Feature

Lack of probiotics progress fails to slow gut health market

The digestive health market is full of life, ingredients makers claim

Research into the ability of probiotics to support healthy digestive function over the years has been significant.

Key points

But in the eyes of EU regulators at least, there is still a chink in the research chain that needs to be resolved before the food industry can capitalise on the apparent benefits.

“Clinical studies that show a significant beneficial effect on maintaining measurable clinical markers for digestive health are still needed thus providing conclusive evidence for scientific substantiation of claims in the EU,” says Susanne Andersen Bækgaard, vice president of marketing at probiotic firm Bifodan.

“A clear-cut link between specific groups of bacteria and their function in the digestive tract, as well as the signs of deficiency of these specific bacteria, has still not been established,” she concedes.

So, probiotic players will have to persist with clinical trials a little longer.

However, while progress in some areas of gut health appears to have stalled, innovation in others is starting to gather pace. Products carrying ‘stool frequency’ claims have made it to market, while ingredients that address digestive intolerance are beginning to make inroads.

More probiotics research is needed

Another probiotics company, Probi, admits more research in the field is required. “We need to understand who we can help – most likely not everyone,” says Johan Wahlqvist, marketing and sales director of Probi’s consumer healthcare division.

“We also need to understand the mechanism by which ‘responders’ are being helped by a probiotic strain.”

To this end, Probi is conducting major clinical trials on irritable bowel syndrome (IBS) and IBS-like symptoms. It is also starting to study the relationship between intake of its probiotic strains, microbiota composition and health effects.

However, despite recently revised guidance from the European Food Safety Authority (EFSA) on preparing scientific dossiers for gut health claims, there is still some uncertainty as to what that the assessor is looking for when it evaluates research.

Health claim application concerns

The International Probiotics Association (IPA) Europe has identified a number of shortcomings with the application process.

“There are several points that IPA Europe believes have not been adequately considered, for example, the possibility of having a dialogue between the applicant and EFSA prior to the submission of a dossier,” says Rosanna Pecere, executive director of the association.

“Another aspect is the discrepancy in what is stated in the guidance and what is practised by the panel, in particular relating to how meta-analyses are treated. Instead of accepting meta-analyses and their conditions, the panel insists on reviewing the primary data,” she adds.

This, Pecere says, is “unfortunate”, as meta-analysis gives greater weight to higher quality studies.

Anecdotal evidence suggests that even a less than perfect system isn’t deterring persistent applicants. Probi’s Wahlqvist, for instance, claims there are companies that are close to achieving enough information to submit a health claim application.

But for the meantime, the ongoing uncertainty surrounding the regulatory future of probiotics is not helping. Both the supplement and the yogurt categories experienced a sharp downturn in sales following the 2012 ban on the term ‘probiotic’.

Since then, according to Probi, supplements have bounced back, returning to “steady category growth”. However, Euromonitor estimates the ban will have cost the drinking yogurt category 1.5bn in lost sales by 2020.

Prebiotic use remains ambiguous

If the last few years have been a rough ride for probiotics, they haven’t exactly been plain-sailing for prebiotics. Like the term ‘probiotic’, the term ‘prebiotic’ can be considered an implied claim, and there is ongoing ambiguity around its use.

Roquette’s stance is that “prebiotics are – by definition – associated with an effect on health” and may therefore be “equated to an unauthorised claim in consumer communications”.

In contrast, Beneo refers to a 2010 EFSA opinion that the term prebiotic was not in itself considered to have a beneficial physiological effect.

“It is a matter of fact that chicory root fibres promote selective growth of specific parts of the microbiota – ie that they are prebiotic. This is scientific terminology and is based on fact,” says Anke Sentko, vice president of regulatory affairs and nutrition communication at Beneo.

“What can be stated on a label is a matter of interpretation of food legislation and is the responsibility of food makers.”

Chicory root fibre has a health claim

A prebiotic chicory root fibre used by Beneo has so far been one of the few health claim winners in digestive health.

In 2016, the ingredient, which includes inulin and oligofructose, was granted a 13.5 health claim submitted by Beneo thanks to its positive effect on bowel function.

Several products carrying the proprietary claim are now on sale in Europe. In the UK, for example, Eat Natural’s ‘better inside’ bars are promoted as containing chicory root fibre ‘to help support a healthy and balanced digestive system’, and Power Health’s inulin powder has ‘supports digestive health and promotes normal bowel function’ on its packs.

Interestingly, the word ‘prebiotic’ doesn’t get a mention, although Beneo doesn’t see this as a problem.

“While EFSA does not use the term ‘prebiotic’ in its opinion on inulin and improvement on stool frequency, the meaning of it is, in our opinion, addressed in its scientific acknowledgement of the studies with Orafti inulin as ‘showing the non-digestibility of inulin and inulin-type fructans in the small intestine and their fermentation in the colon, leading to an increase in total bacterial mass’,” says Sentko.

She also points to EFSA’s conclusion that chicory inulin ‘could exert an effect on stool frequency by stimulating bacterial growth in the gut and increasing bacterial cell mass and faecal bulk’ in support of this.

The suggested benefits of other fibre products

Roquette says its soluble fibre Nutriose has been “clinically proven” to have a positive impact on gut microbiota by increasing positive flora and reducing pathogens, although this effect isn’t supported by an EU-approved claim.

Nevertheless, the company says food manufacturers can promote the digestive health benefits of prebiotic ingredients such as Nutriose by using the nutritional claims for fibre content: ‘source of fibre’ or ‘high in fibre’.

Dutch firm Sensus says these claims are also made by customers using its chicory root fibres and “the power of such claims [to consumers] should not be underestimated”.

In a recent consumer survey commissioned by Sensus, 84% of respondents recognised that fibre intake is important for bowel and digestive health.

“The outcome identified a clear opportunity for the food industry to improve the fibre intake of consumers through the use of functional fibre ingredients, such as chicory root fibre,” says Elaine Vaughan, responsible for scientific and regulatory affairs at Sensus.

Fibre-rich wholegrains also help towards the intake of prebiotics, at the same time as having other digestive benefits, seeds specialist Edme claims.

The company recently launched Wholesoft, a sprouted wholegrain with a soft texture, making it possible to be used with yogurt.

Digestive tolerance improvement is a growing area

While they dominate, prebiotics and probiotics are not the only topics concerning digestive health.

“Digestive tolerance improvement is also key, especially given increasing food tolerances across the population,” says Laetitia Guerin-Deremaux, Roquette’s nutrition and health senior research manager.

Roquette’s Nutriose fits neatly with this trend, owing to its “outstanding digestive tolerance” of up to 45g per day with no side-effects.

Similarly, Sensus points out that chicory root fibre has hypoallergenic properties that lend it to use in gluten-free products, another growing digestive health benefit.

DSM also sees digestive tolerance as a potential growth area. “Pro- and prebiotics currently lead the category, but we expect it will become more diversified,” says Emily Tellers, programme director for gut health at DSM.

“While many consider digestive health to be about successful digestion in the intestines, we see a role for dietary enzymes to prevent digestive discomfort and stomach intolerances.”

The company’s Tolerase L, aimed at people who have difficulty digesting lactose, already has an EU-approved article 13.1 health claim.

Tolerase G, a gluten-degrading enzyme aimed at gluten-sensitive consumers, could be next, following positive signals from EFSA.

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