The National Institute of Standards and Technology (NIST) just released a human stool reference material to support gut microbiome research. It’s a practical tool for a field that’s tackling some of the toughest, hard‑to‑treat diseases.
Inside our gut lives a vast community of microbes and their byproducts, stretching along the digestive tract. Over the past decade, researchers have linked this ecosystem to everything from obesity and diabetes to mood disorders and certain cancers. Now, drugs aimed at rebalancing the microbiome may offer new treatment avenues.
So what’s the difference between microbiota and microbiome? Microbiota names the bacteria, viruses, fungi and other organisms living in the gut. The microbiome goes further, covering their genes and the chemicals they produce. That extra layer of detail is key: it’s those biochemical exchanges that connect the microbiome to vital functions well beyond simple digestion.
With eight frozen vials and more than 25 pages of data on microbes and biomolecules, NIST’s reference material gives labs a common yardstick. It’s a step toward more reliable, comparable results—and, ultimately, better therapies.
The NIST reference material, called Human Fecal Material RM, includes eight frozen vials of human feces in aqueous solution, accompanied by over 25 pages of data describing the microorganisms and biomolecules present. It will also be a useful tool for those working in biopharmaceutical and biotechnology companies engaged in the development of new microbiome-based drugs, including those containing live bacteria.
Scott Jackson, molecular geneticist at NIST, explained: “It is the most precisely measured and analyzed human fecal standard ever produced. We hope our material lays the foundation for solid growth in gut microbiome research.”
New frontiers in medicine
Although it may seem unappealing, feces-based therapies represent one of the most promising areas of medical research. In the United States, the FDA has approved two feces-derived drugs to treat recurrent infection from Clostridioides difficile, a bacterium associated with around 30,000 deaths per year.
Fecal transplants—transferring feces from a donor to a patient—have shown 95% effectiveness against this infection. This success has driven researchers to study the use of fecal transplants also against alcoholic hepatitis, colitis, certain types of cancer, and other diseases linked to the gut microbiome.
These treatments work by modifying the composition and behavior of the microbiome. Unlike common over-the-counter probiotics, the new drugs will be scientifically tested to demonstrate clinical effectiveness against specific diseases. The NIST reference material will help achieve this goal.
Jackson commented: “We are at the beginning of a new era of live microbial therapies. And it is already happening.”
Why a reference material is needed
Microbiome research is fast and competitive. Every year discoveries and investments multiply to develop new drugs. However, the methods used in laboratories to analyze the microbiome vary greatly, leading to results that are hard to compare.
Jackson explained: “If two laboratories analyze the same fecal sample, they may obtain very different results.”
This variability hinders reproducibility, a basic principle of science. The NIST material will help standardize researchers’ work, improving accuracy, consistency, comparability, and reproducibility of studies.
How it will be used
NIST produces over 1,000 reference materials for life sciences, such as cholesterol, human DNA, and blood serum. They are key tools to ensure precision and quality in clinical tests.
Among the planned uses for the fecal material:
- Compare different methods: it will serve as a “benchmark” to evaluate analysis techniques and choose the ones best suited to research goals.
- Verify reproducibility: if two laboratories obtain similar results using the NIST material, it means their methods are reliable.
How it was created
To obtain the fecal material, NIST collaborated with a medical company that collected samples from healthy adult men and women. Half of the donors were vegetarians, half omnivores, to represent greater variability.
Analyzing the samples was complex. Feces contain trillions of microorganisms from hundreds of different species, food particles, human cells, and numerous enzymes, proteins, and metabolites. It is one of the most complex known biological materials.
More than twelve scientists worked for six years to develop the reference material. They managed to identify over 150 metabolites and more than 150 microbial species. The material was made stable (with an expected shelf life of at least five years) and homogeneous (each sample is identical within specified uncertainty margins).
Jackson stated: “With a lot of teamwork and collaboration with the scientific community, we managed to create a material that meets the needs of those working in the field.”
Glossary
- FDA: Food and Drug Administration, U.S. government agency that regulates drugs and food.
- Gut microbiome: The set of microorganisms present in the human intestine.
- NIST: National Institute of Standards and Technology, a U.S. Department of Commerce agency.
- RM: Reference Material.
- Fecal transplant: A medical procedure involving the transfer of feces from a healthy donor to a patient.
