Premature; Infant, Light-for-datesProPreNCT01454661
Probiotics and Early Microbial Contact in Preterm Neonates
A study testing LGG and LGG+Bb-12 in people with Premature; Infant, Light-for-dates and Breastfeeding, run by Turku University Hospital at 1 site in Finland.
Trial summary
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Premature; Infant, Light-for-dates, Breastfeeding
- What is being tested?
- LGG and LGG+Bb-12
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2014to Apr 2019
- Phase
- Interventional
- 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- premature infant born at <35 weeks gestational age
Who cannot join
- severe asphyxia
- significant anomalies
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20520
Samuli Rautava, MD, PhD, +358 40 7033166, samrau@utu.fi
About this study
Official title: Probiotic Modulation of Early Microbial Contact in Premature Infants
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.
This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.
Read more
The specific aims of the project are:
- To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.
- To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.
- To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.
- Conditions
- Premature; Infant, Light-for-dates, Breastfeeding
- Being tested
- LGG, LGG+Bb-12, Placebo
- Keywords
- Probiotics, Premature infant, Intestinal microbiota, Intestinal immunity, Breastfeeding
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGGDietary supplement
Lactobacillus rhamnosus GG 10E9 cfu / day
LGG+Bb-12Dietary supplement
A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.
PlaceboDietary supplement
Microcrystalline cellulose is used as placebo.
| Study group | Role | What they receive |
|---|---|---|
| placebo mother - LGG infant | Active comparator | Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG. Receives: Dietary Supplement: LGG |
| placebo mother - placebo infant | Placebo comparator | Placebo is administered to both the lactating mother and her infant. Receives: Dietary Supplement: Placebo |
| LGG mother - placebo infant | Active comparator | The probiotic LGG is administered to the lactating mother whilst the infant receives placebo. Receives: Dietary Supplement: LGG |
| LGG+Bb-12 mother - Placebo infant | Active comparator | A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo. Receives: Dietary Supplement: LGG+Bb-12 |
| Pacebo mother - LGG+Bb-12 infant | Active comparator | Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12 Receives: Dietary Supplement: LGG+Bb-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life
Measured: 1 month
Secondary outcomes (2)
Intestinal immunity
Intestinal immune gene expression profiles will be assessed from fecal samples.
Measured: 1 month
Breast milk compostion
Immunological and microbiological properties of breast milk will be investigated.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startApr 2014
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku, Massachusetts General Hospital
- Responsible party
- Principal investigator, Samuli Rautava, Turku University Hospital
- Investigators
- Samuli Rautava, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454661
- Sponsor's protocol ID
- ETMK 104/180/2011
- Acronym
- ProPre
- Status last verified
- Apr 2018
- First submitted
- 10 Oct 2011
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Modulation of Early Microbial Contact in Premature Infants
- ClinicalTrials.gov ID
- NCT01454661
- Acronym / sponsor ID
- ProPre / ETMK 104/180/2011
- Conditions
- Premature; Infant, Light-for-dates, Breastfeeding
- Keywords
- Probiotics, Premature infant, Intestinal microbiota, Intestinal immunity, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku, Massachusetts General Hospital
- Study start
- Apr 2014
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 19 Oct 2011 (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.
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.
This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.
The specific aims of the project are:
- To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.
- To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.
- To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo mother - LGG infant | Active comparator | Dietary Supplement: LGGPlacebo is administered to the lactating mother whilst the infant receives the probiotic LGG. |
| placebo mother - placebo infant | Placebo comparator | Dietary Supplement: PlaceboPlacebo is administered to both the lactating mother and her infant. |
| LGG mother - placebo infant | Active comparator | Dietary Supplement: LGGThe probiotic LGG is administered to the lactating mother whilst the infant receives placebo. |
| LGG+Bb-12 mother - Placebo infant | Active comparator | Dietary Supplement: LGG+Bb-12A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo. |
| Pacebo mother - LGG+Bb-12 infant | Active comparator | Dietary Supplement: LGG+Bb-12Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12 |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature infant born at <35 weeks gestational age
Key exclusion criteria (2 listed)
- severe asphyxia
- significant anomalies
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 |
|---|---|---|
| LGGLactobacillus rhamnosus GG 10E9 cfu / day | Dietary supplement | LGG mother - placebo infant, placebo mother - LGG infant |
| LGG+Bb-12A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each. | Dietary supplement | LGG+Bb-12 mother - Placebo infant, Pacebo mother - LGG+Bb-12 infant |
| PlaceboMicrocrystalline cellulose is used as placebo. | Dietary supplement | placebo mother - placebo infant |
Primary outcome
Gut microbiota
Time frame: 1 month
Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life
2 secondary outcomes
Intestinal immunity
Time frame: 1 month
Breast milk compostion
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
Related trials for Premature; Infant, Light-for-dates
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
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.
Samuli Rautava, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGG and LGG+Bb-12 in people with Premature; Infant, Light-for-dates and Breastfeeding, run by Turku University Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2018. 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 Finland. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuli Rautava, MD, PhD (+358 40 7033166, samrau@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: 1 month). 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 19 Apr 2018.