Gut MicrobiotaNCT04994834
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics
A study testing Probiotics in people with Gut Microbiota, run by Chr Hansen at 1 site in Denmark.
Trial summary
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces. Read more about this study
- Who is it for?
- Ages 0 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2021to 1 Jun 2022
- 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 0 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks
- Birthweight more than 2500 g
- No exposure to oral or intravenous antibiotics
- No complications that need medical interventions (e.g. respiratory distress symptoms or infections)
- Both legal guardians provided voluntary written informed consent on behalf of the infant
- Pregnant women:
Show all 13Show fewer
- Women age above 18 years at informed consent
- Singleton pregnancy
- Uncomplicated pregnancy
- No use of medication
- Aim to give birth vaginally and breastfeed
- No use of probiotics during the last month before estimated birth and until six weeks postpartum
- Provided voluntary written informed consent
Who cannot join
- Admission to the neonatal intensive care unit (NICU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
Read the detailed description
The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.
During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.
Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.
- Conditions
- Gut Microbiota
- Being tested
- Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Probiotics Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of the investigational product in the infant feces
Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR
Measured: 28 days after birth
Secondary outcomes (3)
Total fecal Bifidobacterium in infant fecal samples
Total fecal Bifidobacterium in infant fecal samples after 4 weeks supplementation Quantification of total Bifidobacterium will be determined by PCR.
Measured: Baseline, Day14, Day 28
Characterization of the infant intestinal microbiota after 4 weeks supplementation
Characterization of the infant intestinal microbiota after 4 weeks supplementation of the investigational product using sequencing
Measured: Baseline, Day 14, Day 28
Adverse events (Safety)
Frequency and severity of adverse events
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Jul 2021
- Primary completion30 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Henning Pedersen, Professor, Principal investigator, Department of Gynecology and Obstetrics, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994834
- Sponsor's protocol ID
- HND-IN-037
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To share IPD not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics - an Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT04994834
- Acronym / sponsor ID
- HND-IN-037
- Conditions
- Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Aug 2021 (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.
A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.
Detailed description
The four weeks intervention starts within 24 hours after birth of the study subject and the investigational product will be given for 28 days, followed by a two weeks follow-up period without any intake of the investigational product.
During the entire study period, five visits are scheduled. Visit 2 to Visit 5 are home visits by the study midwife. From Visit 2 and throughout the study period (Visit 2 to Visit 5) the parents will be asked to complete a diary daily.
Infant stool samples will be collected on multiple occasions during the study, as well as maternal breast milk samples, stool and urine samples and samples from vagina. In addition, sample from placenta, umbilical cord, umbilical cord blood and amnion fluid will be collected. Mothers will be asked to complete electronic questionnaires daily during the course of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: ProbioticsProbiotics |
Who may qualify
- Ages
- 0 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Gestational age at birth ≥ 37±0 ≤ weeks 42±0 weeks
- Birthweight more than 2500 g
- No exposure to oral or intravenous antibiotics
- No complications that need medical interventions (e.g. respiratory distress symptoms or infections)
- Both legal guardians provided voluntary written informed consent on behalf of the infant
Key exclusion criteria (1 listed)
- Admission to the neonatal intensive care unit (NICU)
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 |
|---|---|---|
| ProbioticsOnce a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth | Dietary supplement | Intervention |
Primary outcome
Recovery of the investigational product in the infant feces
Time frame: 28 days after birth
Presence of the investigational product in infant fecal samples after 4 weeks of supplementation (Visit 4) using PCR
3 secondary outcomes
Total fecal Bifidobacterium in infant fecal samples
Time frame: Baseline, Day14, Day 28
Characterization of the infant intestinal microbiota after 4 weeks supplementation
Time frame: Baseline, Day 14, Day 28
Adverse events (Safety)
Time frame: up to 6 weeks
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 12 Jul 2022.
- Individual participant dataSharing planned: No. To share IPD not decided yet
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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.
Lars Henning Pedersen, Professor principal investigator
Department of Gynecology and Obstetrics, Aarhus 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 Probiotics in people with Gut Microbiota, run by Chr Hansen at 1 site in Denmark.
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 13 inclusion and 1 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 12 Jul 2022. 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 Denmark. 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?
Recovery of the investigational product in the infant feces (time frame: 28 days after birth). 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 12 Jul 2022.