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

May the use of probiotic supplements in older patients treated with enteral nutrition reduce infections and inflammation?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75739497

Enrollment

Registered

2020-07-09

Start date

2018-10-02

Completion date

Unknown

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical infections and inflammation in older subjects treated with home enteral nutrition Infections and Infestations

Interventions

A total of 32 subjects will be randomly assigned to the intervention group (16) or to controls (16). The Proxian® probiotic supplement will be administered to the intervention group for 60 days. Proxi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) 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	—

Measure

Time frame

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) 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

—

Secondary

Measure	Time frame
1. Nutritional status is assessed by Body Mass Index values assessed at baseline, 45 and 90 days after the enrollment 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 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	—

Measure

Time frame

1. Nutritional status is assessed by Body Mass Index values assessed at baseline, 45 and 90 days after the enrollment 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 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

—

Countries

Italy

Contacts

Public ContactNikolina Jukic Peladic

t.nutrizionale@inrca.it+39 (0)71 8003327

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026