Probiotic Clinical Trial Services for Probiotic and Postbiotic Supplements

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Postbiotics are preparations of inanimate microorganisms and/or their components that confer a health benefit on the host (Hill et al., 2014; Salminen et al., 2021). A probiotic and postbiotic clinical trial measures outcomes in volunteers who take the actual product, to find out whether the formula has the intended effect on gastrointestinal health and whether consumers tolerate it well.

The market for probiotic and postbiotic dietary supplements continues to grow in Thailand and worldwide, and consumers are paying more attention to gastrointestinal health. Brand owners who want to state on a label or in marketing materials that a product “supports gastrointestinal health” or “helps balance the gut microbiota” need scientific evidence to support that statement, and food advertising must comply with the Food Act B.E. 2522 (1979), including advertising approval where the law requires it.

Because probiotic efficacy is strain-specific, each study has to be designed for the specific product formula. VISBIO Co., Ltd. provides study design, project management and project coordination for clinical studies of probiotic and postbiotic dietary supplements, in collaboration with a network of partner clinical research sites and hospitals. The service covers both gastrointestinal health outcomes and tolerability assessment under Good Clinical Practice (GCP), from protocol planning to the final report, for sponsors in Thailand and abroad.

Under the Food Act B.E. 2522 (1979), the Thai Food and Drug Administration (Thai FDA) authorizes dietary supplements mainly on the basis of product safety and quality; authorization does not confirm clinical efficacy. The food registration number (Thai FDA number) on the label is therefore not evidence that a probiotic or postbiotic product on the market has the effect on gastrointestinal health shown on its label.

This distinction matters to brand owners, because consumers, modern trade channels and export partners increasingly ask for evidence that can be verified. The gap between “having a Thai FDA number” and “having evidence of efficacy” is therefore an important issue, especially for probiotics, which are complex in their own way: efficacy is strain-specific, and the size of the effect depends on the dose received and on the claim to be demonstrated.

A clinical trial is designed to answer this question directly, by measuring outcomes in volunteers who take the actual probiotic or postbiotic product, using symptom assessment tools that are accepted in international clinical research. The data support product development and evidence-based communication.

Hill et al. (2014) set out the definition of probiotics agreed by the International Scientific Association for Probiotics and Prebiotics (ISAPP): “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.” This definition stresses two elements that product developers must always consider, the viability of the microorganisms and an adequate amount, and both factors directly affect how a clinical trial is designed.

Salminen et al. (2021) defined postbiotics, a category that has been attracting attention quickly, as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” The defining feature of a postbiotic is that the microorganisms have been inactivated, so postbiotics are more stable during storage than typical probiotics.

The main challenge in developing supplements in this category is the strain-specific effect. Results demonstrated for one strain cannot be cited for another strain, and gastrointestinal health outcomes must be measured with standard assessment tools designed specifically for clinical research, so that the data carry scientific weight and are accepted internationally.

Every study follows GCP and takes into account the particular characteristics of probiotic and postbiotic products, including strain specificity and tolerability. VISBIO designs the study and manages it from planning to delivery of the report, while volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Step 1: Consultation and protocol design

Together with the investigators of a partner research site, VISBIO reviews the product’s characteristics, the outcomes the sponsor wants to claim and the purpose of the product, in order to define a suitable study plan, including the choice of a primary endpoint for gastrointestinal health or tolerability. This step covers setting inclusion and exclusion criteria that fit the claim, and estimating a sample size with adequate statistical power.

Step 2: Approval from the human research ethics committee

Before any data are collected, the protocol and the informed consent documents must in every case be approved by a human research ethics committee (Institutional Review Board: IRB). VISBIO coordinates document preparation with the site’s investigators and follows up on revisions requested by the committee until approval is granted.

Step 3: Volunteer recruitment and screening

Once approval is granted, the research site responsible for the study recruits and screens volunteers according to the protocol. The site’s physicians and investigators make sure that every volunteer receives complete information, gives written consent and passes a health screening before joining the study. VISBIO coordinates schedules and study readiness between the sponsor and the research site.

Step 4: Study conduct and data collection

Volunteers receive the product, and data are collected at the time points set in the protocol, using standard assessment tools accepted in international clinical research, such as the Gastrointestinal Symptom Rating Scale (GSRS) (Svedlund et al., 1988), the Bristol Stool Form Scale (BSFS) (Lewis & Heaton, 1997) and a tolerability diary, together with recording of adverse events throughout the study. The site’s investigators assess the volunteers and look after their safety, while VISBIO, as project manager, monitors progress and the completeness of the data.

Step 5: Data analysis and reporting

All data are analyzed statistically according to a statistical analysis plan (SAP) set in advance and summarized in a complete scientific report in an internationally used format. VISBIO coordinates the analysis and delivers the report to the sponsor. The report supports product development and evidence-based communication.

This service is designed for dietary supplements in various formats that aim to communicate about gastrointestinal health or tolerability. Examples of suitable ingredient types are shown below.

Evidence from a clinical study is not just a regulatory document. It is a strategic asset that owners of probiotic and postbiotic brands can use to create value in several ways.

Premium product positioning

A product with clinical study data can be positioned in the premium segment on a reasoned and credible basis. In a crowded market where differences between products are hard to communicate, outcomes actually measured in the group that received the product, compared with a control group, give the product’s positioning a data-based foundation.

Negotiations with modern trade and e-commerce channels

Many e-commerce platforms and modern trade buyers ask for supporting scientific documents for health products in the probiotic category. A clinical study report prepared under GCP is a key document that makes negotiations and product listing in these channels smoother, and gives an advantage over competitors without such data.

Lower legal risk and expansion into export markets

Statements about gastrointestinal health that are supported by clinical study evidence reduce the risk that advertising will be considered exaggerated under the Food Act B.E. 2522 (1979). In addition, many export markets, such as the European Union, Japan and ASEAN, require claim substantiation before a product goes on sale. A study designed and reported to international practice is therefore an important part of preparing to enter these markets, although each country has its own requirements.

Using scientific data in marketing communication

Data actually measured in a clinical study can be used across several communication channels, including digital media, product labels and point-of-sale materials. Advertising use, however, requires proper advertising approval from the Thai FDA before publication, as required by law.

1. Dietary supplements sold in Thailand must already have a food registration number (Thai FDA number) before the study starts. For products of sponsors from abroad, VISBIO assesses the legal conditions together with the research site on a project-by-project basis.
2. VISBIO and the research site design the study plan specifically for each product and its claim.
3. Every study must be approved by a human research ethics committee before it starts, without exception.

For brands that want evidence at every level, VISBIO supports work from initial activity testing at the cellular level (In Vitro) and ex vivo models through to clinical studies in volunteers. GCP applies to studies in humans, while cell-based and ex vivo work is carried out in the laboratory according to the test method for each assay. Planning every level of evidence with a single coordinator keeps the data from each stage consistent and leaves no gaps. For clinical studies of other types of dietary supplements, see the clinical efficacy evaluation service for knee health supplements.

What is the difference between probiotics and postbiotics?

Probiotics are live microorganisms that confer a health benefit when administered in adequate amounts. Postbiotics are preparations of inanimate microorganisms and/or their components that confer a health benefit. Because the microorganisms have been inactivated, postbiotics are more stable during storage than typical probiotics.

Does a product that already has a Thai FDA number still need clinical data?

The Thai FDA number of a dietary supplement is based mainly on an assessment of safety and quality; it does not confirm that the product has the health effect shown on its label. If you want to communicate an effect on gastrointestinal health, clinical data provide supporting evidence, and advertising must still comply with food law.

Can study results for another strain be cited instead?

No. Probiotic effects are strain-specific, so results demonstrated for one strain cannot be cited for another. Each study therefore has to be designed for the formula of the specific product.

Which tools are used to measure outcomes?

Standard assessment tools accepted in clinical research, such as the Gastrointestinal Symptom Rating Scale (GSRS), the Bristol Stool Form Scale (BSFS) and a tolerability diary, together with recording of adverse events throughout the study.

What is VISBIO’s role in a study, and who looks after the volunteers?

VISBIO designs the study and provides project management and coordination in collaboration with a network of partner clinical research sites and hospitals. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.

Do study results guarantee advertising approval?

No. Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.

If you are interested in a clinical trial for your probiotic or postbiotic dietary supplement, contact VISBIO for a free initial consultation through any of these channels:

• Contact form: https://visbio.co.th/en/contact-us/
• LINE Official Account: @visbio
• Email: service@visbio.co.th
• Phone: 098-635-4197
• Timeline: please ask our team directly.

See all clinical trial services on VISBIO’s clinical trial service page.

• VISBIO’s role: VISBIO designs studies and provides project management and project coordination in collaboration with a network of partner clinical research sites and hospitals, for sponsors in Thailand and abroad. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.
• Research ethics: Every study in humans starts only after approval by a human research ethics committee and is conducted under Good Clinical Practice (GCP). Every volunteer signs an informed consent form after receiving complete information.
• Drugs and herbal medicines: Studies must follow the Thai FDA requirements that apply to the product. The sponsor, the research site and VISBIO plan these steps together from the start of the project.
• Use of results: Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law for each product type, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.
• Foods and dietary supplements: Study results are not a claim that a product diagnoses, treats, cures, mitigates or prevents any disease.
• Timeline: This depends on the study design and the approval process. Please ask our team directly.

References:

1. Hill, C., Guarner, F., Reid, G., Gibson, G. R., Merenstein, D. J., Pot, B., Morelli, L., Canani, R. B., Flint, H. J., Salminen, S., Calder, P. C., & 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 and Hepatology, 11(8), 506–514. https://doi.org/10.1038/nrgastro.2014.66
2. Lewis, S. J., & Heaton, K. W. (1997). Stool form scale as a useful guide to intestinal transit time. Scandinavian Journal of Gastroenterology, 32(9), 920–924. https://doi.org/10.3109/00365529709011203
3. Salminen, S., Collado, M. C., Endo, A., Hill, C., Lebeer, S., Quigley, E. M. M., Sanders, M. E., Shamir, R., Swann, J. R., Szajewska, H., & Vinderola, G. (2021). The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nature Reviews Gastroenterology and Hepatology, 18(9), 649–667. https://doi.org/10.1038/s41575-021-00440-6
4. Svedlund, J., Sjödin, I., & Dotevall, G. (1988). GSRS — A clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Digestive Diseases and Sciences, 33(2), 129–134. https://doi.org/10.1007/BF01535722