1. Service name and general information
1.4 Description — HospBiome is an orally administered human microbiota transplantation (MT) service developed to restore healthy gut microbiota in patients with recurrent Clostridioides difficile (rCDI) infection. A high-density preparation optimised for hospital treatment. Originally developed as part of the TransferBiome protocol.
2. Indications, active substance, mechanism of action
2.1 Indications
For the treatment of C. difficile infection (CDI) in hospitalised patients. Particularly recommended if antibiotic therapy has not been effective or if CDI has already recurred several times.
2.2 Active substance
Standardised microbiota suspension derived from the human colon, 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 administration it colonises the patient's gastrointestinal tract and restores microbial diversity and balance, which suppresses the overgrowth of pathogenic bacteria — such as C. difficile — in the gut.
3. Administration, packaging, storage, dosage
3.1 Method of administration
Orally, on an empty stomach, with plenty of fluid, without chewing or opening the capsules. Via a nasogastric tube as well: the capsules may be opened, their contents emulsified in a neutral liquid (water, cold tea, plain yoghurt) and administered through the tube. In the morning, on an empty stomach; not to be taken together with alcoholic or hot drinks.
3.2 Packaging
Dark glass container (light protection). Each container holds 5 capsules — the recommended daily dose, one packaging unit. Six glass containers make up one treatment unit, sufficient for the complete treatment of one patient. Tamper-evident seal, child-resistant closure where required. The label states the service name, 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): in a closed, dark container, up to 12 months.
- 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
5 capsules daily, usually for about 6 days. Treatment begins with HospBiome 5(L) (min. 3 days). If bowel movements decrease, switch to HospBiome 5(XX) until the symptoms resolve. The exact dosage is determined by the treating physician.
3.5 Tapering off
In case of frequent recurrence, taper gradually with close clinical monitoring. On recurrence 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
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, 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 Pricing — The final price depends on distributor agreements and local regulations. The list price is defined per daily treatment unit.
5.2 Volume discounts — A volume discount can be provided for large orders.
5.3 Product packages — Packs containing a minimum of 120 treatment units, sufficient to treat 20 patients.
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 HospBiome 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 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 protein, 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 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 Prescribing and dispensing — Only under the supervision of a qualified healthcare professional.
9.3 Pharmacovigilance — Any suspected adverse reaction must be reported to the competent authority (FDA, EMA or local body).
Please note that MicroBiome Bank does not sell products, but facilitates the connection between donors and recipients by providing professional medical services. The capsules are provided as a service under number 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.