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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Formula | No Intervention | Standard formula with no supplementation | |
| experimental formula | Experimental | infant formula with higher beta-palmitate and supplemented GOS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new infant formula with prebiotics and beta-palmitate | Dietary Supplement | experimental infant formula as sole source of nutrition over first 12 weeks of life |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of gastrointestinal infections | within first year of life |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of bifidobacteria on total stool bacteria | after 6 and 12 weeks intervention | |
| number of infectious episodes (gastrointestinal, respiratory, fever episodes) | within first year of life | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Jochum, MD | Waldkrankenhaus Protestant Hospital, Spandau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Waldkrankenhaus Spandau | Berlin | 13589 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33934094 | Derived | 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. | |
| 32613402 |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D003248 | Constipation |
| D000073923 | Food Intolerance |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| anthropometric parameters (gain in weight, length, head circumference) |
| 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 | after 6 weeks, 12 weeks intervention |
| stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools) | after 6 weeks, 12 weeks intervention |
| atopic manifestation | incidence atopic dermatitis | within 1st year of life |
| erythrocytes´ fatty acid profile | palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane) | after 6 weeks intervention |
| calcium absorption | urinary calcium-creatinin ratio, serum alkaline phosphatase | after 6 weeks, 12 weeks intervention |
| Nomayo 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. |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |