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Safety


Long Term Follow-up Studies in Infants and Children

Reference

Rianda D, 2022
(Substudy of Agustina 2012) Indonesia

Study Objectives

To evaluate the long-term effect of probiotics (L. reuteri DSM 17938 or L. casei CRL431) and calcium supp lementation (low or regular) during childhood, on cognition, mood, behaviour, and serum BDNF levels in adolescents.

Study Design*

Original study: R, DB, PC

No. of Subjects (dose)

Low calcium (LC): 53 Regular calcium (RC): 70 RC + L. reuteri: 55 (5×108 CFU) RC + L. casei: 60 (5×108 CFU)

Results

• The L. reuteri group scored lower on the Children’s Depression Inventory compared to RC
• The L. casei CRL431 group scored higher on the Raven’s Progressive Matrices compared to RC
• The groups did not differ in Strength and Difficulties Questionnaire score
• The RC group had higher serum BDNF levels than LC Adverse events were not registered.

Reference

Abrahamsson TR, 2013
(Substudy of Abrahamsson 2007) Sweden

Study Objectives

In a study on prevention of allergy in newborns, L. reuteri ATCC 55730 reduced the incidence of IgE-asso ciated allergic disease in infancy. This treatment might therefore also reduce the risk of asthma and al lergic rhino conjunctivitis in school age, which this follow-up study set out to investigate. It also evaluated whether this supplementation was associated with any long-term side effects. The age at follow-up was 7y.

Study Design*

Original study: R, DB, PC

No. of Subjects (dose)

L. reuteri: 94 (1×108 CFU) Placebo: 90 In the 2007 trial 232 in fants were randomised and 188 completed

Results

• Growth indices and gastrointestinal symptoms were similar in the two groups
• No severe adverse events were reported

Reference

Stensson M, 2014
(Substudy of Abrahamsson 2007) Sweden

Study Objectives

To evaluate the effect on oral health, at age 9 years, of daily oral supplementation with the probiotic L. reuteri ATCC 55730, to mothers during the last month of gestation and to children throughout the first year of life.

Study Design*

R, SB, PC Multi-center

No. of Subjects (dose)

L. reuteri (5 drops/d): 60 (1×108 CFU) Placebo (5 drops/d): 53 Attrition rate of 40% compared to the initial 188 infants. Loss to follow-up was mainly due to family move from the area.

Results

Compared to placebo, L. reuteri significantly:
• Increased the proportion of caries free children: 82% vs. 58%
• Decreased the prevalence of approximal caries: 0.67 vs. 1.53 tooth surfaces
• decreased the number of sites with gingivitis

Reference

Ceratto S, 2014 (abstract, sub study of Savino 2010) Italy

Study Objectives

If probiotic reatment with L. reuteri DSM 17938 for infant colic may prevent atopic diseases (cow’s milk allergy and atopic dermatitis), asthma and migraine at the age of f ive, and effects on growth.

Study Design*

Original study: R, DB, PC

No. of Subjects (dose)

L. reuteri: 25 (1×108 CFU) Placebo: 23 In 2010 50 were rando mised at baseline and 46 analysed

Results

Growth was similar in the two groups, measured as BMI Z-score.