Lactic acid bacteria (LAB) in intestinal flora are useful in maintaining good health. Recently, it has been reported that LAB act on the immune mechanism and increase the body's resistance to infection, cancer and allergy. In this paper, it was showed that oral administration of Bifidobacterium breve YIT4064 (B. breve) to mice activated the humoral immune system, augmented anti-rotavirus IgA production or anti-influenza virus (IFV) IgG production and protected against rotavirus infection or influenza infection, respectively. Furthermore, when the B. breve was given to infants, there was a significant reduction of the frequency of rotavirus shedding in stool samples during the administration of the bacteria. It was also found, again using mice, that oral administration of Lactobacillus casei strain Shirota (LcS) stimulated type 1 helper T (Th1) cells, activated the cellular immune system, inhibited incidences of tumors, influenza infection and IgE production. In the human study, it was demonstrated that oral administration of LcS into surgical operated patients suppressed the recurrence of superficial bladder cancer in a double-blind clinical trial. On the basis of both our data and the data of other authors, it was showed that some strains of Bifidobacterium and Lactobacillus had immunomodulatory activities and were able to protect against various diseases.

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Polydextrose has been reported to promote bowel elimination. The clinical efficacy of polydextrose administered at a daily dose of 7g for 30 days was examined in 23 patients with habitual constipation and melanosis coli found by total colonoscopy. After the start of treatment with polydextrose, 13(56.5%) of the 23 patients noted improvement in constipation (dyschezia). The stool consisitency of stools improved in 17 (85.0%) of 20 patients having had hard stools. The frequency of defecation increased in 13 (81.3%) of 16 patients who of fecal properties. After the use of polydextrose for 30 days, the effects of polydextrose was noted in 20(87.0%) of the 23 patients in total as (1) improvement in constipation, (2) increased frequency of defecation, (3) softened the stool consisitency, (4) improvement in other bowel symptoms, or (5) reduced laxative dose, or two or more of those. These results indicated a clinical effects of polydextrose for the treatment of habitual constipation in patients with melanosis coli.

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Authors have already reported that administration of 1200mg/day of Chitosan (twice a daily three capsules at each time) significantly reduced serum total cholesterol (p=0.04) compared with placebo group in a double blind manner for 2 months without concomitant diet therapy. This study was investigated efficacy and safety in the case that 1.200mg of Chitosan in the capsulated form was consecutively administrated to the subjects after double blind test without washout term and concomitant diet therapy under the informed consent. Reduction of total serum cholesterol was observed significantly in two (n=30) and four (n=35) month's treatment (p=0.0014, p=0.0025) respectively by repeated-measure ANOVA. In the group with the values beyond the maximum of reference value of total cholesterol before chitosan treatment, the mean relative change of cholesterol [(base line-after treatment)/base line] decreased about 5% by administration for two months or more. On the other hand it almost unchanged in the group with the values within the reference value of total cholesterol. Chitosan has been approved as specific food additive for hyperlipidemia up to now. In the present experiments, capsulated chitosan was shown to have anti-hyperlipidemia activity as well as that used as food additive. Adverse food additive reactions (AFAR) were observed as 2 affairs (1 case) in the 2-month group and 5 affairs (4 cases) in the 4-month group. Over-all frequency of AFAR was 7.7%(5/65) and AFAR with highest frequency was 4.6%(3165) in thirsty. Over load study using three times of the amount described above (3600mg/day) did not show serious AFAR and adsorption of vitamin E for 14 consecutive days. In conclusion, 1200mg/day of capsulated chitosan was confirmed to have efficacy and have no severe AFAR in four month's administration study and its over load test. Usual dose of capsulated chitosan was considered safety as well as the food additive.

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Food for specified health uses is permitted one by one, and the specific health effect has to be certainly based on the scientific evidences. These evidences must be based on the results from the experimental protocol and be gotten under several experimental regulations. It has not been clarified whether the result of specific health effects are replicated and applicable or not, in the case of availableness on usual life. Oligosaccharides and sugar alcohols have the beneficial health effects and are often used for the ngredients of the food for specified health uses. The aim of this study is to estimate the replicability of the effect on the improvement of fecal conditions, when galactosylsucrose-containing food for specified health uses is ingested on the usual life. The subjects of this study (51 females, age; 20.1±2.1y.) have to ingest one package (48g, 12g×4 pieces) of the cookies type of food for specified health uses containing 4g of galactosylsucrose every day for 2 weeks. They have to ingest following the notice written in the package label, however, no experimental regulation is imposed on them. After 2 weeks ingestion, they report the questionnaire in terms of the effect on the fecal conditions including fecal frequency and comfortableness of defecation, fecal softness and odor, and satisfaction after defecate. There was tendency that 28 subjects (54.9%) improved the fecal frequency and 26 subjects (51.0%) improved fecal softness and comfortableness. Their frequency and comfortableness of defecation in 40 subjects with slight constipation were significantly changed better than that of in the subjects with normal defecation. These results suggested that the effect on the fecal conditions by ingestion of galactosylsucrose containing food for specified health uses is not so remarkable on the usual life.

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