Live Biotherapeutic Products and Fecal Microbiota Transplant: How They Differ From Supplements
How live biotherapeutic products and fecal microbiota transplant differ from probiotic supplements, what the FDA says about them, and why they are clinician-led treatments.
Content last updated . This page has not been medically reviewed.
Urgent first
Repeated, severe or watery diarrhea after antibiotics, with fever, belly pain, dehydration or dizziness, needs prompt medical care. Recurrent Clostridioides difficile (C. diff) infection is serious: FDA documents list complications of recurrence that include dehydration, hypotension and kidney failure. [1] Do not treat suspected C. diff with a supplement or a home-made stool preparation. In the US, call 911 for an emergency.The short answer
A probiotic supplement, a live biotherapeutic product and a fecal microbiota transplant all involve living microbes, but they are treated very differently. Supplements are sold with limited pre-market checking. Medicines made from live microbes are developed through clinical trials and regulator review, and fecal transplant is a clinician-led procedure. This page is information only and explains the differences. It is not a treatment guide.The differences at a glance
| Term | What the sources we read say | Source |
|---|---|---|
| Probiotic supplement | In the US it may be regulated as a dietary supplement, a food ingredient or a drug, depending on intended use. Many are supplements that do not need FDA approval before marketing. | NCCIH [2] |
| Live biotherapeutic product (LBP) | In FDA guidance: a biological product that contains live organisms such as bacteria, is applicable to preventing, treating or curing a disease or condition, and is not a vaccine. | FDA, guidance issued 2012, updated June 2016 [3] |
| Fecal microbiota transplant (FMT) | The FDA describes fecal microbiota collected from healthy individuals as being investigated for treating C. difficile infection, and says FMT used for that purpose meets the definition of a biological product. | FDA, November 2022 [4] |
| Licensed fecal microbiota products | The FDA lists products by their proper names, for example "fecal microbiota, live-jslm" and "fecal microbiota spores, live-brpk", for preventing recurrence of C. difficile infection in adults. | FDA documents, 2022 and 2023 [1][5] |
The FDA's LBP guidance gives an example: one or more strains of lactobacilli given orally to treat patients with ulcerative colitis. [3] It says the guidance covers LBPs that are lawfully marketed as foods, such as dietary supplements, when they are proposed for clinical uses regulated as biologics. [3] In plain terms, the same kind of organism can be a supplement on a shelf or a drug under study. What changes is the claim and the evidence behind it. See How probiotics are regulated.
What the FDA says about FMT
- Status: the FDA says FMT used for C. difficile infection is a biological product. [4]
- Enforcement discretion: in a November 2022 guidance, the FDA said it intends to use enforcement discretion on investigational new drug (IND) requirements, under limited circumstances, for FMT used to treat C. difficile infection not responding to standard therapies. [4]
- Conditions: the treating licensed health care provider obtains consent that says the use is investigational and discusses foreseeable risks, and the donor and stool are screened and tested under the provider's direction. [4]
- Stool banks: the policy does not apply to FMT obtained from a stool bank. The FDA cited safety concerns about centralized manufacturing, including transmission of infectious agents. [4]
- Other uses: the policy does not extend to other uses of FMT. [4]
- A safety alert: the guidance notes a March 2020 FDA safety alert after patients developed infections caused by enteropathogenic Escherichia coli (two patients) and Shiga toxin-producing E. coli (four patients) following an FMT product from a stool bank. [4]
The FDA policy is built around a licensed provider, consent, and donor and stool screening and testing. [4] It does not describe home preparation, and we do not recommend it.
Research in earlier stages
In a 2018 study of people after antibiotics, returning the person's own stool microbiome (autologous FMT) was followed by rapid and near-complete recovery within days, while a multi-strain probiotic was linked with delayed and incomplete recovery. [6] That is early research on recovery of the gut microbiome, not a treatment available to the public, and it does not show better health outcomes.Frequently asked questions
Is a live biotherapeutic product the same as a probiotic?
Not necessarily. The FDA defines an LBP as a biological product with live organisms, applicable to preventing, treating or curing a disease, and not a vaccine. [3] A probiotic supplement is generally sold as a dietary supplement or food. [2]
Is fecal microbiota transplant a supplement?
No. The FDA says FMT used for C. difficile infection is a biological product. [4]
Can I make my own FMT at home?
We do not recommend it. The FDA policy we read is built around a licensed provider, consent, and screening and testing of donor and stool; it does not describe home preparation. [4]
What about probiotic supplements and C. difficile?
The evidence is covered on the C. difficile page linked above. Treatment is clinician-led, and the FDA document cites guidelines recommending antibiotic regimens for a first recurrence. [1]
Has the FDA approved a probiotic for infants?
The FDA said in 2023 that it has not approved any probiotic product as a drug or biological product for infants of any age, and warned of risks for preterm infants. [7]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Licensed products for recurrent C. difficile
What we did not find
Safety and who should ask a clinician
References
- US Food and Drug Administration. Summary Basis for Regulatory Action, fecal microbiota, live-jslm. 30 November 2022. First pages read 2026-10-23.
- NCCIH (US National Center for Complementary and Integrative Health). Probiotics: Usefulness and Safety. Page last updated August 2019 as shown on the page. Read 2026-10-23.
- US Food and Drug Administration. Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information. Guidance for industry, February 2012, updated June 2016. Full guidance PDF read 2026-10-23.
- US Food and Drug Administration. Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies. Guidance for industry, November 2022. Full guidance PDF read 2026-10-23.
- US Food and Drug Administration. Biologics product page for fecal microbiota spores, live-brpk. Content current as of 18 May 2023. Read 2026-10-23.
- Suez J, et al. Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT. Cell. 2018;174(6):1406-1423. Abstract read 2026-10-23.
- US Food and Drug Administration. FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants. News release, 2023. Read 2026-10-23.