RCTs the only way for probiotic acceptance, says leading professor

By Will Chu

- Last updated on GMT

Dr Ingvar Bjarnason was speaking at Probiota in Amsterdam last week to highlight the importance of proving probiotic quality.
Dr Ingvar Bjarnason was speaking at Probiota in Amsterdam last week to highlight the importance of proving probiotic quality.

Related tags Medicine

The only way probiotics will be accepted into mainstream medicine is to conduct randomised clinical trials that conform to drug standards, a leading gastroenterologist has said.

Professor Ingvar Bjarnason, a practicing gastroenterologist at King's College Hospital, London Bridge Hospital and the Cromwell Hospital, spoke at Probiota in Amsterdam last week on the importance of proving probiotic quality and efficacy to regulators.

Currently, probiotic products are not consistently tested for purity, viability or effectiveness and accompanying evidence of efficacy is rarely from well-designed, randomised, placebo-controlled trials, he said.

He highlighted the need for probiotic studies to be conducted at full clinical standards, investigator-led, placebo controlled and ethics and R&D approved.

“In my mind, this is the only way to get acceptance with probiotics,” ​he said.

“Otherwise it just becomes a marketing issue and won’t be sustainable."

Bjarnason gave the audience an overview of problems currently blighting probiotics’ medical standing. These included the raft of unsubstantiated medical benefit claims in the press and media and a lack of randomised clinical trials.

Trials conducted often that lacked a placebo component, further adding to regulator’s frustrations of poorly designed trials and non-standardisation of outcome measures.

He commented on the ‘wild claims’​ made by non-industry observers, who believed obesity or mental health was determined by your gut.

“It doesn’t make any sense. For medics this is quackery to the nth degree,”​ he said. “There is resentment out there.”  

Bjarnason’s comments echoed those of EFSA’s Dr Yolanda Sanz, who also spoke at Probiota​. She said microbiota changes should be linked to physiological or clinical outcomes of which a direct effect on human health could be attributed to a specific mechanism of action.

She added that hard health endpoints, not just changes to the microbiota, were needed to secure EU health claims.

Current studies submitted to EFSA showed food constituents increased gastro-intestinal microbiota but were unable to show such a change would result in a beneficial physiological effect.

probiota americas

Did you miss this year's Probiota conference in Amsterdam?

Have no fear, IPA World Congress & Probiota Americas 2016 will take place in Chicago May 31 – June 2. Find out more HERE​.  

Related news

Show more

Related products

show more

Immune support for everyone

Immune support for everyone

Content provided by Kerry | 12-May-2023 | Infographic

Consumers of all ages cite immune health as a top benefit driving their purchases, along with improving gut/digestive health.

Metabolic Health Starts in the Gut Microbiome

Metabolic Health Starts in the Gut Microbiome

Content provided by ADM | 10-May-2023 | White Paper

Emerging clinical evidence suggests that BPL1™ Probiotic and BPL1™ Postbiotic may effectively support aspects of metabolic health.

LIPOFER™: a bioavailable and stable source of iron

LIPOFER™: a bioavailable and stable source of iron

Content provided by Lipofoods, a Lubrizol Company | 26-Apr-2023 | White Paper

Maintaining adequate iron levels is critical to maintaining a healthy body, with deficiencies being the cause of several health issues including anemia...

Related suppliers

1 comment

Bias confirmation

Posted by Howard Cash,

More confirmation that EFSA's bias against probiotics is based in their insistence that RCTs designed for single molecule drugs with primarily one physiological activity is the gold standard for determining the activities of a class of living organisms that interact with both humans and their resident microbiomes and additionally may alter the way the host and their microbiome interact. Certainly an instance of if your only tool is a hammer then you will treat everything as if it were a nail.

Report abuse

Follow us

Products

View more

Webinars