scholarly journals Assessment of Benefits and Risks of Probiotics in Processed Cereal-based Baby Foods Lactobacillus Paracasei ssp. Paracasei F19

Author(s):  
Ragnhild Halvorsen ◽  
Jørgen Lassen ◽  
Tore Midtvedt ◽  
Judith Narvhus ◽  
Jarle Rugtveit ◽  
...  

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of Lactobacillus paracasei ssp. paracasei F19 (F19) in processed cerealbased baby foods intended for small children 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search.    A notification regarding two products of processed cereal-based baby foods (hereafter called cereals), intended for small children and supplemented with the bacterium F19 initiated this work.   A daily supply of a monoculture of a particular bacterial strain in large quantities to an age group without a fully established intestinal flora, may have unknown adverse effects. There are however, to our knowledge, no studies investigating possible short or long term adverse health effects of F19 in processed cereal-based baby food given to children 13 months onwards.   The documentation and information provided by the notifier regarding the genetic stability of F19 in the two products during processing and storage, is considered insufficient and does not allow any conclusions to be drawn.    Moreover, the documentation obtained is not conclusive regarding the antibiotic resistance pattern of the bacterial strain used in the products in question, as the information on different antibiotics is partly inconsistent. The information about specific localization (chromosomal, plasmid) of the resistance genes is not sufficient.    Studies demonstrate that F19, as well as other bacterial strains considered probiotic, is able to “crosstalk” with enterocytes in mice and that the result of the “crosstalk” depends upon the microbiota present. Whether F19 has a similar “crosstalk-profile” in humans is unknown. However, as the strain is originally of human origin, it seems reasonable to assume that such “crosstalk” may occur. Thus, before giving F19 daily for months and years, it seems reasonable to ask for additional molecular and physiological studies to unravel the functional impact of possible changes in genetic expression in children.    Lactobacillus infections do occasionally occur, mainly as bacteremia, endocarditis and localized infections (e.g. abscesses, peritonitis, and meningitis) in patients with severe underlying diseases. Most of them are elderly, but children are not excluded. The species most often isolated are L. casei and L. rhamnosus, followed by L. paracasei.    The increasing use of immunosuppressive therapy and broad spectrum antibiotics which are ineffective against Lactobacillus, might increase the importance of these bacteria as possible pathogens. In order to be able to draw any conclusions regarding beneficial effects of F19, there is a need for randomized placebo-controlled studies in larger populations and in the relevant age group.    According to EFSA, Lactobacillus paracasei ssp. paracasei F19 is sufficiently characterized. The documentation provided is, however, not sufficient to claim positive health effects and thus F19 is not proven to be probiotic.    There are no published dose-response studies of F19 in children, neither regarding survival of F19 in the gastrointestinal tract, nor possible negative health effects. Thus the potential for negative health effects as e.g. spreading of antimicrobial resistance or unfavourable impact on the genetic expression in children related to the frequency and/or dose of a monoculture of F19 cannot be assessed.

Author(s):  
Ragnhild Halvorsen ◽  
Judith Narvhus ◽  
Jørgen Lassen ◽  
Tore Midtvedt ◽  
Jarle Rugtveit ◽  
...  

The Norwegian Scientific Committee for Food Safety (VKM) has appointed an ad hoc-group of experts to answer a request from the Norwegian Food Safety Authority regarding benefit and risk assessment of B. lactis Bb12 in baby foods focusing on the age groups 4-6 months, 612 months and 1-3 years. This assessment is based on the literature provided by the notifier as well as that found by a MEDLINE search.    An notification for use of processed cereal-based baby foods (from now on called cereals) intended for infants and small children supplemented with the microorganism Bifidobacterium lactis (B. lactis) Bb12 in Norway initiated this work.     Studies of potential hazards and positive health effects from cereals containing B. lactis Bb12 intended for infants and young children have not been reported in the available literature. However, reports on safety of and positive health effects from infant and follow on formula supplemented with B. lactis Bb12 are available and have been assessed by VKM. In most of these clinical studies B. lactis Bb12 was administered in combination with other probiotic strains.   Clinical studies report no serious adverse events of infant formula supplemented with B. lactis Bb12. The effect of long term daily consumption of such supplemented formula by the actual age groups is not known.   A few studies have demonstrated some effect of supplementing baby food with probiotics, including B. lactis Bb12, on diarrhoea and atopic eczema while other studies do not show such effects. Thus, the scientific evidence for a favourable effect of supplementing formula or solid food with B. lactis Bb12, is weak and in some cases lacking.    There are no studies demonstrating a positive effect of cereals supplemented with B. lactis Bb12 intended for infants and small children.   Several health claims related to probiotics have been assessed by EFSA, including claims on reduction of gastro-intestinal discomfort, normal functioning of the alimentary tract, building of the natural intestinal barrier, improvement of the general immunity, mental and cognitive developments of children and immune system of children during growth. In the opinions so far, EFSA has concluded that a cause and effect relationship has not been established between the consumption of the probiotic containing products and the claimed effect. None of the products assessed so far contained B. lactis Bb12 (1 November 2009).   Commercially produced cereals are frequent given to infants and small children in Norway from an early age and this is particularly important for the establishment of the intestinal bacterial flora and the development of the intestinal mucosal immune system. According to the notifier, one portion (25gram) of the cereal powder contains 1 x 109 B. lactis Bb12 in monoculture. Taking into consideration that the daily intake is often greater than one portion of cereals, even in infants below 6 months of age, this would represent a daily intake of 1-2 x 109 cfu B. lactis Bb12 for an infant 4-6 months and even more in infants above 6 months. If a considerable amount of the B. lactis Bb12 survives the transport to the small intestine, it would represent a dominating and monocultural supply, often several times a day, to the small intestine.  The immaturity and vulnerability of the intestinal microbiota and the immune system makes the two lowest age groups, 4 – 6 and 6 – 12 months, at the highest risk of unwanted health effects due to the daily intake of probiotics.  


PEDIATRICS ◽  
1965 ◽  
Vol 36 (3) ◽  
pp. 314-321
Author(s):  
A. B. Bergman ◽  
H. Shrand ◽  
T. E. Oppé

RECENT YEARS have seen a resurgence of interest in organized Home Care programs as a variety of factors have spurred the search for alternatives to hospital care. Chief among them has been the economic burden of spiraling hospital costs. Many programs have been devised to enable chronically ill persons in the older age group—the "home-bound" geriatric patient—to be supervised in their own homes. There are, however, special reasons for attempting to control the admission of children to hospitals. Illness is a time when a child becomes more dependent than usual and seems to need the security of parents and the comfort of familiar home environment. Even though enlightened hospitals now encourage visiting, many parents cannot take advantage of this for such reasons as distance and having to care for the other children at home. There is debate as to the amount of emotional harm caused by hospitalization of small children; most workers would say it does no good, and, in some cases, can lead to serious sequelae. The Home Care Program for sick children at St. Mary's Hospital in London was started in April, 1954. One of us (A.B.B.) had the opportunity of participating in this program in 1961 while serving as an Exchange Registrar from Children's Hospital (Boston). It is felt that even though conditions in the United States and Great Britain may be different, there are enough similarities to make a descriptive account of the program of interest to American physicians. The Development of Home Care Schemes Historically, doctors looked after the sick in their own homes when private fees could be afforded.


Author(s):  
Martinus Løvik ◽  
Livar Frøyland ◽  
Margaretha Haugen ◽  
Sigrun Henjum ◽  
Kristin Holvik ◽  
...  

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating "other substances" in food supplements. "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/ or physiological e ffect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances" the VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects. The present report is a risk assessment of specified doses of L-threonine in food supplements, and it is based on previous risk assessments and articles retrieved from literature searches. According to information from NFSA, L-threonine is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of 1000, 1200, 1500, 2000 and 2400 mg/day of L-threonine from food supplements.  L-threonine is an essential amino acid not known to cause any adverse health effects. Previous reports do not indicate a tolerable upper intake level, apart from an approval of a dose of 1150 mg/day by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN). Long-term studies in humans were not found. The only available human studies were: a small uncontrolled one-year pilot study with doses ranging from 0.5 to 2.5 g/day, one eight-week randomised controlled trial (RCT) using a dose of 7.5 g/day, and two 2-week RCTs using doses of 6 and 4.5 g/day. No adverse effects (diary method of registration of adverse effects) were reported in the eight-week clinical trial, and the only adverse effects observed in the two-week trials were one case of indigestion and one case of diarrhoea. A four-week rodent toxicity study indicated a no observed adverse effect level (NOAEL) of 854.3 mg/kg bw per day (only dose tested, no adverse effects observed).  The value used for comparison with the estimated exposure in the risk characterisation is the NOAEL defined in an 8-week randomised placebo controlled study in humans, 7500 mg/day. For a 70-kg individual, this corresponds to 107 mg/kg bw per day. Two human two-week studies and a small one-year pilot study support the notion that this dose will be well tolerated. The overall mean threonine intake according to NHANES III (3 g/day) is slightly larger than the doses requested for evaluation in the present risk assessment. No studies in children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects the tolerance for relevant doses of threonine. Therefore, in this risk characterisation a tolerance as for adults, based on body weight, was assumed for these age groups. VKM concludes that: In adults (≥18 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. In adolescents (14 to <18 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. In children (10 to <14 years), the specified doses 1000, 1200, 1500, 2000 and 2400 mg/day L-threonine in food supplements are unlikely to cause adverse health effects. Children younger than 10 years were not within the scope of the present risk assessment.


2021 ◽  
Author(s):  
Motunrayo Ganiyat Akande

Legumes have high nutritional value and they are important sources of protein, carbohydrates, fats and dietary fiber. The contamination of legumes with pesticides and heavy metals has been reported in scientific literature. Human beings are mainly exposed to the residues of pesticides and heavy metals through the dietary route. The purpose of this review chapter is to highlight the acute and chronic health risks that human beings may be exposed to as a result of the ingestion of legumes polluted with pesticides and heavy metals. Additionally, the mechanisms through which pesticides and heavy metals engender different undesirable health outcomes in human beings were stated. Scientific literature were perused and the information contained in them were collated to derive this chapter. Pesticides cause short-term health effects including hypersensitivity and mortality, while heavy metals induce acute effects like seizures and death. Some chronic untoward effects of pesticides are congenital disabilities and neurological damage. Heavy metals elicit disorders like anemia, hypertension and cancer. It is envisaged that the findings documented in this review will create awareness of the health risks posed by the contamination of legumes with the residues of pesticides and heavy metals so that food safety measures can be enforced globally.


2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Stephen T. Odonkor ◽  
Napoleon Kurantin ◽  
Anthony M. Sallar

Food safety has become a global issue due to the morbidity and mortality associated with it, particularly in developing countries. The objective of this community-based study is to examine food safety practices and its associated factors among postnatal mothers in the Western Region of Ghana. A cross-sectional survey study was conducted from August 1 2019 to January 31, 2020 from which data was obtained from the postnatal mothers ( N = 300 ). The data was analysed using SPSS v.23. The findings suggest that majority (86%) of the respondents exhibited good food handling practices. Also, 66.3% and 91.7% of the respondents exhibited good food preparation and proper storage practices, respectively. Results also revealed that the odds of performing good handling practice among respondents within the age group of 36-45 years were five times higher compared to those within the age group of 18-25 years [ OR = 4.92 (95% CI: 1.44–16.86), p = 0.011 ]. Moreover, respondents who had tertiary education qualifications were more likely to have proper food handling practices compared to those with primary education [ OR = 0.27 (95% CI: 0.09–0.71), p = 0.009 ]. These findings provide useful insights for policy directions. The government of Ghana and other stakeholders should develop a communication strategy to increase and sustain publicity and education on food safety particularly to postnatal mothers and the citizenry in general.


1989 ◽  
Vol 8 (5) ◽  
pp. 360-375 ◽  
Author(s):  
J Dupont ◽  
P J White ◽  
K M Johnston ◽  
H A Heggtveit ◽  
B E McDonald ◽  
...  

2021 ◽  
Vol 56 (3) ◽  
pp. 159
Author(s):  
Mohammad Akbaruddin Sholeh ◽  
Kuntaman Kuntaman ◽  
Usman Hadi

Resistance to antibiotics is increasing worldwide, including in Indonesia. The use of antibiotics is the most common cause of microorganism resistance. Individuals who received antibiotic therapy impacton changes of normal micro-flora resistance through selective pressure. This study aims to analyze the relationship of the quantity of antibiotic use with the pattern of resistance of gut normal flora Escherichia coliamong patients in Intensive Care Unit (ICU) and Tropic Infection Ward, Dr. Soetomo Hospital, Surabaya. This study was cross-sectional design with 64 samples (32 the ICU and 32 in Tropic Infection Ward). The total sample were collected for three Months. Identification of intestinal microflora was done with McConkey differential selective medium, followed by IMViC biochemical test, and sensitivity test by antibiotic disc diffusion method. Data were analyzed with Chi square test and Fisher'sExact test. There was no significant difference (p=0.441) in the quantity of antibiotic use between ICU and Tropic Infection Ward. There was no significant difference (p>0.05) in normal intestinal flora Escherichia coli resistance pattern between Tropic Infection Ward and ICU against12 types of antibiotics. Ceftriaxone was the most widely used antibiotic in the Tropic Infection Ward of 54 DDD and ICU of 100 DDD. The highest percentage of intestinal flora Escherichia coli  resistance at the ICU was ceftriaxone as manyas 18 (56.3%) and at Tropic Infection Ward on ciprofloxacin and levofloxacin 20 (62.5%). The other study in Primary Health center, showed that theresistance rates of both wards were significantly different as compared to intestinal flora of patients in primary health center (p <0.001), in whichthe use of antibiotics in primary health center was also lower (1.6 DDD). There was no significant difference (p>0.05) The pattern of bacterial resistance between patient with and without antibiotic use at Tropic Infection Ward and ICU Conclusion: the quantity of antibiotic use was not significantly different against resistnt gut flora between patients in ICU and Tropic Infection ward. The pattern of bacterial resistance between patient with and without antibiotic use was also not significantly different.


Author(s):  
Livar Frøyland ◽  
Margaretha Haugen ◽  
Kristin Holvik ◽  
Martinus Løvik ◽  
Tor A. Strand ◽  
...  

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of "other substances" to food supplements.  "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.  The present report is a risk assessment of L-phenylalanine and DL-phenylalanine and is based on previous risk assessments. According to information from the Norwegian Food Safety Authority, L- and DL-phenylalanine are ingredients in food supplements sold in Norway. NFSA has requested a risk assessment of the following doses of L-phenylalanine and DL-phenylalanine in food supplements: L-phenylalanine 100, 250, 500, 750 and 1000 mg/day and DL-phenylalanine 50 and 75 mg/day.  L-phenylalanine is an essential amino acid which means it has to be obtained from the diet. Amino acids are building blocks for proteins and present in protein rich food such as milk, meat, fish, eggs and cheese.  No data on adverse health effects after chronic ingestion of supplemental phenylalanine in apparently healthy subjects are available, thus no tolerable upper intake level (UL) can be established. Patients with phenylketonuria (PKU), a genetic disorder that impairs phenylalanine hydroxylase (PAH), an enzyme involved in the metabolism of phenylalanine, must keep plasma levels of phenylalanine low in order to maintain normal growth and brain development. In Norway, all newborns are routinely screened for PKU three days after birth.  The mean dietary intake of phenylalanine in the EU population range from 0.4-4.1 g/day corresponding to 79.0 mg/kg bw per day for adolescents (10-17 years) and 58.7 mg/kg bw per day for adults, respectively (EFSA, 2013). The sweetener aspartame contains phenylalanine. Taking the molecular weight of phenylalanine into account, the proportion of to phenylalanine exposure from aspartame is 56%. The ADI of 40 mg aspartame/day/kg bw (providing 22.4 mg phenylalanine/day/kg bw) JECFA (1981) was re-evaluated and maintained in 2013, based on the notion that elevated plasma levels of phenylalanine in pregnant women leads to developmental toxicity in their children (EFSA, 2013).  The literature search did not provide novel information on adverse health effects related to intake of L-phenylalanine and no information related to DL-phenylalanine.  VKM concludes that:  In adults (≥ 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. In adolescents (14 to < 18 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. In children (10 to < 14 years), the specified doses 100, 250, 500, 750 and 1000 mg/day L-phenylalanine in food supplements are considered unlikely to cause adverse health effects. Although the highest dose provides 23 mg/kg bw per day which slightly exceeds 22.4 mg/kg bw per day, it is considered unlikely to cause adverse health effects in healthy children 10 to < 14 years. None of the above conclusions are applicable for patients with phenylketonuria (PKU). No conclusion can be made regarding DL-phenylalanine.  Children below 10 years were not included in the terms of reference.


1999 ◽  
Vol 79 (4) ◽  
pp. 533-538 ◽  
Author(s):  
M. A. Miller

This paper discusses the new animal drug approval process regulated by the Center for Veterinary Medicine (CVM), Food and Drug Administration (FDA) of the United States. The Center for Veterinary Medicine of FDA considers two criteria in ensuring the human food safety of edible animal products: i) safety of the chemical residues and ii) for antimicrobial products, microbiological safety including changes in bacterial pathogen load and resistance pattern. The hazard associated with animal drug products of non-carcinogenic compounds is assessed by conducting a standard battery of toxicology test, whereas the hazard from the carcinogenic potential of compounds is evaluated based on structure, results of genetic toxicity tests, and toxicology studies. Post approval monitoring is carried out to ensure that the animal drugs are being used properly after their approval. Particular concern is given to those eliciting an "acute" toxic reaction at relatively low levels. The other aspect of food safety regulated by CVM of FDA is microbiological safety, especially to antimicrobial drugs used at subtherapeutic levels in feeds. The studies are designed by FDA to ensure that antibiotic treatment of food-producing animals does not alter pathogen load or resistance pattern of pathogens. Two studies are generally performed: i) the salmonella shedding study, which addresses the effect of drug treatment on the excretion of salmonella in the feces of animals artificially infected with salmonella; and ii) the coliform resistance study, which monitors the effect of the drug on the resistance pattern of E. coli present in the endogenous fecal flora. After a retrospective study of the microbiological safety over past 20 yr, CVM of FDA is planning to revise some microbiological safety studies with focuses on: i) pathogen load, pathogen excretion and microorganism resistance pattern at the time of slaughter; and ii) susceptibility studies on products that have utility in human medicine. Key words: Animal drug, food safety, antibiotic


2022 ◽  
Vol 370 ◽  
pp. 131101
Author(s):  
R. Calderón ◽  
C. Jara ◽  
F. Albornoz ◽  
P. Palma ◽  
N. Arancibia-Miranda ◽  
...  
Keyword(s):  

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