Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life |
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) |
Outcome Measures
Primary Outcome Measures
- Stool consistency [10 weeks]
Amsterdam Infant Stool Scale
Secondary Outcome Measures
- Bacteria Count [10 weeks]
number of the copy of DNA of Intestinal Flora Content
Eligibility Criteria
Criteria
Inclusion Criteria:
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
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Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
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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)
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Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)
Exclusion Criteria:
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Infants with major congenital abnormalities will be excluded.
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Infants with lack of data will also be excluded.
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Infants, whose parents don't agree with informed consent, will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul | Kucukcekmece | Turkey | 34303 |
Sponsors and Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
Investigators
- Study Director: Seda Yilmaz Semerci, Kanuni SSTRH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANCL034