Trial Protocol Essay

1836 words - 8 pages

2 Introduction
2.1 Investigational medicinal product
Agar-agar is commonly used as one of food ingredients among Asian countries such as China, Japan and the Republic of Korea. About 94% of agar-agar is dietary fibre and its consistents of agar-agar are agarose and agaropectine, which appear in a ratio of seven to three. In this study, powdered agar-agar is engaged because of its availability, particle size and better solubility.

2.2 Background (400 words)
Constipation is frequently seen among haemodialysis patients. Considerable causes of patients’ constipation are nutrient deficiencies specifically dietary fibre, fluid intake, and basal food and energy intake shortage since patients ...view middle of the document...

Reducing dietary concern might improve their appetite since aged patients may have difficulty of food swallowing due to aging or anamneses such as stroke and watery meals may be unproblematic to swallow down for these patients. This will be also an approach of malnutrition in dialysis patients as majority of they are elders and have low BMI or PEW (protein energy waste) stages.

2.3 Preclinical data
Main components of agar are agaroses and agaropectines (Armisen & Galatas, 2000) in detail, 3,4-anhydro-L-garactoses, D- galactoses and L-galactoses (Chi, Chang, & Hong, 2012), (Lahaye & Rochas, 1991). The origin of agar is in Japan in 1658 which is taken from seaweed and used at both industry and household as a gellagenncy or food additives as well as gelatin (Armisen & Galatas, 2000). Although it is one of the traditional and currently used food sources, very little studies have been done as a supplement source at medical situation.

2.4 Clinical data
More than two thirds of haemodialysis (HD) patients have constipation and half ratio of them have constipation on continuous ambulatory peritoneal dialysis (PD) treatment. In contrast, dietary fibre intake of PD patients is significantly higher than HD patients, which suggests that adequate dietary fibre intake is one of the effects to have regular defecation.
Studies reported that he ratio of constipation in HD patient is 2.2 to 4.2 times higher than PD patients and dietary fibre intake of HD and PD patients are 11.0 ± 4.0 g and 5.9 ± 2.9 g, respectively (Yasuda et al., 2002), (Zhang et al., 2013). Dietary fibre intake is one of the positive factors of defecation (Bosaeus, 2004). Therefore filling this gap seems to be a solution of constipation.

2.5 Rationale and risks/benefits
The primaly benefit of this study is improvement of constipation in haemodialysis patients since sufficient dietary fibre intake is suggested as a constipation preventable factor. (Yasuda et al., 2002)

Secondary expected benefit is excreting metabolised elements as dietary fibre intake decreased blood creatinine level in chronic kidney disease (Salmean et al., 2013), also, expansion of fluid intake allowance may be expected since agar keeps holding water in the faeces, which may unable to have opportunity of fluid intake from preference. This might also increase appetite as majority of aged haemodialysis patients can have difficulty of food swallowing due to aging or anamneses such as stroke.

This powdered agar-agar is widely, traditionally used as a food ingredient in Asia therefore this material is confirmed about its safety. Nevertheless, engaging haemodialysis patients requires their characteristics of clinical conditions since their filtering ability by kidney is lost and no urination (Kahn, 1999), (Kovesdy, 2012). One of the features of agar-agar is its ability of holding water thus monitoring and avoiding hypernatoremia is essential.

Additionally, normally dietary fibre is useful for excretion...

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