DiarrheaNCT06403358
Study for Evaluation of Probiotics in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
An observational study of Diarrhea, run by Labomar SPA at 1 site in Italy.
Trial summary
To evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- YOVIS BIMBI
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 28 Nov 2022to 30 Jan 2024
- Phase
- Observational
- 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 3 to 14 years
- All sexes
- Child
Study population: 42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.
Who may be able to join
- • Male and female patients aged between 3 and 14 years;
- Patients with one of the following conditions:
- Population with acute diarrhea;
- Occurrence of at list three liquid or loose stools per day;
- Consistency of stools (≥ type 5) according to Bristol Stool Scale Form (BFS).
- Informed consent signed by parents or the patient's legal guardian(s) for study enrollment.
Who cannot join
- • Presence of chronic diarrhea characterized by the emission of poorly formed stools, for more than 4 weeks, accompanied by increased frequency of evacuation or urgency to defecation;
- Known or potential hypersensitivity and/or history of allergic reactions to one of the components of probiotics food supplement;
- Coexisting severe infection (e.g. sepsis, pneumonia, meningitis);
- Patients affected by chronic intestinal disease, immune deficiency, neurological disease and tumors;
- Contemporary consumption of other probiotics compounds;
- Patients whose parents or the patient's legal guardian(s)refuse to provide written informed consent;
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- Patient who has not expressed his consent according to his age and level of understanding;
- Participation in another clinical trial within the previous 30 days;
- Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise the results
Trial locations and contacts
1 site in 1 country.
Italy1 site
Studio Pediatrico Dr. Gaetano Bottaro
Gravina di Catania, Catania, 95030
About this study
Official title: Prospective Observational Study for the Evaluation of Probiotics Food Supplement in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
To evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea
Read the detailed description
Multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.
- Conditions
- Diarrhea
- Being tested
- YOVIS BIMBI
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOVIS BIMBIDietary supplement
42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
Reduction of the number of loose stools per day
Measured: Baseline, during the intervention, immediately after the intervention
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
Reduction of diarrhea duration.
Measured: Baseline, during the intervention, immediately after the intervention
Secondary outcomes (4)
Evaluation of the safety profile of probiotics food supplement
Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit.
Measured: Immediately after the intervention
Evaluation of the safety profile of probiotics food supplement
Evaluation of the eventual presence adverse event/serious adverse events.
Measured: During the intervention, immediately after the intervention
Assessment of the compliance to the treatment
Compilation of the daily diary to the family;Compilation of the degree satisfaction questionnaires to the family;Compilation of the degree satisfaction questionnaires to the patient
Measured: During the intervention, immediately after the intervention
Analysis of the hydration state
Degree of dehydration using the Gorelick scale: using the 10-point score: 0 to 3 (mild dehydration), 3 to 5 (moderate dehydration), 6 to 10 (severe dehydration); Change in body weight;
Measured: BaselinaDuring the intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start28 Nov 2022
- Primary completion26 May 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labomar SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403358
- Sponsor's protocol ID
- YOV/042022
- Status last verified
- May 2024
- First submitted
- 19 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Evaluation of Probiotics Food Supplement in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
- ClinicalTrials.gov ID
- NCT06403358
- Acronym / sponsor ID
- YOV/042022
- Conditions
- Diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Labomar SPAIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 7 May 2024 (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.
To evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea
Detailed description
Multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- 42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.
Key inclusion criteria (6 listed)
- • Male and female patients aged between 3 and 14 years;
Key exclusion criteria (9 listed)
- • Presence of chronic diarrhea characterized by the emission of poorly formed stools, for more than 4 weeks, accompanied by increased frequency of evacuation or urgency to defecation;
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 |
|---|---|---|
| YOVIS BIMBI42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites. | Dietary supplement | – |
Primary outcome
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
Time frame: Baseline, during the intervention, immediately after the intervention
Reduction of the number of loose stools per day
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea
Time frame: Baseline, during the intervention, immediately after the intervention
Reduction of diarrhea duration.
4 secondary outcomes
Evaluation of the safety profile of probiotics food supplement
Time frame: Immediately after the intervention
Evaluation of the safety profile of probiotics food supplement
Time frame: During the intervention, immediately after the intervention
Assessment of the compliance to the treatment
Time frame: During the intervention, immediately after the intervention
Analysis of the hydration state
Time frame: BaselinaDuring the intervention, immediately after the intervention
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 7 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by Labomar SPA 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 6 inclusion and 9 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 7 May 2024. 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?
Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea (time frame: Baseline, during the intervention, immediately after the intervention). 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 7 May 2024.