 Tapering off
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 the selection of a new LOT is recommended. Follow-up within 1–2 weeks after the last dose.
4. Benefits
4.1 Non-invasive administration
Orally administered capsules offer a minimally invasive alternative to conventional 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, strictly tested capsule system — no on-site stool processing, donor screening or complex preparation.
4.4 Convenient administration
Easy to store and to administer in an outpatient setting, it improves patients' therapeutic adherence.
5. Pricing
5.1 Prices — The final price depends on distributor agreements and local regulations. In obesity/type II diabetes the average treatment time after the build-up is 6 months, which may be followed by a further 6 months subject to a specialist decision.
5.2 Volume discounts — A volume discount can be provided for large orders.
5.3 Product packages — Minimum 30 capsules, a one-month supply. UltraBiome donors are exclusively verified elite athletes (swimming min. 10 km, running min. 50 km, cycling min. 200 km).
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 antibiotic therapy at least 48 hours before UltraBiome is recommended. Probiotics: should be avoided during therapy, except on the recommendation 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 consideration. Contraindications: 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 tests
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 + conventional 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, 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 finalise 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; it helps to connect donors and recipients by providing professional medical services. The capsules are provided as a service, under 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 invented names of the services serve to make them easier to remember.