Clinical Evidence Supporting The Use Of EleCare® and EleCare® Jr In Infants and Children
Growth
Growth of healthy term infants fed an extensively hydrolyzed casein-based or free amino acid-based infant formula: a randomized, double-blind, controlled trial.
Borschel MW, Ziegler EE, Wedig RT, et al. Clin Pediatr. 2013;52(10):910-917.
This randomized, controlled trial compared the growth of healthy term infants fed EleCare to those fed an extensively hydrolyzed casein-based formula.
Two hundred thirteen infants, 0 to 9 days of age, were enrolled and followed until 112 days of age. One hundred thirty-four infants completed the study. Infants were randomized to receive either EleCare (Abbott Nutrition, Columbus, OH) or Nutramigen® (Mead Johnson Nutrition, Evansville, IN). Over the course of the study, weight and weight gain from 14 to 112 days of age were the same in both groups. Serum albumin concentrations at 112 days of age were similar between groups.
Results
Mean Weight Shown In Comparison With The World Health Organization Growth Standards For Males And Females.a
AF = amino acid-based formula; HF = extensively hydrolyzed casein-based formula
A Borschel MW, Ziegler EE, Wedig RT, et al. Clin Pediatr. 2013;52(10):910-917.
This study was conducted with a previous formulation of EleCare Unflavored without DHA/ARA.
Nutramigen is not a registered trademark of Abbott Nutrition.
Conclusion
EleCare supports normal growth of infants comparable to that of infants fed an extensively hydrolyzed casein-based formula during the first 4 months of life.
Hypoallergenicity & Growth
Hypoallergenicity and efficacy of an amino acid-based formula in children with cow’s milk and multiple food hypersensitivities.
Sicherer SH, Noone SA, Barnes Koerner, et al. J Pediatr. 2001;138(5):688-693.
The objective of the study was to determine the hypoallergenicity and efficacy of a pediatric amino acid-based formula, EleCare®, for children with cow’s milk allergy (CMA), multiple food allergies, and eosinophilic gastroenteritis.
A total of 31 children (median age, 23.3 months) with CMA were recruited to document hypoallergenicity by the criteria recommended by the American Academy of Pediatrics.1 The criteria require that at least 29 consecutive patients with CMA have negative blinded challenges with the test formula. This criterion shows with 95% confidence that at least 90% of children with documented CMA will not react to the formula.
Eighteen of the children (ages 13 months to 17 years) continued on EleCare. Growth and biochemistries were assessed at entry and after 4 months. No significant changes in National Center for Health Statistics weight or height z-scores from entry were found and no significant changes in serum albumin, transthyretin, retinol-binding protein, serum urea nitrogen, retinol, α-tocopherol, γ-tocopherol, or β-carotene were observed. Significant increases in hemoglobin (+0.8 g/dL, p=0.008), hematocrit (+2.6%, p=0.005), and serum ferritin (+10.6 ng/mL, p=0.002) were observed. There was no significant change in stool number or consistency over the 4-month period.
This study was conducted with a previous formulation of EleCare Unflavored without DHA/ARA.
Reference: 1. Kleinman RE, et al. Infant formulas and allergic disease (American Academy of Pediatrics Subcommittee on Nutrition and Allergic Disease). Report prepared for FDA under contract 223-86-2117, 1990.
Conclusion
The study concluded that EleCare was hypoallergenic and effective in maintaining normal growth for children with cow’s milk allergy and multiple food allergies.
Protein-Sensitive Colitis
Evaluation of a free amino acid-based formula in infants with presumptive food protein-induced proctocolitis.
Borschel MW, Antonson DL, Murray ND, et al. SAGE Open Med. 2014. doi:10.1177/2050312114551857.
Forty-three infants with presumptive food protein-induced proctocolitis were fed EleCare to evaluate the change in physician-rated symptom score from enrollment to study completion.
Infants ≤6 months of age with documented protein-sensitive colitis (PSC) were fed EleCare at 20 kcal/fl oz for 42 days. A physician-rated symptom score (PRSS) assessment of formula tolerance and symptoms of PSC was performed at study day 1 and study day 43 (exit). Ten symptoms were rated on a scale of 0=none to 3=severe. Significant decreases in PRSS from study day 1 to study day 43 were observed: 9.1 ± 0.5 and 4.8 ± 0.5, respectively (p<0.0001). A significant decrease in the daily number of stools was reported (p<0.0001), but there was no significant change in mean rank stool consistency (MRSC).
Results
Changes In Physician-Related Symptom Scores, Stooling Patterns, And Formula Intake For The FAS Group From Study Day 1 To Study Day 43.
Characteristic | Study Day 1 | Study Day 43 | P Value |
| Physician-related symptom score*,†,‡ (n=43) | |||
| Vomiting | 0.81 ± 0.16 | 0.30 ± 0.09 | 0.0079 |
| Spit-up | 1.65 ± 0.16 | 1.63 ± 0.16 | 0.9084 |
| Irritability not associated with sleep | 2.14 ± 0.16 | 0.93 ± 0.16 | <0.0001 |
| Stool frequency | 0.77 ± 0.15 | 0.02 ± 0.02 | <0.0001 |
| Blood in stool | 0.72 ± 0.14 | 0.09 ± 0.06 | 0.0002 |
| Difficulty passing stool | 0.88 ± 0.16 | 0.49 ± 0.11 | 0.0392 |
| Sleep problems | 1.35 ± 0.14 | 0.63 ± 0.16 | 0.0002 |
| Diaper rash | 0.40 ± 0.11 | 0.12 ± 0.06 | 0.0322 |
| Eczema | 0.37 ± 0.11 | 0.19 ± 0.08 | 0.1461 |
| Reactive airway disease | 0.00 ± 0.00 | 0.42 ± 0.16 | 0.0125 |
| Total score | 9.1 ± 0.5 | 4.8 ± 0.5 | <0.0001 |
| Daily number of stools§ (n=36) | 1.7 (1.3, 2.8) | 1.0 (0.7, 1.8) | <0.0001 |
| MRSC‡,ǁ,¶ (n=34) | 2.5 ± 0.1 | 2.4 ± 0.2 | NS |
| Formula intake, mL/kg/day‡,ǁ (n=36) | 151 ± 6 | 134 ± 6 | 0.0083 |
FAS=full analysis set; MRSC=mean rank stool consistency; NS=not significant; Q=quartile; SEM=standard error of the mean.
* Based on a 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe with specific criteria given for interpretation of each rating for each symptom, except reactive airway disease, which was scored as 0=no, 3=yes.
† Includes infants who exited from the study early.
‡ Mean SEM.
§ Median (Q1, Q3).
ǁ Includes infants with data at both study day 1 and study day 43.
¶ Mean rank stool consistency, scored as 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
This study was conducted with a previous formulation of EleCare Unflavored without DHA/ARA.
Conclusion
The study showed diminished symptoms associated with protein-sensitive colitis in infants receiving EleCare for 42 days.
Chronic Diarrhea in Infants and Children
Two single Group, prospective, baseline-controlled feeding studies in infants and children with chronic diarrhea fed a hypoallergenic free amino acid-based formula.
Borschel MW, Antonson DL, Murray ND, et al. BMC Pediatr. 2014;14:136.
These studies assessed the efficacy of EleCare® in supporting growth, dietary management, and improving symptoms in infants and children with chronic diarrhea (CD) from multiple etiologies. Other assessments included formula intake, tolerance of study feeding, stooling patterns and consistency, physician evaluation of clinical symptoms (at study day 1 and study day 84), and blood biochemistry levels. Two studies were conducted; each was a single-group, baseline controlled study in which each subject served as his/her own control.
At enrollment, all subjects had CD lasting >2 weeks and had ≥4 stools per day. Subjects were fed EleCare for 80 days starting at study day 5 and were assessed at study day 28 and study day 84.
Results
Diagnosis Of The Subjects Enrolled In The Study In Infants (CD-I) And In Children (CD-C)
Diagnosis* | CD-I (N=27) | CD-C (N=19) |
| Short bowel syndrome | 2 | 13 |
| Eosinophilic gastroenteritis | 7 | 5 |
| Food allergy | 20 | 5 |
| Inflammatory bowel disease | 0 | 2 |
| Maldigestion/malabsorption | 1 | 16 |
| Malnutrition | 2 | 3 |
| Gastroesophageal reflux | 0 | 1 |
| Viral enteritis/post-infectious gut mucosal injury | 2 | 0 |
| Formula intolerance | 2 | 0 |
* Some subjects had multiple diagnoses.
Adapted from Borschel MW, Antonson DL, Murray ND, et al. BMC Pediatr. 2014;14:136.
Infants
- 22 of 27 subjects completed the study. At enrollment, the mean age was 3.3 ± 0.3 months.
- The most common diagnosis was food allergy (n=20). No subjects were on parenteral nutrition (PN).
- Significant increase in weight-for-age z-scores, significant decrease in the number of stools per day, and improvement in stool consistency over the duration of the study were reported.
Children
- 18 of 19 subjects enrolled completed the study. At enrollment, the mean age was 5.6 ± 0.7 years.
- Some children had multiple diagnoses. The most common diagnosis was short bowel syndrome (n=13). Five of these subjects were on PN at enrollment.
- Over 50% of subjects showed improvement in clinical outcomes physicians most frequently targeted. Four of the 5 subjects on PN at enrollment had substantial weight gain, and 4 experienced a decrease in PN requirements over the duration of the study.
Physician-Targeted Clinical Outcomes
Clinical Outcome | CD-I (N=22) | CD-C (N=18) |
| Decreased stool number | 17 (100%) | 16 (69%) |
| Decreased vomiting | 6 (83%) | 7 (57%) |
| Decreased gas | 4 (100%) | 5 (80%) |
| Weight gain | 12 (92%) | 18 (83%) |
| Increased calorie intake | 2 (100%) | 4 (75%) |
Data expressed as: number of subjects at baseline having the outcome as target (% of targeted subjects who achieved the targeted outcome).
Adapted from Borschel MW, Antonson DL, Murray ND, et al. BMC Pediatr. 2014;14:136.
This study was conducted with a previous formulation of EleCare Unflavored without DHA/ARA.
Conclusions
Infants and children with CD fed EleCare for 3 months displayed significant improvements in weight-for-age z-scores and clinical symptoms. Children dependent on parenteral nutrition (PN) also grew well, and 4 out of 5 decreased their dependence on PN.
Eosinophilic Esophagitis
Eosinophilic esophagitis: a 10-year experience in 381 children.
Liacouras CA, Spergel JM, Ruchelli E, et al. Clin Gastroenterol Hepatol. 2005;3(12):1198-1206.
This study was not funded nor conducted by Abbott.
This retrospective study reflects the 10-year experience regarding the diagnosis, treatment, and management of all patients diagnosed with eosinophilic esophagitis (EoE) at Children’s Hospital of Philadelphia from January 1, 1994, to January 1, 2004 (n=381). Clinical symptoms, demographic data, endoscopic findings, and the results of various treatment regimens (including pharmacologic and dietary therapy) were collected and evaluated.
In this study, dietary therapy included the exclusion of select foods based on allergy testing or complete elimination of all foods with patients being placed on an amino acid-based hypoallergenic formula. Of the 247 patients who underwent dietary therapy, 132 patients underwent dietary restriction based on skin prick and patch testing, and 172 patients underwent complete dietary elimination using an amino acid-based formula (EleCare®; Abbott Nutrition, Columbus, OH or Neocate®; Neocate EO28; Neocate 1+; SHS International, Liverpool, UK). Of the 172 patients using an amino acid-based formula (AAF), 8 were noncompliant with the regimen.
Of the remaining 164 patients, 160 showed significant improvements in clinical symptoms and esophageal eosinophilia. Among the 160 patients who showed improvement on an amino acid-based diet:
- 26 (16%) continued to require the AAF as the mainstay of their diet because of the severity of their food allergy.
- 134 (84%) were able to discontinue the AAF as the major source for daily caloric needs from 3 to 18 months after initiation of formula. Of the patients who discontinued formula, only 3 reported ingesting a food previously known to cause EoE (at periods of 25, 46, and 63 months after initial esophageal histologic resolution).
Results
Significant Percentage Of Patients (N=160) feeding an amino acid-based formula whose clinical symptoms improved and average of esophageal eosinophils.
Adapted from Liacouras CA, Spergel JM, Ruchelli E, et al. Clin Gastroenterol Hepatol. 2005;3(12):1198-1206.
Neocate is not a registered trademark of Abbott.
