InfectionsNCT01603719
Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics
A study testing new infant formula with prebiotics and beta-palmitate in people with Infections and Stool Flora, run by Waldkrankenhaus Protestant Hospital, Spandau at 1 site in Germany.
Trial summary
The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate. Read more about this study
- Who is it for?
- Ages Up to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Infections, Stool Flora, Stool Biochemistry
- What is being tested?
- new infant formula with prebiotics and beta-palmitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jan 2020
- 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 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term neonates
- gestational age 37 to 42 weeks
- birth weight 10th to 90th percentile (Voigt reference)
- infants being exclusively formula-fed at enrollment
Who cannot join
- infants with high risk of atopic disease due to family history
- congenital disorder or syndrome with need for special diet / impairment of growth
- antibiotic medication prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life
The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.
Read the detailed description
An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial.
The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.
- Conditions
- Infections, Stool Flora, Stool Biochemistry, Constipation, Food Intolerance
- Being tested
- new infant formula with prebiotics and beta-palmitate
- Keywords
- infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic
- Medical subject headings
- Infections, Constipation, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new infant formula with prebiotics and beta-palmitateDietary supplement
experimental infant formula as sole source of nutrition over first 12 weeks of life
| Study group | Role | What they receive |
|---|---|---|
| Standard Formula | No intervention | Standard formula with no supplementation |
| experimental formula | Experimental | infant formula with higher beta-palmitate and supplemented GOS Receives: Dietary Supplement: new infant formula with prebiotics and beta-palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of gastrointestinal infections
Measured: within first year of life
Secondary outcomes (8)
proportion of bifidobacteria on total stool bacteria
Measured: after 6 and 12 weeks intervention
number of infectious episodes (gastrointestinal, respiratory, fever episodes)
Measured: within first year of life
anthropometric parameters (gain in weight, length, head circumference)
Measured: after 6 weeks, after 12 weeks intervention
symptoms of food intolerance, constipation, colics
number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation
Measured: after 6 weeks, 12 weeks intervention
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
Measured: after 6 weeks, 12 weeks intervention
atopic manifestation
incidence atopic dermatitis
Measured: within 1st year of life
erythrocytes´ fatty acid profile
palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)
Measured: after 6 weeks intervention
calcium absorption
urinary calcium-creatinin ratio, serum alkaline phosphatase
Measured: after 6 weeks, 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2014
- Study completionJan 2020
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 InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldkrankenhaus Protestant Hospital, Spandau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Nomayo, MD, Waldkrankenhaus Protestant Hospital, Spandau
- Investigators
- Frank Jochum, MD, Principal investigator, Waldkrankenhaus Protestant Hospital, Spandau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603719
- Sponsor's protocol ID
- EWK-001
- Status last verified
- Jun 2020
- First submitted
- 15 May 2012
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lambidou M, Alteheld B, Fimmers R, Jochum F, Nomayo A, Stehle P. Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns. Ann Nutr Metab. 2021;77(3):138-145. doi: 10.1159/000515705. Epub 2021 Apr 30.
PubMed 33934094Nomayo A, Schwiertz A, Rossi R, Timme K, Foster J, Zelenka R, Tvrdik J, Jochum F. Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial. Mol Cell Pediatr. 2020 Jul 2;7(1):6. doi: 10.1186/s40348-020-00098-1.
PubMed 32613402
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life
- ClinicalTrials.gov ID
- NCT01603719
- Acronym / sponsor ID
- EWK-001
- Conditions
- Infections, Stool Flora, Stool Biochemistry, Constipation, Food Intolerance
- Keywords
- infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Waldkrankenhaus Protestant Hospital, SpandauUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 23 May 2012 (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.
The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.
Detailed description
An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial.
The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Formula | No intervention | –Standard formula with no supplementation |
| experimental formula | Experimental | Dietary Supplement: new infant formula with prebiotics and beta-palmitateinfant formula with higher beta-palmitate and supplemented GOS |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- healthy term neonates
- gestational age 37 to 42 weeks
- birth weight 10th to 90th percentile (Voigt reference)
- infants being exclusively formula-fed at enrollment
Key exclusion criteria (3 listed)
- infants with high risk of atopic disease due to family history
- congenital disorder or syndrome with need for special diet / impairment of growth
- antibiotic medication prior to enrollment
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 |
|---|---|---|
| new infant formula with prebiotics and beta-palmitateexperimental infant formula as sole source of nutrition over first 12 weeks of life | Dietary supplement | experimental formula |
Primary outcome
number of gastrointestinal infections
Time frame: within first year of life
8 secondary outcomes
proportion of bifidobacteria on total stool bacteria
Time frame: after 6 and 12 weeks intervention
number of infectious episodes (gastrointestinal, respiratory, fever episodes)
Time frame: within first year of life
anthropometric parameters (gain in weight, length, head circumference)
Time frame: after 6 weeks, after 12 weeks intervention
symptoms of food intolerance, constipation, colics
Time frame: after 6 weeks, 12 weeks intervention
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
Time frame: after 6 weeks, 12 weeks intervention
atopic manifestation
Time frame: within 1st year of life
erythrocytes´ fatty acid profile
Time frame: after 6 weeks intervention
calcium absorption
Time frame: after 6 weeks, 12 weeks intervention
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 9 Jun 2020.
- Derived from this study: PubMed 33934094Lambidou M, Alteheld B, Fimmers R, Jochum F, Nomayo A, Stehle P. Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns. Ann Nutr Metab. 2021;77(3):138-145. doi: 10.1159/000515705. Epub 2021 Apr 30.
- Derived from this study: PubMed 32613402Nomayo A, Schwiertz A, Rossi R, Timme K, Foster J, Zelenka R, Tvrdik J, Jochum F. Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial. Mol Cell Pediatr. 2020 Jul 2;7(1):6. doi: 10.1186/s40348-020-00098-1.
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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.
Frank Jochum, MD principal investigator
Waldkrankenhaus Protestant Hospital, Spandau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new infant formula with prebiotics and beta-palmitate in people with Infections and Stool Flora, run by Waldkrankenhaus Protestant Hospital, Spandau 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 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 9 Jun 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. 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 gastrointestinal infections (time frame: within first year of life). 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 NCT01603719, 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 9 Jun 2020.