DiarrheaNCT01992497
Cesarean Section Study
A study testing Probiotic in people with Diarrhea and Atopic Dermatitis, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Atopic Dermatitis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 721 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to 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 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
- healthy newborns
- born by Cesarean section
- singleton birth
- Age at enrollment in the study < 24h
- birth weight ≥ 2500g and ≤ 4300g
- gestational age ≥ 37 weeks and ≤ 42 weeks
Who cannot join
- congenital diseases or malformations that may inhibit growth
- prenatal and/or postnatal diseases
- parents are expected to have difficulty complying with the feeding regime
- planned re-admittance to the hospital in the first 14 days of life
- antibiotic treatment at the time of enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.
- Conditions
- Diarrhea, Atopic Dermatitis
- Being tested
- Probiotic
- Keywords
- Cesarean section, probiotic, formula fed, gut microbiota
- Medical subject headings
- Diarrhea, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Formula + placebo | Placebo comparator | Not described Receives: Dietary Supplement: Probiotic |
| Formula + probiotic | Experimental | Formula + probiotic Receives: Dietary Supplement: Probiotic |
| Breastfed + probiotic | Experimental | Breastfed + probiotic Receives: Dietary Supplement: Probiotic |
| Breastfed + placebo | Placebo comparator | Not described Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diarrhea episodes between a probiotic vs. placebo
Measured: 12 months
Secondary outcomes (1)
Diarrhea duration between a probiotic vs. placebo
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992497
- Sponsor's protocol ID
- 12.14.INF
- Status last verified
- Apr 2020
- First submitted
- 19 Nov 2013
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study
- ClinicalTrials.gov ID
- NCT01992497
- Acronym / sponsor ID
- 12.14.INF
- Conditions
- Diarrhea, Atopic Dermatitis
- Keywords
- Cesarean section, probiotic, formula fed, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Nov 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.
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Formula + placebo | Placebo comparator | Dietary Supplement: Probiotic |
| Formula + probiotic | Experimental | Dietary Supplement: ProbioticFormula + probiotic |
| Breastfed + probiotic | Experimental | Dietary Supplement: ProbioticBreastfed + probiotic |
| Breastfed + placebo | Placebo comparator | Dietary Supplement: Probiotic |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
- healthy newborns
- born by Cesarean section
- singleton birth
- Age at enrollment in the study < 24h
Key exclusion criteria (5 listed)
- congenital diseases or malformations that may inhibit growth
- prenatal and/or postnatal diseases
- parents are expected to have difficulty complying with the feeding regime
- planned re-admittance to the hospital in the first 14 days of life
- antibiotic treatment at the time of enrollment in the study
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 |
|---|---|---|
| Probiotic | Dietary supplement | Breastfed + placebo, Breastfed + probiotic, Formula + placebo, Formula + probiotic |
Primary outcome
Number of diarrhea episodes between a probiotic vs. placebo
Time frame: 12 months
1 secondary outcome
Diarrhea duration between a probiotic vs. placebo
Time frame: 12 months
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 24 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Diarrhea and Atopic Dermatitis, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 7 inclusion and 5 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 24 Apr 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 Germany. 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?
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?
Number of diarrhea episodes between a probiotic vs. placebo (time frame: 12 months). 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 24 Apr 2020.