HealthyPhase 1NCT00774163

Safety of Lactobacillus Reuteri in Healthy Volunteers

A Phase 1 study testing Lactobacillus reuteri in people with Healthy, run by Tulane University School of Medicine at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of pediatric diarrhea in Peru. Read more about this study

Who is it for?: Ages 18 to 65 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: 45 participants
Where: 1 sitePeru
Study dates: Feb 2010to Oct 2010
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults 18-65 with no exclusion criteria
Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).

Who cannot join

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 (corticosteroids, methotrexate) by any household member
Presence of a serious congenital anomaly or chronic medical condition that 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

Allergy to penicillin or cephalosporins
History of antibiotic use in the last 30 days
Use of probiotic products within the past 90 days
History of diarrheal illness within the past 30 days
Presence of fever or a pre-existing adverse event monitored in the study
Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core antigen, and Hepatitis C.

Trial locations and contacts

1 site in 1 country.

Peru1 site

Community of Santa Clara
Iquitos, Loreto

Other trials in Peru

About this study

Official title: Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers

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).

Conditions: Healthy
Being tested: Lactobacillus reuteri, Placebo
Keywords: probiotics, lactobacillus, reuteri, none (safety only)

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
Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
PlaceboOther
5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period

Study groups in NCT00774163
Study group	Role	What they receive
1	Experimental	Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period Receives: Biological: Lactobacillus reuteri
2	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 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Positive Blood Culture for L. Reuteri
To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).
Measured: participants were followed for an average of 36 days
Mean Daily Temperature
Measured daily during 5 days of study product administration
Measured: 5 days of study product administration
Leukocyte Count on Day 5
Measured: Measured on day 5
Serum Alanine Aminotransferase (ALT) in Female Participants
Measured: Day 5
Serum ALT in Males
Measured: Day 5
Serum Aspartate Aminotransferase (AST) in Females
Measured: Day 5
Serum AST in Males
Measured: Day 5
Blood Urea Nitrogen
Measured: Day 5
Serum Creatinine
Measured: Day 5

Secondary outcomes (8)

Number of Subjects With at Least One PCR Positive Stool Specimen
Measured: Average of 36 day follow up period
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported
Measured: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported
Measured: Day 0 through 6 weeks after Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Oct 2010

First posted17 Oct 2008 (estimated)
Study startFeb 2010
Primary completionJun 2010
Study completionOct 2010

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00774163
Sponsor's protocol ID: FDA IND# 13710
Other IDs: 1R01AT002733-01A1
Status last verified: Dec 2016
First submitted: 15 Oct 2008
Last updated: 19 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1: Safety of Lactobacillus Reuteri in Healthy Volunteers
ClinicalTrials.gov ID: NCT00774163
Acronym / sponsor ID: FDA IND# 13710
Conditions: Healthy
Keywords: probiotics, lactobacillus, reuteri, none (safety only)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 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: Feb 2010
Primary completion: Jun 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 17 Oct 2008 (estimated)
Results: Posted 12 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

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
1	Experimental	Biological: Lactobacillus reuteriLactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
2	Placebo comparator	Other: 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults 18-65 with no exclusion criteria
Subject is a male or, if the subject is female and of childbearing potential then she must have a negative serum or urine pregnancy test result within 48 hours of initiating study preparations and agree to use an acceptable method of contraception. Acceptable methods of contraception include depot forms of progesterone containing therapies or an intrauterine device (IUD).

Key exclusion criteria (12 listed)

No enrollment of family members in households where any of the following are present:
Allergy to penicillin or cephalosporins
History of antibiotic use in the last 30 days
Use of probiotic products within the past 90 days
History of diarrheal illness within the past 30 days

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 DropsLactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period	Biological	1
Placebo5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period	Other	2

Primary outcome

Number of Participants With a Positive Blood Culture for L. Reuteri
Time frame: participants were followed for an average of 36 days
To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).
Mean Daily Temperature
Time frame: 5 days of study product administration
Measured daily during 5 days of study product administration
Leukocyte Count on Day 5
Time frame: Measured on day 5
Serum Alanine Aminotransferase (ALT) in Female Participants
Time frame: Day 5
Serum ALT in Males
Time frame: Day 5
Serum Aspartate Aminotransferase (AST) in Females
Time frame: Day 5
Serum AST in Males
Time frame: Day 5
Blood Urea Nitrogen
Time frame: Day 5
Serum Creatinine
Time frame: Day 5

8 secondary outcomes

Number of Subjects With at Least One PCR Positive Stool Specimen
Time frame: Average of 36 day follow up period
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported
Time frame: Day 0 through 6 weeks after Day 0
Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported
Time frame: Day 0 through 6 weeks after Day 0

Results and safety

Results posted to the registry on 12 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lactobacillus Group	30	30
Placebo Group	15	15

Primary outcome: Number of Participants With a Positive Blood Culture for L. Reuteri

Time frame: participants were followed for an average of 36 days. Number. Unit: participants

Measure	Lactobacillus Reuteri Group n = 30	Placebo Group n = 15
Value	0	0

Population analysed: 2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol

Primary outcome: Mean Daily Temperature

Time frame: 5 days of study product administration. Mean (Standard Deviation). Unit: Degrees Celcius

Measure	Lactobacillus Reuteri Group n = 30	Placebo Group n = 15
Value	36.02 (0.5)	36.04 (0.5)

Primary outcome: Leukocyte Count on Day 5

Time frame: Measured on day 5. Mean (Standard Deviation). Unit: cells per cubic millimeter

Measure	Lactobacillus Reuteri Group n = 30	Placebo Group n = 15
Value	6936 (1331)	7893 (1168)

Primary outcome: Serum Alanine Aminotransferase (ALT) in Female Participants

Time frame: Day 5. Mean (Standard Deviation). Unit: units per liter (U/L)

Measure	Lactobacillus Reuteri Group n = 23	Placebo Group n = 9
Value	30.3 (18.0)	22.2 (12.4)

Population analysed: limited to females

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months from initiation of study. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lactobacillus Reuteri Group	0 of 30 (0%)	27 of 30 (90%)	Not reported
Placebo Group	0 of 15 (0%)	13 of 15 (86.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
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.

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 2 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 19 Dec 2016. 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 12 Jul 2013). 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 a Positive Blood Culture for L. Reuteri (time frame: participants were followed for an average of 36 days). The study lists 9 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 NCT00774163.

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 19 Dec 2016.