Wadhwa A 2022 India
To observe the role of L. reuteri DSM 17938 in reducing crying time in colicky infants in a routine clinical practice.
Prospective, observational 21 days
L. reuteri: 120 (1×108 CFU)
L. reuteri DSM 17938 was in colicky infants associated with a significant reduction in crying time, and showed improvement in maternal depression.
Chau K, 2015 Canada
Investigate the efficacy of L. reuteri DSM 17938 for the treatment of infant colic in breastfed infants ≤ 6 months.
R, DB, PC 21 days
L. reuteri: 24 (1×108 CFU) Placebo: 28
Compared to placebo:
• L. reuteri significantly improved colic symptoms by reducing median crying and fussing times at days 7, 14 and 21.
• The rate of responders (50% reduction in daily crying time) was significantly higher in the L. reuteri group compared with the control group at day 21.
Szajewska H W 2013 Poland
Efficacy of L. reuteri DSM 17938 on infant colic in infants younger than 5 months, exclusively or pre-domi nantly breastfed. Effect on screa ming intensity and family quality of life. The trial included follow-up one week after termination of ingestion of the study product.
R, DB, PC 21 days + 7 days follow up
L. reuteri: 40 (1×108 CFU) Placebo: 40
• L. reuteri significantly reduced daily crying time compared to placebo
• Significantly more responders on day 7, 14, 21 and 28 (follow up) compared to placebo
• Parents’ rating of screaming intensity and family quality of life was significantly decreased and increased, respectively, atall time points
Savino F, 2010 Italy
To study the effect of L. reuteri DSM 17938 on infant colic in infants 2-16 weeks old, and investigate changes in the faecal microbiota.
R, DB, PC 21 days
L. reuteri: 25 (1×108 CFU) Placebo: 21
• L. reuteri significantly reduced daily crying time compared to placebo
• Significantly more responders on day 7, 14 and 21 compared to placebo
• Reduced faecal E. coli and increased counts of lactobacilli in the L. reuteri group only
Savino F, 2021 Italy
To examine urinary metabolomic fingerprints and crying time in colicky breastfed infants.
R, DB, PC 28 days.
L. reuteri: 16 (1×108 CFU) Placebo: 16
Compared to placebo L. reuteri significantly reduced daily crying time from day 0 to day 28. Furthermore, L. reuteri was linked to an increase of urinary metabolites that might be related to an improvement of gut absorption.
Savino F, 2019 Italy
To investigate CC-Chemokine Receptor 7 (CCR7) and interleukin 10 (IL-10) expression in breastfed co licky infants treated with L. reuteri DSM 17938. The secondary outcome was to evaluate crying time.
R, DB, PC 28 days
L. reuteri: 21 (1×108 CFU) Placebo: 25
Compared to placebo L. reuteri significantly:
• Increased expression of CCR7
• Reduced crying time
No difference was observed for IL-10 after the study period in either group. The increased expression of CCR7 could be a response to the probiotic treatment, suggesting that this could be part of the mechanism for the positive effects on colic by L. reuteri.
Savino F, 2018a Italy
To evaluate crying time, changes in mRNA levels of transcription factors RORγ (Th17 cell marker) and FOXP3 (Treg marker), and to investigate gut microbiota and faecal calpro tectin in infants treated with L. reuteri DSM 17938 for infant colic.
R, DB, PC 30 days
L. reuteri: 32 (1×108 CFU) Placebo: 28
Compared to placebo L. reuteri significantly:
• Reduced crying time
• Increased FOXP3 concentration, resulting in a decreased RORγ/ FOXP3 mRNA ratio
• Reduced faecal calprotectin
Savino F, 2018b Italy
To investigate levels of Treg cells and TLR2 and TLR4 mRNA expression in infants with and without colic (<60 days old). The secondary outcome was the impact of L. reuteri DSM 17938 on Treg and TLR mRNA expression.
R, DB, PC 28 days
Control group wit hout colic: 25 With colic: L. reuteri: 18 (1×108 CFU) Placebo: 16
• At baseline there were no differences in mRNA levels of Treg cells, TLR2 or TLR4 between infants with or without colic.
• L. reuteri significantly decreased crying time (302.3±19.86 min/ day on day 0 vs 76.75±22.15 min/day on day 28, P=0.001) and increased FoxP3 mRNA expression.
• TLR2 and TLR4 mRNA expression increased in both groups.
Mi G-L, 2015 China
Evaluate the effects of L. reuteri DSM 17938 on colicky infants < 4 months old, exclusively or predo minantly breastfed: on rate of treat ment success, reduction in daily crying time, parent satisfaction and maternal depression.
R, DB, PC 4 weeks
L. reuteri: 20 (1×108 CFU) Placebo: 19
Significant effects compared to placebo:
• Treatment success (≥ 50% reduction of crying time vs. baseline) was 100% in the L. reuteri group vs. 16% in the placebo group.
• Reduction in mean daily crying time (from 201 to 32 min/d in the L. reuteri group vs. 201 to 121 min/d in the placebo group). Differences were significant at each weekly evaluation.
• Parental satisfaction (100% vs 16% in the placebo group).
• Improved maternal depression scores throughout the study period (Edinburgh postnatal depression scale).
• No report of adverse effects in any of the groups.
Sung V, 2014 Australia
Efficacy of L. reuteri DSM 17938 on infant colic in infants < 3 months, with mixed feeding types. Colic defined as daily combined screa ming or fussing of 180 minutes or more. Maternal mental health and family quality of life (QoL) were also studied.
R, DB, PC 28 days + follow-up at 6 months
L. reuteri: 67 (1×108 CFU) Placebo: 60
Other probiotics than L. reuteri were allowed for mothers and/or infants, and also use of proton pump inhibitor
Compared to placebo:
• At day 28 mean values: 49 min more daily screaming + fussing time in the L. reuteri group (p<0.02), due to more fussing time in this group
• At day 28 median values: no difference
• No difference in duration of screaming time
• No difference in number of episodes of screaming/fussing, or in sleeping time
• No difference between groups in family QoL or maternal mental health
Savino F, 2007 Italy
Efficacy on infant colic in infants 11–80 days old.
R, open 28 days
L. reuteri: 41 (1×108 CFU) Simethicone: 42
• L. reuteri significantly reduced daily crying time compared to simethicone
• On day 28, 95% were responders in the probiotic group vs. 7% in the simethicone group
Martinelli M, 2017 Italy
To compare the effectiveness of th ree alternative treatments of infant colic: A) a mixture of standardized extract of Matricaria chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (H122) compared with B) Lactobacillus reuteri DSM 17938, and C) simethi cone.
R, Open, multi-centre, 21 days + 7 days of follow-up
L. reuteri: 45 (1×108 CFU) Herbs + tyndallized L. acidophilus: 45 Simethicone: 43
• Rate of treatment success was significantly greater in Group A and B, 30/45 and 31/45, respectively vs. 19/43 in group C.
• Mean daily crying time was significantly reduced in both Group A (from 211.3 ± 40 min/day to 69.6 ± 59 min/day) and in Group B (from 201.6 ± 32.5 min/day to 58.1 ± 48.9 min/day) vs. Group C (from 199.5 ± 32 min/day to 106 ± 56.5 min/day).
• No significant difference was observed between Group A and B (p = 0.4).
• No adverse events were reported in any of the groups.
Karadag N, 2012 (abstract) Turkey
Efficacy on infant colic and mother’s postpartum depression comparing L. reuteri DSM 17938 with herbal drops and sterile water. Baby massage was practiced in all three groups.
R, open 21 days + follow-up of mother’s mental health after 2 months
L. reuteri: 25 (1×108 CFU) Herbal drops: 24 Sterile water: 25
• L. reuteri and sterile water significantly reduced daily crying time compared to herbal drops at three weeks
• At three weeks the daily crying time was 35 minutes in the L. reuteri group compared to 188 minutes in the sterile water group and 300 min in the herbal drops group
• A significant drop in depression and anxiety scores were seen only for mothers in the L. reuteri group at the follow-up at two months