CompletedNot Applicable

Assessment of the Effects of Probiotic Supplementation on Gut Microbiota Composition and Short-chain Fatty Acid Production in Frail Elderly Patients Receiving Home Enteral Nutrition With an Oligomeric Formula.

Italy27 participantsStarted 2018-06-21

Plain-language summary

This is an investigator-initiated, spontaneous, non-profit, randomized intervention study with two parallel arms. The study aims to evaluate the effect of a 30-days probiotic supplementation on the composition of the intestinal microbiota (MA) and the production of short-chain fatty acids (SCFAs) in faecal samples of frail elderly patients receiving home enteral nutrition (HEN) with an oligomeric formula. Participants will be monitored for gastrointestinal complications like constipation and diarrhea, and for Clostridium difficile infections.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Use of oligomeric enteral formula since at least 30-days * Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis). Exclusion Criteria: * Antibiotic use within one month prior to enrolment * Intake of any probiotics other than the study product within one month prior to enrolment * Hypersensitivity to any probiotic ingredient * Non-exclusive enteral nutrition (minimal oral intake)

What they're measuring

Change in the gut microbiota composition

Timeframe: from the enrolment to the end of study at 30 days

Change in the production of SCFA

Timeframe: from the enrolment to the end of study at 30 days

Trial details

NCT IDNCT07437352

SponsorIstituto Nazionale di Ricovero e Cura per Anziani

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

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