Clinical Trial
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[Study of tolerance and aceptability of a hyperproteic enteral formula enriched in fiber].

OBJECTIVES: To evaluate the gastrointestinal tolerance and acceptance of the new formulation of Isosource Protein ® Fibre® with a new blend of fibers IS50®.

METHODS: Opened, non-comparative, nonrandomized, descriptive study in patients requiring full enteral tube feeding for at least 7 days. Gastrointestinal tolerance was assessed by daily record of subjective gastrointestinal symptoms by the patient, and objectives behind the abdominal exploration by the researcher for up to 15 days.

RESULTS: 18 patients were included with a mean age of 67.32 ± 13.8 years, of whom 66.7% were male. The average actual weight of the sample was 68.7 ± 9.8 kg (range: 51-90 kg) and BMI 24.0 ± 4.0 kg/m2 (range: 16.0 to 32.00 kg/m2). The average volume prescribed Isosource Protein® Fiber® was 1580 ± 282.7 ml / day (range: 1200 to 2000 ml/day). 72.22% of the patients received 1500 ml/day, received 16.67% 1750 ml / day, 5.56% received 2000 ml/day and 5.56% received 2500 ml/day. The analysis of the gastrointestinal tolerance of patients revealed that in the first study visit, reported no significant gastrointestinal problems, only one patient indicated the presence of mild constipation. By contrast, in the last study visit, it was observed that two patients reported constipation (mild to moderate) and two patients reported diarrhea (mild and severe). As for the evaluation of gastrointestinal tolerance by the investigator and depositional habit, the results show that in 100% cases tolerance was normal. Regarding the depositional habit, it was observed than the 66.7% of patients had no bowel movements at baseline, compared to 33.4% at the last visit of the patient (p = 0.035). In this sense, a significant increase (p = 0.035) in the mean number of daily bowel movements at the final visit (0.89 ± 0.90, range: 0-3) was observed, compared to the initial visit (0.44 ± 0.78, range: 0-3).

CONCLUSIONS: Isosource Protein® Fibre® has proved a formula for enteral nutrition well tolerated, with a very low frequency of gastrointestinal symptoms and an improvement in the number of stools, which encourages compliance with the standard prescribed by the health professional and suggest a positive effect on the regulation of intestinal transit.

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