FindBiome capsule

2.1 Indications

Selection of the most compatible donation graft with the most suitable batch (LOT) number. As a result, TransferBiome therapy can be carried out with high efficacy, ensuring optimal microbial colonisation.

2.2 Active substance

Standardised microbiota suspension of human colonic origin in lyophilised form, from rigorously screened human donors. Manufacturing takes place 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 administration it colonises the patient's gastrointestinal tract and restores microbial diversity and balance, which keeps pathogenic bacteria — such as C. difficile — from overgrowing.

3.1 Method of administration

Orally, on an empty stomach, with plenty of fluid, without chewing or opening the capsule. 30 minutes after taking it, drink further generous amounts of fluid. In the morning, on an empty stomach; it must not be taken together with alcoholic or hot drinks.

3.2 Packaging

Dark glass container (light protection). Each container holds 15 capsules — a 5-day supply, one pack unit. 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): in a closed, dark container, up to 24 months.
• 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

Compatibility test protocol, min. 32 days. Four cycles (4 pack units), each consisting of a testing phase (5 days, 3 capsules per day) and a tapering phase (3-day break). Each cycle uses a preparation with a new LOT number. Keeping a food and symptom diary is mandatory — without it the test cannot be evaluated.

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.

4.1 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 use

Easy to store, can be administered in an outpatient setting, and improves patients' treatment adherence.

5.1 Price setting — The final price depends on distributor agreements and local regulations.

5.2 Volume discounts — A volume discount can be provided for large orders.

5.3 Product packages — 4×15 capsules, sufficient to carry out one complete compatibility test.

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 FindBiome is recommended. Probiotics: should 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 consideration. Contraindication: severe active GI disease (toxic megacolon, fulminant colitis), suspected bloodstream infection.

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, multidrug-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.

8.1 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.

9.1 Classification — Medical laboratory service (869015). EU regulatory authorities are expected to finalise the classification by the end of 2026.

9.2 Prescription and dispensing — Exclusively 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).