Assessment of the Effects of Probiotic Supplementation on Gut Microbiota Composition and Short-ch… (NCT07437352) | Clinical Trial Compass
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 range
65 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the gut microbiota composition
Timeframe: from the enrolment to the end of study at 30 days
2
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