Enteral NutritionMICROBIOTANCT07437352
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.
A study testing probiotic supplementation in people with Enteral Nutrition, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- probiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2018to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Use of oligomeric enteral formula since at least 30-days
- Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Enteral Nutrition
- Being tested
- probiotic supplementation
- Keywords
- older people, frailty, gut microbiota, short chain fatty acid, probiotic supplementation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic supplementationDietary supplement
Subjects take 1 capsule/die of the probiotic SYNBIO® (Synbiotec Srl, Camerino, Italy). Each capsule contains 0.26 g of a 1:1 mixture of Lactobacillus rhamnosus IMC501® and Lactobacillus paracasei IMC502®, equivalent to a daily dose of 15 billion live probiotic cells. For enteral nutrition, the probiotic powder was suspended into 5-10 mL of water and administered directly through the feeding tube. The product is gluten-free, lactose-free, and contains no milk proteins.
| Study group | Role | What they receive |
|---|---|---|
| probiotic supplementation arm | Experimental | The experimental arm consists of subjects on home enteral nutrition supplemented supplemented for 30 days with probiotics (one 0.26 g capsule/day administered via probe) Receives: Dietary Supplement: probiotic supplementation |
| control arm | No intervention | The control group consists of subjects on home enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the gut microbiota composition
To evaluate the impact of 30-days probiotic supplementation on gut microbiota (GM) composition in faecal samples of frail elderly patients receiving home enteral nutrition.
Measured: from the enrolment to the end of study at 30 days
Change in the production of SCFA
To evaluate the impact of a one-month probiotic supplementation on short-chain fatty acid (SCFA) production in faecal samples of frail elderly patients receiving home enteral nutrition.
Measured: from the enrolment to the end of study at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start21 Jun 2018
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Orlandoni, MD, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437352
- Sponsor's protocol ID
- INRCA_002_2026
- Acronym
- MICROBIOTA
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07437352
- Acronym / sponsor ID
- MICROBIOTA / INRCA_002_2026
- Conditions
- Enteral Nutrition
- Keywords
- older people, frailty, gut microbiota, short chain fatty acid, probiotic supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic supplementation arm | Experimental | Dietary Supplement: probiotic supplementationThe experimental arm consists of subjects on home enteral nutrition supplemented supplemented for 30 days with probiotics (one 0.26 g capsule/day administered via probe) |
| control arm | No intervention | –The control group consists of subjects on home enteral nutrition |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Use of oligomeric enteral formula since at least 30-days
- Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic supplementationSubjects take 1 capsule/die of the probiotic SYNBIO® (Synbiotec Srl, Camerino, Italy). Each capsule contains 0.26 g of a 1:1 mixture of Lactobacillus rhamnosus IMC501® and Lactobacillus paracasei IMC502®, equivalent to a daily dose of 15 billion live probiotic cells. For enteral nutrition, the probiotic powder was suspended into 5-10 mL of water and administered directly through the feeding tube. The product is gluten-free, lactose-free, and contains no milk proteins. | Dietary supplement | probiotic supplementation arm |
Primary outcome
Change in the gut microbiota composition
Time frame: from the enrolment to the end of study at 30 days
To evaluate the impact of 30-days probiotic supplementation on gut microbiota (GM) composition in faecal samples of frail elderly patients receiving home enteral nutrition.
Change in the production of SCFA
Time frame: from the enrolment to the end of study at 30 days
To evaluate the impact of a one-month probiotic supplementation on short-chain fatty acid (SCFA) production in faecal samples of frail elderly patients receiving home enteral nutrition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Orlandoni, MD principal investigator
IRCCS INRCA, Ancona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic supplementation in people with Enteral Nutrition, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the gut microbiota composition (time frame: from the enrolment to the end of study at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.