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Safety without empty promises

How FMT safety is managed

Safety starts before the first dose: with patient assessment, strict donor selection, product quality control and follow-up after transplantation.

No medical procedure is completely risk-free. The protocol is designed to identify contraindications, reduce the likelihood of complications and recognise warning signs early.

01—04

Four safety barriers

1Patient assessment
2Donor selection
3Product control
4Follow-up

A system, not a single test

Four safety barriers

Each stage answers a different question: is the patient eligible, is the donor safe, has the product passed quality control, and how is the patient tolerating FMT?

01

Patient assessment

The physician reviews indications, contraindications, immune status, intestinal condition and the ability to tolerate nutrition.

02

Donor selection

Candidates undergo medical, laboratory, psychological and behavioural screening followed by regular re-testing.

03

Product control

Material is processed in a closed cycle, and each finished batch is checked for quality and safety.

04

Follow-up

Tolerance is assessed after administration and at follow-up points after the course to distinguish adaptation from a complication.

Donor safety

Jialan's three-level donor screening

The clinic describes a system combining laboratory tests, lifestyle assessment, continuous microbiota monitoring and donor-to-patient matching.

2.4%of candidates pass screening
251parameters are checked
8 weeksbetween complete re-screenings

Donor age: the 2022 Chinese consensus specifies adults aged 18–30, with children from age 3 permitted in paediatric practice. Jialan usually uses donors aged 3–30.

01

Basic medical screening

Medical history, examination, more than 40 blood and stool tests, and exclusion of infections, parasites and multidrug-resistant bacteria.

02

Psychology and lifestyle

Mental health, sleep, harmful habits, medication, travel, diet and other risk factors are assessed.

03

Continuous control and matching

Donors are fully re-tested every eight weeks, microbiota stability is monitored and donor selection uses the patient's data.

A candidate is excluded when screening identifies a risk

Infectious, gastrointestinal, autoimmune, metabolic, neurological or psychiatric disease
Antibiotics, acid-suppressing medicines, immunosuppressants or chemotherapy during the previous three months
Pathogens, parasites, fungi or multidrug-resistance genes found in testing
Smoking, alcohol, drug use, unsafe contact or travel with increased infection risk
Unstable results in mental health, anxiety, depression or sleep assessments
Inability to donate regularly or follow pre-donation restrictions

Material control

What is checked before the product is released

Safety depends on more than the donor's apparent health. Laboratory testing, microbiota stability, processing rules and batch traceability all matter.

Blood

Blood counts, liver and kidney function, electrolytes and C-reactive protein; tests for hepatitis, HIV, syphilis, Epstein–Barr virus and cytomegalovirus.

Stool

Occult blood, enteric pathogens, C. difficile, norovirus, rotavirus, SARS-CoV-2, parasites, fungi and drug-resistant bacteria.

Microbiota composition

Sequencing helps monitor composition stability, assess diversity and compare the donor microbiota with the patient's data.

History and lifestyle

Before donations, current health, medicines, travel and lifestyle changes are reviewed; donor health is monitored over time.

Five processing and traceability rules

Screening and quality control substantially reduce the risk of infection transmission, but they cannot make that risk zero.

1

Collection follows aseptic procedures.

2

Processing takes place in a closed anaerobic cycle and is completed within six hours of collection.

3

The material is filtered, centrifuged and purified under a laboratory protocol.

4

A finished product is used only after passing quality and safety checks.

5

Original samples are retained, and the donor–batch–patient chain must remain traceable.

Patient selection

When FMT is contraindicated

The 2022 Chinese expert consensus lists conditions in which procedural risk is unacceptable or another treatment path is required.

This list does not replace medical assessment. The physician decides after reviewing test results, diagnosis and the patient's current condition.

1Severe intestinal barrier damage with sepsis, bleeding or perforation
2Fulminant colitis or toxic megacolon
3Inability to tolerate enteral nutrition covering at least 50% of required calories
4Severe immunodeficiency
5Immunosuppressive therapy: prednisone 20 mg/day or more for longer than four weeks
6Neutropenia: below 1,500 cells/mm³ in adults or below 1,000 cells/mm³ in children
7Pregnancy and breastfeeding

Follow-up data

What is known about short- and long-term safety

Jialan's official FAQ cites a retrospective analysis by Huanlong Qin's group published in Lancet Gastroenterology & Hepatology in 2022.

8,547

patients with gastrointestinal symptoms

The analysis included patients who received FMT and assessed adverse events over short and long follow-up periods.

Follow-up period: from 2 weeks to 5 years

Overall short- and long-term safety was assessed as good.

Most short-term adverse events were mild or moderate and short-lived.

During long-term follow-up, rates of newly diagnosed gastrointestinal and respiratory disease did not differ from the general population.

Knowledge-base source: the official “A Thousand Questions, A Thousand Answers” FAQ, revised 17 July 2026.

These data do not mean complications are impossible: safety depends on correct selection, product quality and follow-up.

After transplantation

Temporary reaction or possible complication

The main clues are onset, duration and direction of change: a typical temporary reaction fades, while a complication persists or worsens.

Usually resolves on its own

Temporary adaptation reaction

When it begins

From a few hours to three days after transplantation

How long it lasts

One to seven days, most often one to three days

How it develops

Symptoms gradually become milder without signs of severe infection

  • Bloating and gas
  • Temporary stool changes
  • Aching abdominal pain or discomfort
  • Fatigue, headache or body aches
  • A slight rise in temperature

Medical assessment is needed

Signs of a possible complication

When it begins

Timing varies depending on the cause

How long it lasts

Does not improve, lasts longer than expected or returns

How it develops

The condition worsens or marked warning signs appear

  • High or persistent fever
  • Rash, itching or difficulty breathing
  • Increasing abdominal pain
  • Repeated vomiting or severe diarrhoea
  • Signs of dehydration or infection

Do not wait for routine follow-up

When to contact a doctor

The following symptoms need prompt medical assessment, especially if they worsen or occur together.

1

Temperature above 38.5°C

Especially if it persists or is accompanied by marked lethargy or chills.

2

Allergic reaction

Rash, intense itching, swelling or difficulty breathing require immediate help.

3

Repeated vomiting

The inability to drink and keep fluids down is a warning sign.

4

Frequent watery stools

Contact a physician if there is weakness, dry mouth, infrequent urination or other signs of dehydration.

5

No stool and no gas

A prolonged absence of both stool and gas may indicate intestinal obstruction.

6

Severe or increasing pain

Respiratory infection symptoms or a sudden general deterioration also require assessment.

If you are unsure, contact the treating team sooner: adaptation and a complication cannot be reliably distinguished through general advice alone.

Control after FMT

Follow-up continues after the course

The Chinese consensus and the clinic's official FAQ include several checkpoints for tolerance, symptoms and microbiota.

The Chinese consensus recommends at least eight weeks of follow-up after the final procedure, and longer where possible.

24 hours

1. After each administration

Tolerance is assessed and adverse reactions are recorded.

1 week and 1 month

2. Early follow-up

Symptom changes are reviewed and supportive care is adjusted if needed.

2 weeks after the course

3. Repeat analysis

The clinic's schedule includes repeat stool collection after all courses are complete.

3, 6 and 12 months

4. Long-term follow-up

The durability of changes and the need for further decisions are assessed.

Have a safety question about your case?

Tell the physician about the diagnosis, medicines, allergies and current symptoms. This matters more than a general answer without medical context.

View FAQ