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Randomized Controlled Trial
. 2023 Nov 4;15(21):4674.
doi: 10.3390/nu15214674.

Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants

Lindsey Otten  1 , Elisabeth Schelker  1 , Hanna Petersen  1 , Antonia Nomayo  1 , Romy Conzade  2 , Julia Günther  2 , Andrea Grieger  2 , Frank Jochum  1   3 , On Behalf Of The Hasi Study Group
Affiliations
Randomized Controlled Trial

Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants

Lindsey Otten et al. Nutrients. .

Abstract

The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants' gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: n = 149, CF: n = 148) and 41 BF infants completed the study per protocol. All tolerance parameters were comparable between eHF and CF. Stool was predominantly soft and yellow in colour. Stool was more frequently green in eHF than CF. BF infants had more frequent stools, which were mainly watery or soft and yellow, and comparable IGSQ scores (descriptive). Irrespective of group, all gastrointestinal and sleep parameters showed signs of maturation with increasing age. In conclusion, eHF showed gastrointestinal tolerance as good as CF in healthy infants. Both formulae were well-tolerated.

Keywords: IGSQ; breastfed; digestibility; extensively hydrolysed whey protein; gastrointestinal tolerance; infant formula; infant nutrition; protein hydrolysate; sleeping; stool characteristics.

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Conflict of interest statement

L.O., E.S., H.P., A.N., F.J. are employed by the Evangelisches Waldkrankenhaus Spandau, a nonprofit hospital. The department does paid research for different companies in the field of infant nutrition. The employer and F.J. have received support for scientific and educational activities by companies that market food products for infants. F.J. is a member of the Nutritional Committee of the German Society of Pediatrics (Deutsche Gesellschaft für Kinder- und Jugendmedizin (DGKJ)), which tends to be biased towards breastfeeding, and advisor of the German Hospital Association (Deutsche Krankenhaus Gesellschaft (DKG)). R.C., J.G., and A.G. are employed by Hipp GmbH & Co. Vertrieb KG.

Figures

Figure 1
Figure 1
Flow chart of infant enrolment and distribution into formula-fed groups and the breastfed reference group (modified from Otten et al. [18]). a One infant could not be analysed within FAS due to eligibility criteria not met. V1: 30 ± 3 days; V4: 120 ± 3 days. CF: control formula; eHF: infant formula manufactured from extensively hydrolysed whey protein; FAS: full analysis set; n: number of observations; SP: study product; PPS: per protocol set; V: visit.
Figure 2
Figure 2
Mean daily stool frequency (daily number of stools; mean ± SD) from 3-day diary (PPS). Missing values in eHF: V4: n = 1. BF: breastfed reference group; CF: control formula; eHF: infant formula manufactured from extensively hydrolysed whey protein; n: number of observations; PPS: per protocol set; SD: standard deviation; V: visit.
Figure 3
Figure 3
Stool consistency from 3-day diary (% ± SD; PPS). Missing values in eHF: V1: n = 2; V4: n = 1. Missing values in CF: V3: n = 1. BF: breastfed reference group; CF: control formula; eHF: infant formula manufactured from extensively hydrolysed whey protein; PPS: per protocol set; V: visit.
Figure 4
Figure 4
Stool colour from 3-day diary (%; PPS). Missing values in eHF: V1: n = 2; V4: n = 1. Missing values in CF: V3: n = 1. BF: breastfed reference group; CF: control formula; eHF: infant formula manufactured from extensively hydrolysed whey protein; PPS: per protocol set; V: visit.
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