Infant colic, excessive crying of unknown cause, is a major burden to families and effects about 10-30 % of infants. Despite decades of research, the exact cause and treatment of infant colic has remained elusive. The use of Lactobacillus reuteri (DSM 17938) in infant colic is somewhat controversial and hence, we designed this study to evaluate its efficacy in infantile colic. We recruited predominantly or exclusively breastfed infants, aged less than 4 months in a placebo controlled observational randomized study. Participants' were assigned to receive L. reuteri at a dose 10(8) colony forming units (n = 21) and placebo (n = 21). Placebo was an identical formulation without live micro-organisms. Treatment was given to subjects for 21 days and they were followed for 4 weeks. Treatment success (primary outcome), daily reduction in crying time, parent satisfaction and reduction in maternal depression (secondary outcomes) were assessed at the end of study period. Treatment success was observed in all infants (100 %) of the probiotic group while it was seen in 15.7 % of the placebo group. Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day (P < 0.01) from 200.9 ± 6.3 min/day in the probiotic group as compared to the placebo group (120.6 ± 20.0 min/day). Moreover, throughout the study period, parent's satisfaction and improvement in maternal depression (Edinburgh postnatal depression scale) was also significantly higher in the probiotic group. In our study population, reduction in crying time was significant (P < 0.01) even during first week of initiation of therapy. We conclude that L. reuteri (DSM 17938) reduces daily crying time and maternal depression during infantile colic. We suggest L. reuteri may be a safe and efficacious option for reducing infant colic.
OBJECTIVE: To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
DESIGN: Double blind, placebo controlled randomised trial.
SETTING: Community based sample (primary and secondary level care centres) in Melbourne, Australia.
PARTICIPANTS: 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
INTERVENTIONS: Oral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.
MAIN OUTCOMES MEASURES: The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
RESULTS: Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
CONCLUSIONS: L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN95287767.
OBJETIVO: Para determinar se a administração de Lactobacillus reuteri (L reuteri) DSM 17938 é benéfico em crianças amamentadas com cólica infantil.
FORMA DE ESTUDO: Oitenta crianças com idade <5 meses com cólica infantil (definidos como episódios de choro com duração de três ou mais horas por dia e que ocorram pelo menos 3 dias por semana no prazo de 7 dias antes da matrícula), que eram exclusiva ou predominantemente (> 50%) amamentavam foram aleatoriamente designados para receber L reuteri DSM 17938 (10 (8), unidades formadoras de colónias) (n = 40) ou um placebo idêntico aparecendo e degustação (n = 40), ambos por via oral, em 5 gotas, 1 vez ao dia, durante 21 dias. As medidas de resultados primários foram o sucesso do tratamento, definida como a percentagem de crianças atingindo uma redução no tempo médio diário choro ≥ 50%, e a duração do choro (minutos por dia) aos 7, 14, 21, e 28 dias após a randomização .
RESULTADOS: A taxa de respondedores ao tratamento foi significativamente maior no grupo de probióticos, em comparação com o grupo placebo no dia 7 (P = 0,026), no dia 14 (risco relativo (RR) de 4,3, IC de 95% 2,3-8,7), em dia 21 (RR 2,7, IC de 95% 1,85-4,1), e no dia 28 (RR 2,5, IC de 95% 1,8-3,75). Além disso, durante todo o período de estudo, o tempo de choro mediano foi significativamente reduzida no grupo de probióticos, em comparação com o grupo de controlo.
CONCLUSÃO: crianças amamentadas exclusivamente ou predominantemente com cólica infantil benefício da administração de L reuteri DSM 17938 em comparação com placebo.
BACKGROUND AND AIM: Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF).
METHODS: A prospective, double-blind, randomized cross-over trial was performed for a 1-month period in 115 formula-fed infants (ages 2 weeks-5 months) comparing 2 ARF (ARF-1: nonhydrolyzed protein, locust bean gum; ARF-2: specific whey hydrolysate, locust bean gum, specially treated starch). The primary endpoint was the incidence of regurgitation.
RESULTS: At inclusion, mean age was 9.1 weeks; anthropometric parameters did not differ between the groups. According to the intention-to-treat analysis, the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 (statistically significant difference between both ARF, P = 0.0091). The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 (P = 0.0265). There was no significant difference in stool frequency and consistency between both groups.
CONCLUSIONS: The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations. ARF-2 was statistically more effective than ARF-1. Comparative trials enable the selection of the best therapeutic option.
The aim of this paper was to investigate the effect of aromatherapy massage using lavender oil as a possible treatment for this condition. This research was carried out on a group of 40 infants between 2 and 6 weeks of age with a gestational age of 38-42 weeks and normal development and growth. All the infants weighed between 2500 and 4000 g at birth and all exhibited the signs of colic. Infants in the treatment group received abdominal massage by their mothers using lavender oil, while those in the control group were not subject to an intervention. The infants in both control and treatment groups were monitored once a week by the researchers, in total five times. The effect of the massage was measured in terms of changes in the length of time the infants cried per week. The use of aromatherapy massage using lavender oil was found to be effective in reducing the symptoms of colic.
Abstract: OBJECTIVE: The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias. METHODS: Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups. RESULTS: One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively). CONCLUSIONS: In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.
Objective To investigate whether acupuncture reduces the duration and intensity of crying in infants with colic. Patients and methods 90 otherwise healthy infants, 2-8 weeks old, with infantile colic were randomised in this controlled blind study. 81 completed a structured programme consisting of six visits during 3 weeks to an acupuncture clinic in Sweden. Parents blinded to the allocation of their children met a blinded nurse. The infant was subsequently given to another nurse in a separate room, who handled all infants similarly except that infants allocated to receive acupuncture were given minimal, standardised acupuncture for 2 s in L14. Results There was a difference (p=0.034) favouring the acupuncture group in the time which passed from inclusion until the infant no longer met the criteria for colic. The duration of fussing was lower in the acupuncture group the first (74 vs 129 min; p=0.029) and second week (71 vs 102 min; p=0.047) as well as the duration of colicky crying in the second intervention week (9 vs 13 min; p=0.046) was lower in the acupuncture group. The total duration of fussing, crying and colicky crying (TC) was lower in the acupuncture group during the first (193 vs 225 min; p=0.025) and the second intervention week (164 vs 188 min; p=0.016). The relative difference from baseline throughout the intervention weeks showed differences between groups for fussing in the first week (22 vs 6 min; p=0.028), for colicky crying in the second week (92 vs 73 min; p=0.041) and for TC in the second week (44 vs 29 min; p=0.024), demonstrating favour towards the acupuncture group. Conclusions Minimal acupuncture shortened the duration and reduced the intensity of crying in infants with colic. Further research using different acupuncture points, needle techniques and intervals between treatments is required.
