Feeding; Disorder, Nonorganic OriginNCT03770143
Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
An observational study of Feeding; Disorder, Nonorganic Origin and Calcium Disorder, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding; Disorder, Nonorganic Origin, Calcium Disorder, Intestinal Bacteria Flora Disturbance
- What is being tested?
- Feeding with palm olein formula
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Oct 2016
- Phase
- Observational
- 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 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally more than %70 with breast milk will be considered as breast-feeding. Infants who had not adequate weight gain and need formula will be randomized to receive either palm olein or palm olein free term formula in addition to mother milk. Parental informed consent will be taken and infants whose parents give permission will be included.
Who may be able to join
- The data of the patients who fulfilled the following criteria are evaluated.
- Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of > 2500grams who are either breastfed or formula fed.
- Selection of the subgroup using oral nutrition
- Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
- Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
- Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
Who cannot join
- Infants with major congenital abnormalities will be excluded.
- Infants with lack of data will also be excluded.
- Infants, whose parents don't agree with informed consent, will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
Read the detailed description
Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
- Conditions
- Feeding; Disorder, Nonorganic Origin, Calcium Disorder, Intestinal Bacteria Flora Disturbance
- Being tested
- Feeding with palm olein formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding with palm olein formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life Receives: Other: Feeding with palm olein formula | |
| Group 2 | Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life | |
| Group 3 | Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Amsterdam Infant Stool Scale
Measured: 10 weeks
Secondary outcomes (1)
Bacteria Count
number of the copy of DNA of Intestinal Flora Content
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study startMay 2016
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding; Disorder, Nonorganic OriginStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Seda Yilmaz Semerci, Study director, Kanuni SSTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770143
- Sponsor's protocol ID
- ANCL034
- Status last verified
- Dec 2018
- First submitted
- 11 May 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
- ClinicalTrials.gov ID
- NCT03770143
- Acronym / sponsor ID
- ANCL034
- Conditions
- Feeding; Disorder, Nonorganic Origin, Calcium Disorder, Intestinal Bacteria Flora Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Dec 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.
Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
Detailed description
Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Feeding with palm olein formulaInfants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life |
| Group 2 | – | –Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life |
| Group 3 | – | –Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height) |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally more than %70 with breast milk will be considered as breast-feeding. Infants who had not adequate weight gain and need formula will be randomized to receive either palm olein or palm olein free term formula in addition to mother milk. Parental informed consent will be taken and infants whose parents give permission will be included.
Key inclusion criteria (6 listed)
- The data of the patients who fulfilled the following criteria are evaluated.
- Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of > 2500grams who are either breastfed or formula fed.
- Selection of the subgroup using oral nutrition
- Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
- Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
Key exclusion criteria (3 listed)
- Infants with major congenital abnormalities will be excluded.
- Infants with lack of data will also be excluded.
- Infants, whose parents don't agree with informed consent, will be excluded.
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 |
|---|---|---|
| Feeding with palm olein formula | Other | Group 1 |
Primary outcome
Stool consistency
Time frame: 10 weeks
Amsterdam Infant Stool Scale
1 secondary outcome
Bacteria Count
Time frame: 10 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 23 Apr 2019.
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.
Seda Yilmaz Semerci study director
Kanuni SSTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding; Disorder, Nonorganic Origin and Calcium Disorder, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 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 23 Apr 2019. 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 Turkey (Türkiye). 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?
Stool consistency (time frame: 10 weeks). 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 23 Apr 2019.