HealthyPhase 1NCT02124122
Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
A Phase 1 study testing Lactobacillus reuteri in people with Healthy, run by Tulane University School of Medicine at 1 site in Peru.
Trial summary
This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePeru
- Study dates
- Mar 2015to Jan 2016
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children ages 2-5 years with no exclusion criteria
Who cannot join
- 1) No enrollment of family members in households where any of the following are present:
- Another study participant in the household
- Pregnancy or current breastfeeding by any household member
- Presence of an infant under age 6 months living in the household
- Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids and 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
Show all 12Show fewer
- 2) Allergy to penicillin or cephalosporins or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 90 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 6) Presence of fever or a pre-existing adverse event monitored in the study 7) Positive results on serum diagnostic tests for antibodies to HIV.
- Testing for Hepatitis B core antigen, and Hepatitis C is not necessary in children as in adults, since there is universal vaccination for Hepatitis B among children in this community, and both forms of hepatitis are rare and largely asymptomatic in this age group.
- 8) Presence of severe anemia, defined as serum hemoglobin < 8 gm/dL
- 9) Out of range laboratory values for tests monitored as potential adverse events, as described in Appendix 2, B. LABORATORY VALUES, and detected based on Day 0 blood test results. However, subjects will only be excluded based on serum hemoglobin if they meet exclusion criterion 8.
- 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
This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.
Read the detailed description
This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:
- Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
- Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
In the first 30 subjects randomized, administration of each dose of the study preparation drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled will not be offered PediaSure ® after product administration. This format will also allow us to assess the impact of concurrent administration of a buffering non-lactose containing formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by PCR.
- Conditions
- Healthy
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- Focus, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriBiological
Also called BioGaia Probiotic Drops
Probiotic
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus | Experimental | Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730). Receives: Biological: Lactobacillus reuteri |
| Placebo | Placebo comparator | Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden). 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
Measured: Participants are followed an average of 36 days
Mean Daily Temperature
Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
Measured: Study days 1-5, 8,12, 15, 18, 28, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionJan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Johns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma
- Responsible party
- Principal investigator, Richard A. Oberhelman, Tulane University School of Medicine
- Investigators
- Richard A Oberhelman, MD, Principal investigator, Tulane School of Public Health and Tropical MedicineMargaret N Kosek, MD, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124122
- Sponsor's protocol ID
- FDA IND# 13710-Protocol 2
- Other IDs
- 5U01AT002733
- Status last verified
- Mar 2017
- First submitted
- 24 Apr 2014
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kosek MN, Penataro-Yori P, Paredes-Olortegui M, Lefante J, Ramal-Asayag C, Zamora-Babilonia M, Meza-Sanchez G, Oberhelman RA. Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. Pediatr Infect Dis J. 2019 Aug;38(8):e178-e180. doi: 10.1097/INF.0000000000002267.
PubMed 30531312
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
- ClinicalTrials.gov ID
- NCT02124122
- Acronym / sponsor ID
- FDA IND# 13710-Protocol 2
- Conditions
- Healthy
- Keywords
- Focus, 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
- National Center for Complementary and Integrative Health (NCCIH), Johns Hopkins Bloomberg School of Public Health, Asociacion Benefica Prisma
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.
Detailed description
This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1. Subjects will be randomized to receive either:
- Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).
- Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).
In the first 30 subjects randomized, administration of each dose of the study preparation drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled will not be offered PediaSure ® after product administration. This format will also allow us to assess the impact of concurrent administration of a buffering non-lactose containing formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by PCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus | Experimental | Biological: Lactobacillus reuteriLactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730). |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden). |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 2-5 years with no exclusion criteria
Key exclusion criteria (12 listed)
- 1) No enrollment of family members in households where any of the following are present:
- 2) Allergy to penicillin or cephalosporins or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 90 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 6) Presence of fever or a pre-existing adverse event monitored in the study 7) Positive results on serum diagnostic tests for antibodies to HIV.
- Testing for Hepatitis B core antigen, and Hepatitis C is not necessary in children as in adults, since there is universal vaccination for Hepatitis B among children in this community, and both forms of hepatitis are rare and largely asymptomatic in this age group.
- 8) Presence of severe anemia, defined as serum hemoglobin < 8 gm/dL
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 reuteriAlso: BioGaia Probiotic DropsProbiotic | Biological | Lactobacillus |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Number of Participants With Positive Blood Culture for L Reuteri
Time frame: Participants are followed an average of 36 days
Mean Daily Temperature
Time frame: Study days 1-5, 8,12, 15, 18, 28, and 36
Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30531312Kosek MN, Penataro-Yori P, Paredes-Olortegui M, Lefante J, Ramal-Asayag C, Zamora-Babilonia M, Meza-Sanchez G, Oberhelman RA. Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. Pediatr Infect Dis J. 2019 Aug;38(8):e178-e180. doi: 10.1097/INF.0000000000002267.
- Individual participant dataSharing planned: Undecided
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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.
Richard A Oberhelman, MD principal investigator
Tulane School of Public Health and Tropical Medicine
Margaret N Kosek, MD study director
Johns Hopkins Bloomberg School of Public Health
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 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 1 inclusion and 12 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 24 Apr 2017. 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 24 Apr 2017). 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 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?
On the ClinicalTrials.gov record for NCT02124122, which also lists 1 linked publication.
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 24 Apr 2017.