This randomised, controlled, single-blinded, multi-centre study was performed to evaluate the efficacy of L. reuteri DSM 17938 in reducing parental discomfort due to infantile colic in a population of otherwise healthy infants.
105 infants aged less than 10 days were randomly assigned to receive five drops per day (10^8 CFU) of L. reuteri Protectis with vitamin D (n=51), or vitamin D only (n=54), for three months.
Primary endpoint was measured as use of pain relieving agents. Secondary endpoints was measured as percentage of infants that switched from an exclusive breastfeeding to partial or exclusive formula feeding and number of calls to the paediatricians and number of visits at paediatricians’ ambulatories due to infantile colic
The results showed
1) Significantly less use of pain relieving agents in infants supplemented with L. reuteri Protectis compared to control group
75% less use of simethicone
96% less use of cimetropium bromide
2) Fewer paediatric consultations in the L. reuteri Protectis group versus control
47% fewer visits to paediatricians
40% fewer phone calls to paediatricians
3) 63% less use of infant formula in the L. reuteri Protectis group in the first three months
L. reuteri Protectis reduced parental distress and was effective in the prevention of colic in healthy infants:
Less need of pain relieving agents
Lower number of paediatric consultations
Less use of infant formula
This study adds evidence to the previous study with L. reuteri Protectis and the beneficial effects in the prevention of infantile colic
This randomised, placebo-controlled, double-blind trial was performed to investigate the effectiveness of L. reuteri DSM 17938 (L. reuteri Protectis) for the treatment of infantile colic in breastfed infants, as compared to placebo.
42 colicky infants, exclusively or predominantly breastfed, were randomly assigned to receive five drops (10^8 CFU) per day of L. reuteri Protectis (n=21) or placebo (n=21) for 28 days.
Primary outcome was measured as rate of responders at day 28 (defined as reduction of daily crying time by ≥ 50% compared to baseline)
Secondary outcomes was measured as duration of mean daily crying time at day 7, 14, 21 and 28, parents satisfaction with treatment and reduction in maternal depression
No study-related adverse events were reported
The 5th study to prove significant effect by L. reuteri Protectis in breastfed or predominantly breastfed colicky infants. The first Chinese study confirming the findings of three European ones and one in North America. Already after one week, reduction in daily crying time can be expected. Prompt treatment with L. reuteri Protectis can also improve parental satisfaction and family functioning.
This double blind, placebo controlled and randomised study was conducted in Australia. It showed no superior effect for Lactobacillus reuteri on reduction of crying time compared to placebo. Its publication evoked critical responses on the selection of crying infants, which might have influenced the results of the study. These responses and comments by the investigators are found here.
This randomized, double-blind, placebo-controlled trial was conducted to investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants.
52 infants with colic, according to modified Wessel criteria, were assigned at random to receive L. reuteri DSM 17938 (10^8 colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.
Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L. reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P = .045). On day 21, a significantly higher proportion of infants in the L. reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P = .035; relative risk, 3.3; 95% CI, 1.55-7.03).
Administration of L. reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic.
This multicentre, double-blind, placebo-controlled study investigated whether Lactobacillus reuteri DSM 17938 (L. reuteri Protectis) during the first three months could reduce the onset of colic, constipation and regurgitation in term newborns and thereby reduce the socio-economic impact of these conditions. 589 healthy infants were randomised to supplementation with either Lactobacillus reuteri Protectis drops (1×10^8 CFU) or placebo once daily for 90 days. 468 infants completed the study.
53% less of inconsolable crying with L. reuteri Protectis compared to placebo at one month
After one month of intervention the infants in the Lactobacillus reuteri Protectis group cried less than half as long per day as the infants given placebo, 45 minutes compared to 96 minutes (p<0.01). The significant difference between the groups persisted to the end of the 3-month intervention.
30% more daily evacuations with L. reuteri Protectis compared to placebo at one month
The infants in the Lactobacillus reuteri Protectis group also had an improved gut motility, leading to significantly more daily evacuations and less regurgitation compared to the infants in the placebo group. There were no adverse events reported.
37% fewer daily regurgitations with L. reuteri Protectis compared to placebo at three months
The study also evaluated the cost/benefit of the supplementation. The assessment model used did not take into account indirect costs such as those related to parental anxiety and stress. Calculating the direct costs only, the investigators concluded that the use of Lactobacillus reuteri Protectis saved each family 88 euro. In addition to this the community saved 104 euro per child.
€88 saved in direct costs for each family using Lactobacillus reuteri Protectis compared to placebo
Prophylactic use of Lactobacillus reuteri Protectis during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition.
80 infants aged <5 months with colic and exclusively or predominantly (>50%) breastfed were randomly assigned to receive Lactobacillus reuteri DSM 17938 (Lactobacillus reuteri Protectis, 10^8 CFU) or placebo, once daily for 21 days. The primary outcome measures were the treatment success, defined as the percentage of children achieving a reduction in the daily average crying time ≥50%, and the duration of crying (minutes per day) at 7, 14, 21, and 28 days after randomization. In addition to this, the parents’ perception of the baby’s colic and the quality of life of the parents and the family were measured.
75% treatment success with supplementation of Lactobacillus reuteriProtectis compared to 18% in the placebo group within 2 weeks of treatment
*Follow-up 1 week after termination of intervention
The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 (p= 0.026), at day 14 (p<0.001), 21 (p<0.001) and 28 (p<0.001). Additionally, throughout the study period, the median crying time was significantly reduced in the probiotic group compared with the control group.
Moreover, in terms of the parents’ perception of the baby’s colic and quality of life, the study showed highly significant improvements in the probiotic group as compared to the placebo group.
56% reduction in crying time with Lactobacillus reuteri Protectis compared to 38% with placebo within 2 weeks of treatment
* Follow-up 1 week after termination of intervention
** Same median crying time/day (180 min), but significant differences in interquartile ranges between groups: 149-180 minutes in probiotic group and 150-201 in placebo group
Exclusively or predominantly breastfed infants with colic benefit from the administration of Lactobacillus reuteri Protectis compared with placebo.
A prospective study evaluating the effect of Lactobacillus reuteri DSM 17938 on crying time in fifty infants diagnosed with infantile colic, whereof 46 completed the trial (25 received Lactobacillus reuteri, 10^8 CFU once daily, and 21 placebo).
Faeces was analysed for changes in the numbers of certain members of the intestinal microbiota. The infants were all born at term, they were 2-16 weeks at recruitment, and exclusively breastfed during the study. The parents recorded the daily crying time, stool characteristics and any adverse events in a diary.
Median daily crying times in minutes/day were 370 vs. 300 on day 0 and 35.0 vs 90.0 (P=0.022) on day 21, in the Lactobacillus reuteri and placebo groups, respectively. The number of responders, defined as 50% reduction in crying time from baseline, was significantly higher in the Lactobacillus reuteri group versus the placebo group on days 7: 20 vs. 8 (P=0.006); day 14: 24 vs. 13 (P=0.007), and day 21: 24 vs 15 (P= 0.036). There was a significant increase in faecal lactobacilli (P=0.002) and a reduction in faecal E. coli in the Lactobacillus reuteri group only (P=0.001) during the study period. There were no differences in weight gain, defecation frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed.
Conclusion: Administration of Lactobacillus reuteri DSM 17938 to infants diagnosed with infantile colic reduced crying time significantly compared with placebo, and was well tolerated. The effect was seen already after one week, and it may be related to induced changes in the faecal microbiota, particularly E. coli.
Prospective, randomised study with the objective of investigating if the probiotic Lactobacillus reuteri could improve symptoms in colicky infants.
90 breastfed infants, aged 11 to 80 days, and with confirmed infantile colic, were randomly assigned to two treatments: Lactobacillus reuteri ATCC 55730, 10^8 CFU/day and administered in an oil suspension, or simethicone, 60 mg/day. Eighty-three infants completed the study. The baseline median daily crying time was 197 minutes in both groups.
After 7 days, crying time was significantly reduced in the probiotic group, 159 min/day, vs. 177 min/day in the simethicone group (P=0.005). By day 28 the crying time in the Lactobacillus reuteri group was reduced to 51 min/day, vs. 145 min/day in the simethicone group (P <0.001). On day 28, 95% (39/41) were responders in the probiotic group and 7% (3/42) in the simethicone group. No side-effects were observed in either group.
Conclusion: The intake of Lactobacillus reuteri resulted in significantly less crying time within one week of treatment compared to standard therapy in these infants. This effect was even more pronounced at the end of the 4-week study.