Evaluation of the clinical effects of supplementation with probiotic supplement Proxian® in frail elderly patients treated with enteral nutritio

Not Applicable

Completed

• Conditions: Clinical infections and inflammation in older subjects treated with home enteral nutrition; Infections and Infestations

• Registration Number: ISRCTN75739497
• Lead Sponsor: IRCCS Istituto Nazionale Ricovero e Cura per Anziani

Brief Summary

2021 results in https://doi.org/10.3390/nu13020391 (added 27/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-30
• Study Start: 2020-07-09
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Age over 65 years
2. Patient treated with HEN for at least 1 month
3. No antibiotic therapy for at least 1 month before the enrollment
4. Written informed consent; for patients with a serious cognitive impairment the informed consent signed by legal administrator
5. Availability of a caregiver (formal or informal)

Exclusion Criteria

1. Diagnosis of pancreatitis
2. Known hypersensitivity to any ingredient contained in Proxian®
3. Participation in other clinical trials in 3 months previous to the invitation to participate in the study
4. Use of probiotic supplements in the period of 30 days previous to the enrollment
5. CRP hs> 10 mg / dL

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The onset of infections observed by detection of clinical manifestations of infections (prevalence) and antibiotic therapy (prevalence) during the period of administration and 90 days after the enrollment (30 days after the last administration)<br> 2. The inflammation is assessed by C Reactive Protein (CRP) values in the intervention group and in controls following the administration of products (Proxian® and placebo) and lab analyses will be performed at baseline, 45 and 90 days after the enrollment<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Nutritional status is assessed by Body Mass Index values assessed at baseline, 45 and 90 days after the enrollment<br> 2. Motility is assessed by the evidence on bowel function and its variations as reported by caregivers on the occasion of each phone contact with caregivers<br> 3. Compliance of caregivers and their perception of the product in different stages of administration (before and after) are assessed by specific questionnaires administered at the enrollment and after 60 days of administration<br>