Dataset Information

Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.

ABSTRACT:

Objective

To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).

Design

A prospective, randomised, double-blind, placebo-controlled crossover trial.

Setting

Two study sites in Italy and The Netherlands.

Study participants

Children with documented cow's milk allergy were eligible for inclusion in this trial.

Interventions

After a 7-day period of strict avoidance of cow's milk protein and other suspected food allergens, participants were tested with an EH casein formula with demonstrated hypoallergenicity (control, EHF) and a formula of the same composition with LGG added at 10(8) colony-forming units per gram powder (EHF-LGG) in randomised order in a double-blind placebo-controlled food challenge (DBPCFC). After absence of adverse reactions in the DBPCFC, an open challenge was performed with EHF-LGG, followed by a 7-day home feeding period with the same formula.

Main outcome measure

Clinical assessment of any adverse reactions to ingestion of study formulae during the DBPCFC.

Results

For all participants with confirmed cow's milk allergy (n=31), the DBPCFC and open challenge were classified as negative.

Conclusion

The EH casein formula supplemented with LGG is hypoallergenic and can be recommended for infants and children allergic to cow's milk who require an alternative to formulae containing intact cow's milk protein.

Trial registration number

http://ClinicalTrials.gov Identifier: NCT01181297.

SUBMITTER: Muraro A

PROVIDER: S-EPMC3298831 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.

Muraro Antonella A Hoekstra Maarten O MO Meijer Yolanda Y Lifschitz Carlos C Wampler Jennifer L JL Harris Cheryl C Scalabrin Deolinda M F DM

BMJ open 20120305 2

<h4>Objective</h4>To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG).<h4>Design</h4>A prospective, randomised, double-blind, placebo-controlled crossover trial.<h4>Setting</h4>Two study sites in Italy and The Netherlands.<h4>Study participants</h4>Children with documented cow's milk allergy were eligible for inclusion in this trial.<h4>Interventions</h4>After a 7-day period of strict avoidance of cow's milk protei ...[more]

PMID: 22396223

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Project description:AimTo investigate recruitment, retention, and estimates for effects of formula supplementation with Lactobacillus rhamnosus GG (LGG) on inflammatory biomarkers and fecal microbial community in infants with colic.MethodsA prospective, double-blind, placebo-controlled trial was conducted in otherwise healthy infants with colic. We screened 74 infants and randomized and analyzed results in 20 infants [9 receiving LGG (LGG+) and 11 not receiving LGG (LGG-)]. LGG was incorporated in the formula (Nutramigen(®)) (minimum of 3 × 10(7) CFU/d) in the LGG+ group. Fecal microbiota and inflammatory biomarkers, including fecal calprotectin (FC), plasma cytokines, circulating regulatory T cells (Tregs), and crying + fussing time were analyzed to determine optimal time points and effect sizes for a larger trial.ResultsRecruitment in this population was slow, with about 66% of eligible infants willing to enroll; subject retention was better (75%). These rates were influenced by parents' reluctance to volunteer their infant for a clinical trial and by their tendency to change formulas. The maximal difference of crying + fussing time was observed at day 14, comparing the 2 groups, with a mean difference of -91 (95%CI: -76, 259) min (P = NS). FC showed no significant difference, but the optimal time to determine a potential effect was at day 90 [with a mean difference of 121 (95%CI: -48, 291) μg/g stool], observing a lower level of FC in the LGG+ group. The fecal microbial communities were chaotic, as determined by Shannon's diversity index and not apparently influenced by the probiotic. No significant change was observed in plasma inflammatory cytokines or Tregs, comparing LGG+ to LGG- groups.ConclusionDesigning future colic trials involving a probiotic-supplemented formula for infants in the United States will require consideration for difficult enrollment. Infants with colic have major variations in feal microbiota and calprotectin, both of which improve with time, with optimal time points for measurement at days 14 and 90 after treatment.

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Dataset Information

Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.

Objective

Design

Setting

Study participants

Interventions

Main outcome measure

Results

Conclusion

Trial registration number

Publications

Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial.

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