EFSA rejects Clasado prebiotic for gastro benefits (again)

By Shane Starling

- Last updated on GMT

Related tags: Gastroenterology, Gut flora

EFSA rejects Clasado prebiotic for gastro benefits (again)
Clasado has had its Bimuno prebiotic formulation rejected by the European Food Safety Authority (EFSA) which said fresh data analysis provided by the UK-Maltese firm did not show gastro-intestinal benefits.

Clasado submitted the claim that Bimuno could, “reduce bloating, flatulence and abdominal pain. These effects can be described collectively as abdominal discomfort”​ in normal adults under article 13.5 of the EU nutrition and health claims regulation (NHCR).

But EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said, “The supplementary information submitted by the applicant in this application did not provide evidence that could be used for the scientific substantiation of this claim.”

The NDA additional analysis of two studies did not address limitations of the studies such as short intervention periods, high drop-out rates and multiple outcomes.

Of one of the studies (Silk, 2009) it said additional analysis, “consists of weekly values for some secondary outcomes which were only reported and analysed for the baseline,  end-of-placebo, and end-of-treatment time points in the original study.”

“The Panel notes that in providing this additional information, the applicant did not address the important methodological limitations (e.g. high dropout rate, multiplicity of outcomes not taken into account in the dataanalysis, statistical methods and results insufficiently described, and no ITT analysis) of the study thatwere identified by the Panel in its previous Opinion.”

Clasado’s dossier focused on five human intervention studies, three non-human studies and one systematic review.

Bimuno GOS is a blend of β-galacto-oligosaccharides, derived from lactose conversion using Bifidobacterium bifidum ​NCIMB 41171 enzymes.

No prebiotic or probiotic is yet to win a positive EFSA opinion for any health benefit although the International Probiotics Association (IPA) announced this week it has sent a series of evidence requirement-related questions to EFSA and expects to meet with the agency.

The latest NDA opinion can be found here​.

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