Safety of viable embryonated eggs of the whipworm Trichuris suis as a novel food pursuant to Regulation (EU) 2015/2283

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a food supplement in the format of a 15‐mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.

Helminth Lessons in Inflammatory Bowel Diseases (IBD)

“…Intestinal colonization with helminths triggers a type 2 immune response in animal models [ 77 , 78 ] and patients [ 79 ]. In this framework, animal models of helminth infections have played a critical role in understanding immune regulation in IBD in addition to other immune disorders ( Table 2 ).…”

Recognition of highly branched N-glycans of the porcine whipworm by the immune system

“…As a parasite that generally does not have a productive lifecycle in humans, T. suis has attracted attention as a potential unorthodox therapy for such diseases and its eggs have been administered to patients with Crohn's disease and autoimmune rhinitis as well as to animals with experimental autoimmune encephalomyelitis (17)(18)(19) . While the effects and safety of such therapies are controversial (20) , it is clear that T. suis excretory-secretory products do exert typical immunomodulatory effects, which are partly glycan-dependent (21) . With this background and to investigate interactions of T. suis glycans with components of mammalian immune systems, we have established the first microarray of natural glycans of this species, accompanied by an in-depth study of its N-glycomic capacity.…”

Recognition of Highly Branched N-Glycans of the Porcine Whipworm by the Immune System

“…As a parasite that generally does not have a productive life-cycle in humans, T. suis has attracted attention as a potential unorthodox therapy for such diseases and its eggs have been administered to patients with Crohn’s disease and autoimmune rhinitis as well as to animals with experimental autoimmune encephalomyelitis ( 23 , 24 , 25 ). While the effects and safety of such therapies are controversial ( 26 ), it is clear that T. suis excretory-secretory products do exert typical immunomodulatory effects, which are partly glycan-dependent ( 27 ). Examples of proteins secreted by Trichuris spp.…”