Expanding research on the gut microbiome and its connections to other health areas is driving product development in the nutrition industry. ADM says advances in women’s health metabolites, the gut-brain axis, and strain-specific clinical research are helping companies develop more targeted, evidence-based solutions.
Nutrition Insight discusses microbiome breakthroughs and clinical research with Dr. Malwina Naghibi, head of Clinical Development in ADM’s R&D Medical Team. Some of the most significant breakthroughs have been expanding our understanding of how the microbiome interacts with the human body, new insights into mother-baby interactions, and a growing recognition of the role that microbial metabolites and postbiotics play in supporting health.
These advances are already beginning to influence clinical practice and product development with tangible impacts on people’s health and well-being. Naghibi points to the potential benefit of microbiome modulation prior to, or alongside, pharmacological treatments as an important area of progress.
Naghibi notes that research has expanded the understanding of the microbiome connection between mothers and babies. We know now that even if twins are born with the same genetic material, their microbiome footprint can be different within days of birth, influenced by factors such as order of birth and gestational age.
A publication in Nature Medicine significantly advanced our understanding of how environmental mechanisms shape a baby’s microbiome in their early days and into childhood. In this study, researchers mapped the gut microbiome evolution in twins, from birth until they were eight years old.
Naghibi adds that there is now evidence to guide us deeper into understanding the role of how a Lactobacillus-dominated vaginal microbiome can influence healthy pregnancies. In contrast to the gut microbiome, lower microbial diversity (with a dominance of Lactobacillus species) is generally associated with vaginal health.
Researchers are increasingly focused on microbial metabolites, the bioactive compounds produced by the microbiome, which are now recognized as key drivers of microbiome function.
This shift has also accelerated interest in postbiotics, where inactivated microorganisms may deliver health benefits with advantages in stability, formulation, and manufacturing compared with live microbes. ADM is investing significantly in preclinical and clinical research in postbiotics, across a range of physiologies.
Two ADM trials have helped reshape our understanding of postbiotics. In an irritable bowel syndrome clinical trial published in 2024, a probiotic and a postbiotic of the same Bifidobacterium longum CECT7347 strain generated comparable results, offering significant improvement in symptom scores and quality of life.
Naghibi points to the gut-brain axis and psychobiotics as some of the most exciting areas of innovation. Research has found that even if twins are born with the same genetic material, their microbiome footprint can be different within days of birth.
ADM’s preclinical and clinical pipeline aims to achieve tangible effects for individual consumers. The company has set up R&D centers in Valencia (Spain), Kennesaw (US), Cork (Ireland), and Wuxi (China). Naghibi notes these work on multiple biotics and numerous preclinical evaluations at any given time to inform decisions on the best candidate biotics to take forward to human clinical trials.
One of the field’s most important learnings is that efficacy cannot be generalized across a bacterial genus or species. Rather, effects are strain-specific. Clinical evidence needs to be generated for individual strains or well-characterized strain combinations, making rigorous preclinical work essential.
ADM begins by thoroughly characterizing candidate strains, including full genome sequencing and safety assessments, before evaluating their stability and biological activity in a range of preclinical models. If data are promising, they then advance to human clinical trials.
Naghibi explains that ADM’s R&D Medical Team helps translate those results into relevant, scientifically rigorous clinical trials. The company believes the industry should hold itself to the highest standards of clinical evidence, which includes well-designed, randomized, controlled clinical trials following the standards of Good Clinical Practice (GCP).
All clinical trials currently in ADM’s pipeline are randomized, double-blind, placebo-controlled trials run to GCP standards and prospectively registered in public clinical research domains for full transparency. This scientifically rigorous approach generates credibility with scientists and clinicians, which in turn translates to trust by consumers.
Generating robust clinical evidence is essential, but Naghibi notes that building consumer trust also depends on regulatory frameworks that evolve alongside scientific progress. Across many markets, regulatory requirements for food supplements have become increasingly rigorous over the past decade.
This plays a key role in protecting consumers. In parallel, there is also a need for regulatory frameworks to enable a pathway for clinical research — especially research meeting gold standards — to be shared more broadly. It can be challenging for regulations to match the pace at which the research is advancing, exemplifying the microbiome as an exponentially growing body of scientific evidence.
Naghibi concludes that it’s essential for leaders in the microbiome research space to engage in an active dialogue with regulators so that they can learn from each other and ensure that consumers have access to the most accurate information about the latest science, allowing them to make informed decisions about their health and well-being.
They must work together to address the challenges of hospital claim denials and other issues affecting the healthcare industry.
Furthermore, the industry needs to focus on managing healthcare data effectively to ensure that research and development are based on accurate and reliable information.
