Premature InfantPREBIOMANCT03701906
Effect of a Mixture of New Probiotic Strains in Preterm Infants
A study testing Lactobacillus PS11603 & Bifidobacterium PS10402 in people with Premature Infant, run by ProbiSearch SL at 1 site in Spain.
Trial summary
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation. Read more about this study
- Who is it for?
- Ages 1 minute to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- What is being tested?
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2018to 31 Dec 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 1 minute to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.
- Written informed consent signed by the parent or legal guardian.
- Tolerate enteral feeding, at least 10mL / kg / day.
- Postnatal age ≤ 5 days
Who cannot join
- Child with malformations
- With short bowel syndrome or any surgery in the gastrointestinal tract
- With defect in the intestinal epithelial barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Read the detailed description
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
- Conditions
- Premature Infant
- Being tested
- Lactobacillus PS11603 & Bifidobacterium PS10402, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus PS11603 & Bifidobacterium PS10402Dietary supplement
Also called Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeks
Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1*10E9 CFU of L.salivarius PS11603 and 1*10E8 CFU of B.longum PS10402.
PlaceboDietary supplement
8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus PS11603 & Bifidobacterium PS10402 | Active comparator | A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. Receives: Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402 |
| Placebo | Active comparator | 1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start22 Oct 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susana Manzano, PhD, Study chair, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701906
- Sponsor's protocol ID
- PRE/18.02
- Acronym
- PREBIOMA
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25.
PubMed 35221319
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
- ClinicalTrials.gov ID
- NCT03701906
- Acronym / sponsor ID
- PREBIOMA / PRE/18.02
- Conditions
- Premature Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Oct 2018 (actual)
- 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.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Detailed description
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 \& Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation.
The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus PS11603 & Bifidobacterium PS10402 | Active comparator | Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus PS11603 and 1*10E8 CFU of Bifidobacterium PS10402 in 1 vial will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. |
| Placebo | Active comparator | Dietary Supplement: Placebo1 vial of Placebo will be dissolved and enterally administered daily until discharge from the Neonatal Unit or until the 36th post-gestational week of age. |
Who may qualify
- Ages
- 1 minute to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation.
- Written informed consent signed by the parent or legal guardian.
- Tolerate enteral feeding, at least 10mL / kg / day.
- Postnatal age ≤ 5 days
Key exclusion criteria (3 listed)
- Child with malformations
- With short bowel syndrome or any surgery in the gastrointestinal tract
- With defect in the intestinal epithelial barrier
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 PS11603 & Bifidobacterium PS10402Also: Lactobacillus PS11603 & Bifidobacterium PS10402 during 8 weeksApproximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1*10E9 CFU of L.salivarius PS11603 and 1*10E8 CFU of B.longum PS10402. | Dietary supplement | Lactobacillus PS11603 & Bifidobacterium PS10402 |
| Placebo8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement. | Dietary supplement | Placebo |
Primary outcome
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples.
Time frame: 2 months
Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants
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 22 Oct 2020.
- Derived from this study: PubMed 35221319Moreno-Sanz B, Montes MT, Manzano S, Espinosa-Martos I, Cardenas N, Esteban S, Cruz M, Jimenez E, de Pipaon MS. Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Two Probiotics on the Preterms' Gut Microbiota. J Pediatr Gastroenterol Nutr. 2022 Jun 1;74(6):e153-e159. doi: 10.1097/MPG.0000000000003427. Epub 2022 Feb 25.
- 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.
Susana Manzano, PhD study chair
ProbiSearch SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus PS11603 & Bifidobacterium PS10402 in people with Premature Infant, run by ProbiSearch SL at 1 site in Spain.
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 3 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 22 Oct 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 Spain. 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.
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?
Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. (time frame: 2 months). 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 NCT03701906, 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 22 Oct 2020.