DiarrheaPhase 2NCT06125626
Prevention of Traveler's Diarrhea
A Phase 2 study testing Probiotical in people with Diarrhea, run by University of Palermo at 1 site in Italy.
Trial summary
The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Probiotical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2023to 10 Oct 2023
- Phase
- Phase 2
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy bikers
- Able to pass the Amazonia forest by bike
Who cannot join
- None predifinied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Traveler's Diarrhea While Crossing the Amazon Forest by Bike With a Supplement Based on Lacticaseibacillus Rhamnosus LR04 + Streptococcus Thermophilus FP4 + Bifidobacterium Brevis BR03: a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study
The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.
- Conditions
- Diarrhea
- Being tested
- Probiotical, Placebo
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticalDietary supplement
A daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 will be given to this group
PlaceboOther
A daily sachet of placebo will be given to this groups
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | This arm will receive a daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 Receives: Dietary Supplement: Probiotical |
| Placebo | Placebo comparator | This arm will receive a dose of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diarrhea
Diarrhea will be defined using the Bristol's scale (value of 7) in a scale between 1 and 7, higher values reflecting more diarrhoic attitude
Measured: 12 weeks
Secondary outcomes (2)
Mean quality of life
Quality of life will be assessed using the short-form 12 (SF-12) with a standardized score between 0 and 100% compared to the Italian population.
Measured: 12 weeks
Incidence of severe diarrhea
Severe diarrhea will be defined as a diarrhea requiring hospitalization or intravenous hydratation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Jul 2023
- Primary completion7 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Veronese, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125626
- Sponsor's protocol ID
- 153/2023
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Briand V, Buffet P, Genty S, Lacombe K, Godineau N, Salomon J, Vandemelbrouck E, Ralaimazava P, Goujon C, Matheron S, Fontanet A, Bouchaud O. Absence of efficacy of nonviable Lactobacillus acidophilus for the prevention of traveler's diarrhea: a randomized, double-blind, controlled study. Clin Infect Dis. 2006 Nov 1;43(9):1170-5. doi: 10.1086/508178. Epub 2006 Sep 27.
PubMed 17029137Hilton E, Kolakowski P, Singer C, Smith M. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. J Travel Med. 1997 Mar 1;4(1):41-43. doi: 10.1111/j.1708-8305.1997.tb00772.x.
PubMed 9815476
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Traveler's Diarrhea While Crossing the Amazon Forest by Bike With a Supplement Based on Lacticaseibacillus Rhamnosus LR04 + Streptococcus Thermophilus FP4 + Bifidobacterium Brevis BR03: a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT06125626
- Acronym / sponsor ID
- 153/2023
- Conditions
- Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 9 Nov 2023 (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.
The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticalThis arm will receive a daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 |
| Placebo | Placebo comparator | Other: PlaceboThis arm will receive a dose of placebo |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy bikers
- Able to pass the Amazonia forest by bike
Key exclusion criteria (1 listed)
- None predifinied
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 |
|---|---|---|
| ProbioticalA daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 will be given to this group | Dietary supplement | Probiotics |
| PlaceboA daily sachet of placebo will be given to this groups | Other | Placebo |
Primary outcome
Incidence of diarrhea
Time frame: 12 weeks
Diarrhea will be defined using the Bristol's scale (value of 7) in a scale between 1 and 7, higher values reflecting more diarrhoic attitude
2 secondary outcomes
Mean quality of life
Time frame: 12 weeks
Incidence of severe diarrhea
Time frame: 12 weeks
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 13 Nov 2023.
- Background: PubMed 17029137Briand V, Buffet P, Genty S, Lacombe K, Godineau N, Salomon J, Vandemelbrouck E, Ralaimazava P, Goujon C, Matheron S, Fontanet A, Bouchaud O. Absence of efficacy of nonviable Lactobacillus acidophilus for the prevention of traveler's diarrhea: a randomized, double-blind, controlled study. Clin Infect Dis. 2006 Nov 1;43(9):1170-5. doi: 10.1086/508178. Epub 2006 Sep 27.
- Background: PubMed 9815476Hilton E, Kolakowski P, Singer C, Smith M. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. J Travel Med. 1997 Mar 1;4(1):41-43. doi: 10.1111/j.1708-8305.1997.tb00772.x.
- Individual participant dataSharing planned: Yes
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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?
A Phase 2 study testing Probiotical in people with Diarrhea, run by University of Palermo 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 1 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 13 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of diarrhea (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125626, which also lists 2 linked publications.
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 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.