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Investigation of the Efficacy of Lactobacillus rhamnosus GG in Infants With Cow’s Milk Protein Allergy: a Randomised Double-Blind Placebo-Controlled Trial

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Abstract

This investigation has been performed to show the efficacy of Lactobacillus rhamnosus GG (LGG) together with milk-free diet in patients with cow’s milk protein allergy (CMPA). This multicentre prospective investigation has been performed in 0–12 months of age children diagnosed as CMPA clinically and biochemically. Patients have been randomly divided in to two groups. İnfants in probiotic group were received with cow’s milk protein free diet and per oral (p.o.) daily 1X109 CFU LGG and in placebo group with milk-free diet and placebo. Mothers of all breast-fed patients have been put on milk-free diet and all patients fed with formula, offered to extensively hydrolysed formula. Symptoms like diarrhoea, vomiting, mucousy or bloody stool, abdominal pain or distension, constipation, dermatitis and restiveness were recorded at the beginning and weekly during the receiving dietary by the investigator. One-hundred infants diagnosed CMPA were included in this double-blind placebo controlled study. Forty-eight infants placed in probiotic group and 52 in placebo group. After 4 weeks of receiving dietary, infants in probiotic group have showed statistically significant improvement in symptoms of bloody stool, diarrhoea, restiveness and abdominal distension (p ≤ 0.001). Whilst statistically significant improvement was also observed in symptoms of mucousy stool (p = 0.038) and vomiting (p = 0.034), no significant improvement were observed in abdominal pain (p = 0.325), constipation (p = 0.917) and dermatitis (p = 0.071). In this study we observed significant improvement in symptoms of infants diagnosed CMPA receiving dietary LGG with cow’s milk-free diet.

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Funding

This study was supported by funding from unconditional scientific support of the Mamsel Pharmaceutical Industry and Joint-Stock Company (Turkey).

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Authors and Affiliations

  1. Department of Pediatric Gastroenterology, Faculty of Medicine, Gaziantep University, Şehitkamil, 27310, Gaziantep, Turkey

    Ahmet Basturk

  2. Department of Pediatric Gastroenterology, Antalya Education and Research Hospital, Kazım Karabekir St, 07100, Antalya, Turkey

    İshak Isik

  3. Department of Pediatric Gastroenterology, Faculty of Medicine, Akdeniz University, Dumlupinar Bulvari-Campus, 07059, Antalya, Turkey

    Atike Atalay & Aygen Yılmaz

Authors
  1. Ahmet Basturk
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  2. İshak Isik
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  3. Atike Atalay
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  4. Aygen Yılmaz
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Contributions

Concept—A.B., A.Y.; design—A.B., İ.I.; supervision—A.Y.; resource—A.B., A.Y., A.A.; materials—A.B., A.Y., İ.I.; data collection and/or processing—A.B., A.Y., A.A.; analysis and/or interpretation—A.B., İ.I.; literature search—A.B., A.A., İ.I.; writing—A.B.; critical reviews—A.B., A.Y.

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Correspondence to Ahmet Basturk.

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Conflict of Interest

The authors declare that they have no conflict of interest.

Ethics Committee Approval

The approval of the Antalya Education and Research Hospital Ethical Committee for the Clinical Studies was obtained before the study initiated (date and number of ethic committee approval: 30 November 2017/18–01).

Informed Consent

Written informed consent was obtained from patients who participated in this study.

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Externally peer-reviewed.

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Basturk, A., Isik, İ., Atalay, A. et al. Investigation of the Efficacy of Lactobacillus rhamnosus GG in Infants With Cow’s Milk Protein Allergy: a Randomised Double-Blind Placebo-Controlled Trial. Probiotics & Antimicro. Prot. 12, 138–143 (2020). https://doi.org/10.1007/s12602-019-9516-1

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  • DOI: https://doi.org/10.1007/s12602-019-9516-1

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