Akkermansia, Faecalibacterium and "Next-Generation" Probiotics: Early Research and Claims
What "next-generation probiotics" such as Akkermansia and Faecalibacterium are, what human trials and EFSA safety opinions say so far, and where claims run ahead of evidence.
Content last updated . This page has not been medically reviewed.
What is Akkermansia, Faecalibacterium and next-generation probiotics good for?
What the body uses it for, and how strong the evidence is. A normal job in the body is not proof that extra supplements add benefit; each card says which.
Gut-resident organisms
Not enough evidenceAkkermansia muciniphila and Faecalibacterium are normal members of the gut community. Being common in healthy guts does not show that taking them as a supplement helps.
Supplements: No proven supplement benefit; human research on these organisms is still lacking.
Insulin sensitivity (Akkermansia, pasteurised)
Preliminary or mixedIn a 2019 pilot of 32 overweight adults, pasteurised A. muciniphila improved insulin sensitivity versus placebo. A larger 2026 trial of one strain (MucT) missed its main insulin-sensitivity endpoint.
Supplements: Mixed. Results apply only to the tested strains, the pasteurised form and those groups.
Cholesterol (Akkermansia, pasteurised)
Preliminary or mixedTotal cholesterol fell about 8.7% against placebo in the 2019 pilot. This was not confirmed in a second source we read.
Supplements: Preliminary; small exploratory study.
Subgroup responses
Preliminary or mixedIn the 2026 trial, people with low baseline Akkermansia, prediabetes or age 63 and over improved on exploratory measures. Exploratory subgroup results are ideas to test, not proof.
Supplements: Hypothesis only.
Short-chain fatty acid production and gut barrier
Lab or animal research onlyReviews say these organisms make short-chain fatty acids and may help keep the gut lining intact. This comes mostly from lab and animal work.
Supplements: Not shown in people.
Lower Faecalibacterium in disease
Lab or animal research onlyFaecalibacterium levels are lower in inflammatory bowel disease and several other conditions. This is an association and does not show that giving the organism treats anything.
Supplements: No supplement trial read.
Regulatory status
Not enough evidenceThese organisms often fall under live biotherapeutic products, a class made for pharmaceutical use. Regulatory approval is rare.
Supplements: Not applicable.
Connected topics
Open a group to see how each topic connects and how strong the evidence is.
Health goals (3)
- Blood Sugar BalancePreliminary or mixed
Insulin sensitivity improved in a small 2019 pilot but not in the main result of a 2026 trial; only exploratory subgroups (prediabetes, older age, low baseline Akkermansia) improved. Not enough to claim blood-sugar support.
- Cholesterol BalancePreliminary or mixed
Total cholesterol fell about 8.7% with pasteurised A. muciniphila versus placebo in a 2019 pilot of 32 completers. This was not re-confirmed in sources we read.
- Metabolic HealthPreliminary or mixed
A 2019 pilot (40 adults, pasteurised A. muciniphila) improved insulin sensitivity and cholesterol versus placebo; a larger 2026 trial (142 adults, strain MucT) missed its main insulin-sensitivity endpoint. Results apply to those strains and groups only.
Body systems (4)
- Digestive SystemLab or animal research only
These organisms live in the gut and are being studied as possible future gut-targeted biotherapeutics. Human evidence for supplements is limited.
- Gut HealthLab or animal research only
These organisms live in the gut and are being studied as possible future gut-targeted biotherapeutics. Human evidence for supplements is limited.
- Blood Sugar SupportPreliminary or mixed
Insulin sensitivity improved in a 2019 pilot but not in the 2026 trial main result.
- Metabolism & WeightPreliminary or mixed
Two human trials of pasteurised A. muciniphila gave mixed metabolic results (positive pilot, missed main endpoint in the larger trial).
Body parts (1)
- GutLab or animal research only
The organisms are gut residents; reviews describe effects on the gut barrier and short-chain fatty acids mostly from lab and association work.
Biomarkers (1)
- InsulinPreliminary or mixed
Fasting insulin fell about 34% with pasteurised A. muciniphila in a 2019 pilot; the 2026 trial primary insulin-sensitivity result did not differ from placebo.
Documented risks and interactions (1)
- Safety limits (EFSA, pasteurised Akkermansia). EFSA judged pasteurised A. muciniphila safe at set daily cell counts for adults and adolescents. For pregnant and breastfeeding women safety has not been established.
Evidence labels used below: promising but limited, mixed, insufficient evidence, preclinical, marketing claim. They are our plain summaries.
Akkermansia muciniphila: what humans were given
| Study | Who and how long | What was found | Label |
|---|---|---|---|
| Depommier et al., 2019 | 40 overweight or obese adults with insulin resistance (32 finished); 10^10 bacteria daily, live or pasteurized, 3 months | Safe and well tolerated. Against placebo, pasteurized bacteria improved insulin sensitivity (+28.62%) and lowered total cholesterol (-8.68%); weight change was small (P = 0.091). The authors called it proof-of-concept. [4] | Promising but limited |
| Suenaert et al., 2026 | 142 adults with metabolic syndrome; 30 billion pasteurized cells daily, 4 months | The main endpoint (whole-body insulin sensitivity) did not differ from placebo. Exploratory subgroup results (for example people with low baseline Akkermansia) were more favorable. [5] | Mixed |
These two trials used particular strains and a pasteurized (heat-treated) form. Do not carry them to other Akkermansia products, to live cells, or to people without these conditions. Weight-loss and blood-sugar claims are reviewed on probiotics, weight and metabolic health.
Faecalibacterium and others
A 2023 review describes Faecalibacterium as a genus whose levels are lower in several diseases, and argues the data support developing it as an NGP or live biotherapeutic. [8] That is a research argument built largely on association (lower amounts in sick people), which does not show that giving the organism treats anything; see association versus causation. Proper evidence not found for a randomized trial of a Faecalibacterium supplement in people (searched: PubMed for Faecalibacterium prausnitzii supplementation trials and live supplement safety; the one hit tested a nutraceutical blend that raised F. prausnitzii levels, which is a biomarker change and a different product). [9] Other candidates named in the 2024 review, such as Eubacterium hallii, Roseburia and Bacteroides fragilis, are early-stage; it notes that oxygen-sensitive organisms are hard to culture and store. [3]Claim check
- "Boosts your Akkermansia" or "microbiome-matched" products: a trial subgroup finding is a hypothesis, not proof. See personalized probiotic claims.
- "Next-gen" does not mean tested for safety. The ISAPP paper (2023) says species without a history of safe use must be assessed case by case. [10]
Frequently asked questions
What is a next-generation probiotic?
It is an informal term for gut organisms beyond the usual probiotics, overlapping with live biotherapeutic products meant for pharmaceutical use. [1]
Does Akkermansia help with weight or blood sugar?
A 2019 pilot found improvements with pasteurized cells in overweight adults; a larger 2026 trial missed its main endpoint. [4][5]
Is Akkermansia safe in pregnancy?
EFSA's 2025 opinion says safety in pregnant and lactating women has not been established. [7]
Can I buy Faecalibacterium as a supplement and expect results?
We found no randomized trial of such a supplement; low levels in sick people are an association only. [8]
Are these organisms regulated like drugs?
A 2017 perspective says NGPs are likely better suited to a pharmaceutical route, and a 2024 review says regulatory approval is rare. [1][3]
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.
What EFSA said (EU safety opinions)
- 2021: EFSA's panel judged pasteurised A. muciniphila safe at 3.4 x 10^10 cells a day for the target population (adults, excluding pregnant and lactating women), provided viable cells were below the detection limit. [6]
- 2025: for adolescents 12 to under 18 it set limits of 2.1 x 10^10 (ages 12 to under 14) and 3.0 x 10^10 cells a day (14 to under 18). It said safety in pregnant and lactating women has not been established. [7]
These are safety opinions about one pasteurised novel food in the EU, not statements that it works. Whether or where products are authorized or sold was not in the sources we read, and US status is not described in them.
Safety and who should ask first
References
- Next-generation probiotics: the spectrum from probiotics to live biotherapeutics (O'Toole PW, Marchesi JR, Hill C. Nat Microbiol 2017). PMID 28440276. Read 2026-10-22.
- World Gastroenterology Organisation. WGO Global Guideline: Probiotics and prebiotics. February 2023. Read 2026-10-22.
- Next-generation probiotics: the upcoming biotherapeutics (Al-Fakhrany OM, Elekhnawy E. Mol Biol Rep 2024). PMID 38619680. Read 2026-10-22.
- Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study (Depommier C et al. Nat Med 2019). PMID 31263284. Read 2026-10-22.
- Effect of pasteurized Akkermansia muciniphila MucT on insulin sensitivity, body composition, and GLP-1 production in subjects with metabolic syndrome (Suenaert P et al. Gut Microbes 2026). PMID 42343233. Read 2026-10-22.
- Safety of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283 (EFSA Panel on Nutrition, Novel Foods and Food Allergens. EFSA J 2021). PMID 34484452. Read 2026-10-22.
- Safety of an extension of use of pasteurised Akkermansia muciniphila as a novel food pursuant to Regulation (EU) 2015/2283 (EFSA Panel on Nutrition, Novel Foods and Food Allergens. EFSA J 2025). PMID 41018002. Read 2026-10-22.
- Faecalibacterium: a bacterial genus with promising human health applications (Martín R et al. FEMS Microbiol Rev 2023). PMID 37451743. Read 2026-10-22.
- Nutraceutical Blends Promote Weight Loss, Inflammation Reduction, and Better Sleep: The Role of Faecalibacterium prausnitzii in Overweight Adults (Santamarina AB et al. Mol Nutr Food Res 2025). PMID 39981988. Read 2026-10-22.
- Emerging issues in probiotic safety: 2023 perspectives (Merenstein D et al. Gut Microbes 2023). PMID 36919522. Read 2026-10-22.
- NCCIH (US National Center for Complementary and Integrative Health). Probiotics: Usefulness and Safety. Read 2026-10-22.