HealthyPhase 1NCT01899378
Safety and Efficacy of Probiotics in Bangladeshi Infants
A Phase 1 study testing Lactobacillus reuteri DSM 17938 and Bifidobacterium longum infantis in people with Healthy, run by Stanford University at 1 site in Bangladesh.
Trial summary
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus reuteri DSM 17938 and Bifidobacterium longum infantis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBangladesh
- Study dates
- Oct 2013to Jul 2014
- Phase
- Phase 1
- 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 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants.
- Infants 1 -3 months of age at the beginning of the study.
- Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
- Parents and child are planning to remain in Dhaka for the next four months.
Who cannot join
- Infants with known birth defects.
- Infants who have been hospitalized.
- Infants who have an acute infection or illness at the time of enrolment.
- Infants who are currently taking antibiotics
- Infants <1 month of age or >3 months of age.
- Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
Show all 10Show fewer
- Infants who are already receiving a probiotic product or treatment.
- A diagnosis or suspicion of immunodeficiency disorder.
- A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
- Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Center for Diarrheal Disease Research, Bangladesh
Dhaka
About this study
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
- Conditions
- Healthy
- Being tested
- Lactobacillus reuteri DSM 17938, Bifidobacterium longum infantis
- Keywords
- probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
Also called BioGaia Protectis Baby
10^8 CFU
Bifidobacterium longum infantisDietary supplement
Also called Align
10^9 CFU
| Study group | Role | What they receive |
|---|---|---|
| daily probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Bifidobacterium longum infantis |
| weekly probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Bifidobacterium longum infantis |
| bi-weekly probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Bifidobacterium longum infantis |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of probiotic in the stool
presence of absence of each probiotic in the stool
Measured: weeks 0-12
Adverse events
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
Measured: duration of study - through study completion
Secondary outcomes (8)
quantity of probiotic in the stool
amount of each probiotic present in the stool
Measured: weeks 0-12
composition of microbiota
microbial community composition
Measured: weeks 0-12
clinical effects
fever, diarrhea, wheezing, rash, stool frequency, feeding frequency
Measured: daily for 7 days after first probiotic administration, then weeks 2-12
gut function
lactulose/mannitol ratio
Measured: months 0, 1, 2, 3
gut inflammation
fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth
Measured: months 0,1,2,3
gut inflammation/translocation
IL22, CD-14, total IgG and c-reactive protein
Measured: months 0, 1, 2, 3
growth
weight, length, head circumference
Measured: month 0, 1, 2, 3
breastfeeding rates
Measured: month 0, 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
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 HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Thrasher Research Fund
- Responsible party
- Principal investigator, Julie Parsonnet, Stanford University
- Investigators
- Yana Emmy E Hoy-Schulz, PhD, Study director, Stanford UniversityJulie Parsonnet, MD, Principal investigator, Stanford UniversityStephen Luby, MD, Principal investigator, Stanford UniversityLeanne Unicomb, PhD, Principal investigator, International Center for Diarrheal Disease Research, BangladeshKaniz Jannat, MBBS, Study director, International Center for Diarrheal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899378
- Sponsor's protocol ID
- SPO109949
- Status last verified
- Apr 2016
- First submitted
- 10 Jul 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roberts TJ, Hoy-Schulz YE, Jannat K, Parsonnet J. Evidence of inflated exclusive breastfeeding estimates from a clinical trial in Bangladesh. Int Breastfeed J. 2018 Aug 22;13:39. doi: 10.1186/s13006-018-0179-4. eCollection 2018.
PubMed 30159001Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
PubMed 26832746
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Probiotics in Bangladeshi Infants
- ClinicalTrials.gov ID
- NCT01899378
- Acronym / sponsor ID
- SPO109949
- Conditions
- Healthy
- Keywords
- probiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Thrasher Research Fund
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jul 2013 (estimated)
- 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.
Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| daily probiotic | Experimental | Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month |
| weekly probiotic | Experimental | Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month |
| bi-weekly probiotic | Experimental | Dietary Supplement: Lactobacillus reuteri DSM 17938, Dietary Supplement: Bifidobacterium longum infantis10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month |
| control | No intervention | – |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants.
- Infants 1 -3 months of age at the beginning of the study.
- Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
- Parents and child are planning to remain in Dhaka for the next four months.
Key exclusion criteria (10 listed)
- Infants with known birth defects.
- Infants who have been hospitalized.
- Infants who have an acute infection or illness at the time of enrolment.
- Infants who are currently taking antibiotics
- Infants <1 month of age or >3 months of age.
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 DSM 17938Also: BioGaia Protectis Baby10^8 CFU | Dietary supplement | bi-weekly probiotic, daily probiotic, weekly probiotic |
| Bifidobacterium longum infantisAlso: Align10^9 CFU | Dietary supplement | bi-weekly probiotic, daily probiotic, weekly probiotic |
Primary outcome
Presence of probiotic in the stool
Time frame: weeks 0-12
presence of absence of each probiotic in the stool
Adverse events
Time frame: duration of study - through study completion
Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms
8 secondary outcomes
quantity of probiotic in the stool
Time frame: weeks 0-12
composition of microbiota
Time frame: weeks 0-12
clinical effects
Time frame: daily for 7 days after first probiotic administration, then weeks 2-12
gut function
Time frame: months 0, 1, 2, 3
gut inflammation
Time frame: months 0,1,2,3
gut inflammation/translocation
Time frame: months 0, 1, 2, 3
growth
Time frame: month 0, 1, 2, 3
breastfeeding rates
Time frame: month 0, 1, 2, 3
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 17 Oct 2016.
- Derived from this study: PubMed 30159001Roberts TJ, Hoy-Schulz YE, Jannat K, Parsonnet J. Evidence of inflated exclusive breastfeeding estimates from a clinical trial in Bangladesh. Int Breastfeed J. 2018 Aug 22;13:39. doi: 10.1186/s13006-018-0179-4. eCollection 2018.
- Derived from this study: PubMed 26832746Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1.
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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.
Yana Emmy E Hoy-Schulz, PhD study director
Stanford University
Julie Parsonnet, MD principal investigator
Stanford University
Stephen Luby, MD principal investigator
Stanford University
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 DSM 17938 and Bifidobacterium longum infantis in people with Healthy, run by Stanford University at 1 site in Bangladesh.
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 17 Oct 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 Bangladesh. 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.
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?
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?
Presence of probiotic in the stool (time frame: weeks 0-12). 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 NCT01899378, 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 17 Oct 2016.