HealthyPhase 1PRIDEC PeruNCT02460575
Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months
A Phase 1 study testing Lactobacillus reuteri 17938 in people with Healthy, run by Tulane University School of Medicine at 1 site in Peru.
Trial summary
Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes. Read more about this study
- Who is it for?
- Ages 2 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus reuteri 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePeru
- Study dates
- 9 Jan 2019to 29 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Have a parental permission form signed by both parents
- Be between 8 weeks to 24 months of age with no preexisting exclusion criteria
- Have parents who are willing to comply with all planned study procedures and be available for planned study visits for 3 months.
Who cannot join
- 1) No enrollment of family members in households where any of the following are present:
- Another study participant in the household
- Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids, methotrexate, etc.) by any household member
- Presence of a serious congenital anomaly or chronic medical condition that in the opinion of the investigators would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
- The following risk factors are at the level of the individual child:
- 2) Allergy to penicillin, cephalosporins, clindamycin or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 30 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
Show all 10Show fewer
- 5) History of diarrheal illness within the past 30 days (See definition in Protocol Appendix B) 6) Presence of fever or a pre-existing adverse event monitored in the study (See Protocol Appendix B Definitions of AEs for specific adverse events monitored in the study) 7) Positive results on serum diagnostic tests for antibodies to HIV.
- 8) Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL
- 9) Out of range laboratory values for total leucocyte count, BUN, Creatinine, AST, ALT, and total bilirubin monitored as potential adverse events, as described in Appendix E.
- 10) Pre-enrollment stool sample (collected within 14 days of day 1 of the study) is positive for L. reuteri by PCR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L. Reuteri for Pediatric Diarrhea in Peru: Growth, Enteropathy, and Microbiota
Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.
Read the detailed description
The study is a single center Phase 1 double blind placebo controlled trial of Lactobacillus reuteri DSM 17938 in children aged 2-24 months. The study population is based in a community with a registered clinical trial center in rural Peru where this protocol can be done in a highly controlled setting. The study is intended to enroll healthy children living in a resource constrained setting where chronic undernutrition and diarrheal disease is common, as this is the population that is most likely to receive benefit from the use of this and or other probiotic products for the treatment of acute infectious diarrhea and environmental enteropathy.
Up to 100 subjects will be enrolled in order to obtain the randomization of 60 subjects, who will receive study product or placebo at a ratio of 2:1. Participants will be enrolled between the ages of 8 weeks and 24 months. There will be no age stratification. Participants will be screened with a baseline history and physical examination and laboratory tests to determine the HIV status of the child, as well baseline laboratory tests to evaluate occult infections, hepatic function, and renal function. Upon randomization subjects will be screened and randomized to a treatment arm. Product will be administered under the direct supervision of study staff daily for 5 days. The primary outcome is the safety and tolerability of the product at this dose and formulation. Safety will be assessed by the monitoring of baseline laboratory tests at 5 and 28 days following the initiation of therapy and by AE monitoring. Tolerability will be evaluated by analyzing 28 day diary cards that are distributed to all randomized subjects on which parents record their child's symptoms (specifically fever, anorexia/oral intake, vomiting, diarrhea, irritability, rash, wheezing, or open fields which allows them to describe any issue their child may experience and grade its severity) . Secondary outcomes include:
- The assessment of the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. This will be determined by and endpoint PCR assay for L. reuteri done on stool collected on D3, D5, D12, D15, D18, D24, D28, D36 on all participants.
The planned enrollment period is four months and the participation of individual subjects is for 3 months. The study should be completed in 7 months. Safety monitoring by treatment group, i.e., infants assigned to active or placebo study product will be conducted by NIDDK appointed DSMB under the direction of the NIDDK Program Official.
- Conditions
- Healthy
- Being tested
- Lactobacillus reuteri 17938, Placebo
- Keywords
- Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri 17938Biological
probiotic
PlaceboBiological
Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus | Experimental | Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. Receives: Biological: Lactobacillus reuteri 17938 |
| Placebo | Placebo comparator | Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Positive Blood Culture for L. Reuteri
number of participants with positive blood culture for L. reuteri
Measured: Participants are followed for an average of 36 days
Mean Daily Temperature
Measured: 5 days of study product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start9 Jan 2019
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia
- Responsible party
- Principal investigator, Richard A. Oberhelman, Tulane University School of Medicine
- Investigators
- Margaret N Kosek, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460575
- Sponsor's protocol ID
- U01DK105849
- Other IDs
- U01DK105849
- Acronym
- PRIDEC Peru
- Status last verified
- Apr 2020
- First submitted
- 28 May 2015
- Last updated
- 4 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L. Reuteri for Pediatric Diarrhea in Peru: Growth, Enteropathy, and Microbiota
- ClinicalTrials.gov ID
- NCT02460575
- Acronym / sponsor ID
- PRIDEC Peru / U01DK105849
- Conditions
- Healthy
- Keywords
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 4 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.
Detailed description
The study is a single center Phase 1 double blind placebo controlled trial of Lactobacillus reuteri DSM 17938 in children aged 2-24 months. The study population is based in a community with a registered clinical trial center in rural Peru where this protocol can be done in a highly controlled setting. The study is intended to enroll healthy children living in a resource constrained setting where chronic undernutrition and diarrheal disease is common, as this is the population that is most likely to receive benefit from the use of this and or other probiotic products for the treatment of acute infectious diarrhea and environmental enteropathy.
Up to 100 subjects will be enrolled in order to obtain the randomization of 60 subjects, who will receive study product or placebo at a ratio of 2:1. Participants will be enrolled between the ages of 8 weeks and 24 months. There will be no age stratification. Participants will be screened with a baseline history and physical examination and laboratory tests to determine the HIV status of the child, as well baseline laboratory tests to evaluate occult infections, hepatic function, and renal function. Upon randomization subjects will be screened and randomized to a treatment arm. Product will be administered under the direct supervision of study staff daily for 5 days. The primary outcome is the safety and tolerability of the product at this dose and formulation. Safety will be assessed by the monitoring of baseline laboratory tests at 5 and 28 days following the initiation of therapy and by AE monitoring. Tolerability will be evaluated by analyzing 28 day diary cards that are distributed to all randomized subjects on which parents record their child's symptoms (specifically fever, anorexia/oral intake, vomiting, diarrhea, irritability, rash, wheezing, or open fields which allows them to describe any issue their child may experience and grade its severity) . Secondary outcomes include:
- The assessment of the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. This will be determined by and endpoint PCR assay for L. reuteri done on stool collected on D3, D5, D12, D15, D18, D24, D28, D36 on all participants.
The planned enrollment period is four months and the participation of individual subjects is for 3 months. The study should be completed in 7 months. Safety monitoring by treatment group, i.e., infants assigned to active or placebo study product will be conducted by NIDDK appointed DSMB under the direction of the NIDDK Program Official.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus | Experimental | Biological: Lactobacillus reuteri 17938Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide. Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops. |
| Placebo | Placebo comparator | Biological: PlaceboComposition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Key exclusion criteria (10 listed)
- 1) No enrollment of family members in households where any of the following are present:
- 2) Allergy to penicillin, cephalosporins, clindamycin or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 30 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
- 5) History of diarrheal illness within the past 30 days (See definition in Protocol Appendix B) 6) Presence of fever or a pre-existing adverse event monitored in the study (See Protocol Appendix B Definitions of AEs for specific adverse events monitored in the study) 7) Positive results on serum diagnostic tests for antibodies to HIV.
- 8) Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL
- 9) Out of range laboratory values for total leucocyte count, BUN, Creatinine, AST, ALT, and total bilirubin monitored as potential adverse events, as described in Appendix E.
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 |
|---|---|---|
| Lactobacillus reuteri 17938probiotic | Biological | Lactobacillus |
| PlaceboComposition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops. | Biological | Placebo |
Primary outcome
Number of Participants With Positive Blood Culture for L. Reuteri
Time frame: Participants are followed for an average of 36 days
number of participants with positive blood culture for L. reuteri
Mean Daily Temperature
Time frame: 5 days of study product administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Margaret N Kosek, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus reuteri 17938 in people with Healthy, run by Tulane University School of Medicine at 1 site in Peru.
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 4 inclusion and 10 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 4 May 2020. 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 Peru. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Positive Blood Culture for L. Reuteri (time frame: Participants are followed for an average of 36 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 4 May 2020.