Discover the difference between Vitamins & Probiotics. And why clinical trials for probiotics are needed.
What are Vitamins?
When consumed within recommended doses, vitamins are generally considered safe for consumption. These essential nutrients are vital for the proper functioning of our bodies, and deficiencies in specific vitamins can result in a range of health issues. Due to their longstanding use and natural presence in numerous foods, vitamins have not undergone the extensive clinical trials that new drugs or treatments typically experience.
What are probiotics?
Probiotics are living bacteria that provide health benefits to the hosts, especially the digestive system. When talking about bacteria, people often think of them as disease-causing agents. However, the human body is fully filled with both valuable (probiotics) and harmful bacteria. Probiotics are commonly called “good” or “beneficial” bacteria because they help maintain a healthy gut when used in appropriate doses. Using probiotics for the prevention or supportive treatment of digestive disorders is a natural approach and perhaps the most common application of probiotics, as most of their health benefits are directly or indirectly related to the digestive system.
Mechanism of action of probiotics
Scientific researchers have been trying to uncover the mechanism of action of probiotics, which can help promote a healthy body:
- Under an imbalanced beneficial bacteria condition in the body, such as after the use of antibiotics, probiotics can replace the lost native beneficial bacteria or even create a favorable environment to increase the numbers and diversity of native beneficial bacteria and reduce the variety of harmful bacteria.
- Probiotics can re-balance the gut microflora between beneficial and harmful bacteria to keep the body functioning normally.
- Probiotics can secrete antimicrobial substances to inhibit or kill harmful bacteria, preventing infections.
- Probiotics play a crucial role in the maturation of the digestive system due to the ability to actively participate in the production of mucus and the activity of enzymes in the gastrointestinal mucosa.
Do Probiotics Need Clinical Trials?
Why are Clinical Trials necessary?
Data analysis of clinical trials from 2010 to 2017 has shown four possible reasons attributed to the 90% clinical failures of drug development, was mainly due to lack of clinical efficacy (40%–50%), unmanageable toxicity (30%), poor drug-like properties (10%–15%), and lack of commercial needs and poor strategic planning (10%) . As a result, clinical trials play an essential role in developing or testing new drugs, devices, treatments, and procedures to evaluate safety and effectiveness before widespread use. Specifically, a clinical trial is a type of study with human participants (“research volunteers” or “research subjects”) to find the answer to a scientific problem.
Why don’t vitamins need clinical trials?
The US Food and Drug Administration (FDA) has specific requirements for new drugs but usually does not require clinical trials for dietary supplements such as vitamins. Because vitamins are in the group of micronutrients, they are organic compounds that the body cannot synthesize, and most of them must be obtained from the outside through daily foods. Taking vitamins in recommended doses is safe because foods also contain vitamins necessary for normal body functions; conducting extensive clinical trials to assess their safety may not be required. In addition, short clinical trials may not last long enough to identify vitamins that significantly affect some of the diseases being studied.
Moreover, over a longer period, adherence to the test nutrient often decreases, reducing the contrast with the control group and increasing the likelihood that the results won’t differ between nutrient users and non-users. It’s important to note that while vitamins may not undergo extensive clinical trials, they are still subject to regulatory quality control and manufacturing practices to ensure consumer safety and efficacy.
A Different Story with Probiotics
In contrast to vitamins, probiotics are defined as “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host.” More than 1.800 clinical studies with probiotics, registered at ClinicalTrials.gov and/or the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization, have addressed over 700 different diseases and conditions [1,2,3]. Natural probiotics generally consist of live microorganisms that may carry potential risks, particularly for vulnerable populations or when specific strains are employed. Hence, researchers conduct clinical trials for probiotics to assess safety, determine optimal dosages, and explore potential interactions with other medications.
In recent years, researchers have focused on characterizing the human intestinal microbiome and determining the role of individual species. When ingested or applied to the skin, probiotics interact with the body’s resident microflora to balance pathogens and beneficial bacteria. For this reason, probiotics help restore the balance of the microflora after antibiotic treatment.
Currently, the commonly used probiotics belong to the genera Lactococcus, Streptococcus and Enterococcus, Bacillus sp., Enterococcus faecium SF68, and some yeast strains of the genus Saccharomyces. In addition, there are reports of the unique role of probiotics in the prevention and supportive treatment of obesity, diabetes, allergies, asthma, lung diseases, autoimmune diseases, HIV (Human Immunodeficiency Virus) infections, cancers, urogenital infections, gastrointestinal disorders such as diarrhea, irritable bowel syndrome, necrotizing enterocolitis, or cirrhosis, as well as in the eradication of Helicobacter pylori infections [1,4]. Likewise, probiotics are increasingly explored for application in atopic diseases and skin health and vaginal preparations against bacterial vaginosis and associated infection problems .
Most clinical trials for probiotics studies at ClinicalTrials.gov are registered in the USA or Europe (56%). The data from ICTRP represents the rapid expansion of clinical studies with probiotics in Asia, notably Iran and China . Developing probiotics to ensure safety and effectiveness in clinical treatment is very important. With this in mind, LiveSpo Pharma, the leading enterprise in the probiotic spores field in Vietnam, pays attention to clinical trials for probiotics at leading prestigious medical agencies and meets standard requirements.
5 Reasons LiveSpo Does Clinical Trials for Probiotics
- Safety Evaluation: Clinical trials allow for the rigorous assessment of a product’s safety profile. They help identify and monitor potential adverse effects, ensuring the product’s benefits outweigh the risks. Collecting data from diverse participants helps provide insights into how a product may interact and uncover safety concerns.
- Efficacy Assessment: Clinical trials for probiotics help determine whether a product effectively achieves its intended outcomes. They provide scientific evidence by comparing the product’s effectiveness against a control group or existing standard of care. This ensures that products work and deliver the expected benefits.
- Optimal Dosage and Treatment Regimens: Clinical trials help establish a product’s appropriate dosage, treatment duration, and administration guidelines. This information is crucial for healthcare professionals to accurately prescribe and administer the product, ensuring optimal therapeutic results.
- Regulatory Compliance: Clinical trials are a regulatory requirement in many countries to ensure that products meet the necessary safety, efficacy, and quality standards before being approved for public use. Regulatory agencies use the data from clinical trials to evaluate the product’s benefits and risks, granting authorization or approval based on the available evidence.
- Continuous Improvement and Innovation: Clinical probiotic trials contribute to scientific knowledge and pave the way for advancements in medical treatments and interventions. Ongoing clinical trials refine products, uncover new indications, and enhance the overall understanding of diseases and patient care.
Overall, Clinical Trials are essential to ensure that products are safe, effective, and beneficial for patients. They provide a rigorous scientific framework for evaluating new interventions and help guide healthcare decision-making based on reliable evidence.
- Dronkers, T. M., Ouwehand, A. C., & Rijkers, G. T. (2020). Global analysis of clinical trials with probiotics. Heliyon. 6(7).
- Dudek-Wicher, R., Junka, A., Paleczny, J., & Bartoszewicz, M. (2020). Clinical trials of probiotic strains in selected disease entities. International Journal of Microbiology.
- Food and Agriculture Organization (FAO) London, UK: FAO; (2002). Guidelines for the evaluation of probiotics in food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for Evaluating Probiotics in Food.
- Hill, C., Guarner, F., Reid, G., Gibson, G. R., Merenstein, D. J., Pot, B., & Sanders, M. E. (2014). Expert consensus document: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nature reviews Gastroenterology & hepatology. 11(8):506–514.
- Martinez RCR, Franceschini SA, Patta MC, et al. (2009) Improved cure of bacterial vaginosis with a single dose of tinidazole (2g), Lactobacillus rhamnosus GR-1, and Lactobacillus reuteri RC-14: a randomized, double-blind, placebo-controlled trial. Can J Microbiol.55(2):133–8
- Sun, D., Gao, W., Hu, H., & Zhou, S. (2022). Why does 90% of clinical drug development fail, and how to improve it? Acta Pharmaceutica Sinica B, 12(7), 3049-3062.