Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study
The objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydroly...
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| Language: | English |
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Cambridge University Press
2016-01-01
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| Series: | Journal of Nutritional Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2048679016000355/type/journal_article |
| _version_ | 1811155905101692928 |
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| author | M. Abrahamse-Berkeveld M. Alles E. Franke-Beckmann K. Helm R. Knecht R. Köllges B. Sandner J. Knol K. Ben Amor A. Bufe |
| author_facet | M. Abrahamse-Berkeveld M. Alles E. Franke-Beckmann K. Helm R. Knecht R. Köllges B. Sandner J. Knol K. Ben Amor A. Bufe |
| author_sort | M. Abrahamse-Berkeveld |
| collection | DOAJ |
| description | The objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydrolysed formula containing a specific combination of Bifidobacterium breve M-16V and a prebiotic mixture (short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio; scGOS/lcFOS; synbiotic group), or the same formula without this synbiotic concept for 13 weeks (control group). Anthropometry, formula intake, tolerance, stool characteristics, blood parameters, faecal microbiota and metabolic faecal profile were assessed. Medically confirmed adverse events were recorded throughout the study. Equivalence in daily weight gain was demonstrated for the intention-to-treat (ITT) population (n 211). In the per-protocol (PP) population (n 102), the 90 % CI of the difference in daily weight gain slightly crossed the lower equivalence margin. During the intervention period, the mean weight-for-age and length-for-age values were close to the median of the WHO growth standards in both groups, indicating adequate growth. The number of adverse events was not different between both groups. No relevant differences were observed in blood parameters indicative for liver and renal function. At 13 weeks, an increased percentage of faecal bifidobacteria (60 v. 48 %) and a reduced percentage of Clostridium lituseburense/C. histolyticum (0·2 v. 2·6 %) were observed in the synbiotic group (n 19) compared with the control group (n 27). In conclusion, this study demonstrates that an extensively hydrolysed formula with B. breve M-16V and the prebiotic mixture scGOS/lcFOS (9:1) supports an adequate infant growth. |
| first_indexed | 2024-04-10T04:42:32Z |
| format | Article |
| id | doaj.art-17bc043aa7334c7bb1a06e374e7b3fed |
| institution | Directory Open Access Journal |
| issn | 2048-6790 |
| language | English |
| last_indexed | 2024-04-10T04:42:32Z |
| publishDate | 2016-01-01 |
| publisher | Cambridge University Press |
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| series | Journal of Nutritional Science |
| spelling | doaj.art-17bc043aa7334c7bb1a06e374e7b3fed2023-03-09T12:38:50ZengCambridge University PressJournal of Nutritional Science2048-67902016-01-01510.1017/jns.2016.35Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre studyM. Abrahamse-Berkeveld0M. Alles1E. Franke-Beckmann2K. Helm3R. Knecht4R. Köllges5B. Sandner6J. Knol7K. Ben Amor8A. Bufe9Nutricia Research, Utrecht, The NetherlandsNutricia Research, Utrecht, The NetherlandsNETSTAP e.V., Bochum, GermanyNETSTAP e.V., Bochum, GermanyNETSTAP e.V., Bochum, GermanyNETSTAP e.V., Bochum, GermanyNETSTAP e.V., Bochum, GermanyNutricia Research, Utrecht, The Netherlands Laboratory of Microbiology, Wageningen University, Wageningen, The NetherlandsNutricia Research, Utrecht, The NetherlandsNETSTAP e.V., Bochum, Germany Experimental Pneumology, Ruhr-University Bochum, Bochum, GermanyThe objective of the present study was to evaluate the growth and tolerance in healthy, term infants consuming a synbiotic formula with daily weight gain as the primary outcome. In a randomised, controlled, double-blind, multicentre, intervention study infants were assigned to an extensively hydrolysed formula containing a specific combination of Bifidobacterium breve M-16V and a prebiotic mixture (short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides in a 9:1 ratio; scGOS/lcFOS; synbiotic group), or the same formula without this synbiotic concept for 13 weeks (control group). Anthropometry, formula intake, tolerance, stool characteristics, blood parameters, faecal microbiota and metabolic faecal profile were assessed. Medically confirmed adverse events were recorded throughout the study. Equivalence in daily weight gain was demonstrated for the intention-to-treat (ITT) population (n 211). In the per-protocol (PP) population (n 102), the 90 % CI of the difference in daily weight gain slightly crossed the lower equivalence margin. During the intervention period, the mean weight-for-age and length-for-age values were close to the median of the WHO growth standards in both groups, indicating adequate growth. The number of adverse events was not different between both groups. No relevant differences were observed in blood parameters indicative for liver and renal function. At 13 weeks, an increased percentage of faecal bifidobacteria (60 v. 48 %) and a reduced percentage of Clostridium lituseburense/C. histolyticum (0·2 v. 2·6 %) were observed in the synbiotic group (n 19) compared with the control group (n 27). In conclusion, this study demonstrates that an extensively hydrolysed formula with B. breve M-16V and the prebiotic mixture scGOS/lcFOS (9:1) supports an adequate infant growth.https://www.cambridge.org/core/product/identifier/S2048679016000355/type/journal_articleInfant growth Bifidobacterium breve M-16VHydrolysed formulaSynbioticsRandomised controlled trials |
| spellingShingle | M. Abrahamse-Berkeveld M. Alles E. Franke-Beckmann K. Helm R. Knecht R. Köllges B. Sandner J. Knol K. Ben Amor A. Bufe Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study Journal of Nutritional Science Infant growth Bifidobacterium breve M-16V Hydrolysed formula Synbiotics Randomised controlled trials |
| title | Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study |
| title_full | Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study |
| title_fullStr | Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study |
| title_full_unstemmed | Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study |
| title_short | Infant formula containing galacto-and fructo-oligosaccharides and Bifidobacterium breve M-16V supports adequate growth and tolerance in healthy infants in a randomised, controlled, double-blind, prospective, multicentre study |
| title_sort | infant formula containing galacto and fructo oligosaccharides and bifidobacterium breve m 16v supports adequate growth and tolerance in healthy infants in a randomised controlled double blind prospective multicentre study |
| topic | Infant growth Bifidobacterium breve M-16V Hydrolysed formula Synbiotics Randomised controlled trials |
| url | https://www.cambridge.org/core/product/identifier/S2048679016000355/type/journal_article |
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