1. Service name and general information
1.4 Description — DiffBiome is an orally administered human microbiota transplantation (MT) service developed to restore healthy gut microbiota in patients with recurrent Clostridioides difficile (rCDI) infection. Every capsule contains a standardised gut microbiota graft. It was 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 patients cared for at home. Particularly recommended if antibiotic therapy has not been effective or if CDI has already recurred several times.
2.2 Active substance
A standardised microbiota suspension of human large-intestinal 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 ingestion it colonises the patient's gastrointestinal tract and restores microbial diversity and balance, which keeps the overgrowth of pathogenic bacteria — such as C. difficile — in check.
3. Administration, packaging, storage, dosage
3.1 Method of administration
By mouth, without chewing or opening the capsule, on an empty stomach, with plenty of fluid. Drink further generous amounts of fluid 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 capsules — a 10-day supply, one packaging unit. 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): up to 24 months in a closed, dark container.
- Frozen (below –20°C): up to 20 years, sealed and protected from light.
Store tightly closed and upright; avoid frequent opening and closing.
3.4 Dosage
3 capsules daily, usually for about 10 days. Treatment starts with DiffBiome 30(V) (min. 10 days). If stool frequency does not decrease, DiffBiome+ follows until the symptoms resolve. The exact dosage is determined by the treating physician.
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
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 Price setting — The final price depends on distributor agreements and local regulations. In moderately severe cases, 30–60 capsules is the average volume.
5.2 Volume discounts — A volume discount can be granted for large orders.
5.3 Product bundles — Minimum pack size of 30 capsules, sufficient for one full course of treatment.
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 DiffBiome 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. 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 with 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 samples free of pathogens 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 — Every suspected side effect 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 brand names of the services are intended to make them easier to remember.