Study Objectives: Investigate the efficacy of L. reuteri DSM 17938 for the treatment of infant colic in breastfed infants ≤ 6 months.

Study Design: R, DB, PC, 21 days

Subjects and daily dose: 24 patients L. reuteri DSM 17938 (1x10⁸ CFU), 28 patients Placebo

Results:

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.

Study Objectives: Evaluate the effects of L. reuteri DSM 17938 on colicky infants < 4 months old, exclusively or predominantly breastfed: on rate of treatment success, reduction in daily crying time, parent satisfaction and maternal depression.

Study Design: R, DB, PC, 4 weeks

Subjects and daily dose: 20 patients L. reuteri DSM 17938 (1x10⁸ CFU), 19 patients Placebo

Results:

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.

Study Objectives: Investigate if oral supplementation with L. reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns, and in addition reduce the socio-economic impact of these conditions.

Study Design: R, DB, PC, 90 days, Multicentre study

Subjects and daily dose: 238 patients L. reuteri DSM 17938 (1x10⁸ CFU), 230 patients Placebo

Results:

Compared to placebo:

• Daily administration of L. reuteri early in life reduced the duration of daily inconsolable type of crying, frequency of regurgitation, and incidence of functional constipation in the first 3 months of life
• Private and public costs for the management of these conditions were significantly reduced for infants receiving L. reuteri

Study Objectives: Efficacy of L. reuteri DSM 17938 on infant colic in infants younger than 5 months, exclusively or pre-dominantly breastfed. Effect on screaming intensity and family quality of life. The trial included follow-up one week after termination of ingestion of the study product.

Study Design: R, DB, PC, 21 days + 7 days follow-up

Subjects and daily dose: 40 patients L. reuteri DSM 17938 (1x10⁸ CFU), 40 patients Placebo

Results:

• 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, at all time points

Study Objectives: 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.

Study Design: R, DB, PC, 21 days

Subjects and daily dose: 25 patients L. reuteri DSM 17938 (1x10⁸ CFU), 21 patients Placebo

Results:

• 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

Study Objectives: To investigate the effect of L. reuteri DSM 17938 in the treatment of functional abdominal pain (FAP) in children aged 4-18 years. This study was performed after interim analysis of Jadrešin 2017 in order reach the initial targeted sample size.

Study Design: R, DB, PC, 3 months + 1 month follow up

Subjects and daily dose: 24 patients L. reuteri DSM 17938 (1x10⁸ CFU), 22 patients Placebo

Results:

Compared to placebo, L. reuteri significantly:

• increased days without pain
• reduced intensity of pain at 4 months

Pooled data from both studies confirmed increased days without pain and reduced severity of pain.

Study Objectives: To investigate the effect of L. reuteri DSM 17938 in the treatment of functional abdominal pain (FAP) and irritable bowel syndrome (IBS) in children aged 4-18 years.

Study Design: R, DB, PC, 3 months + 1 month of follow-up

Subjects and daily dose: 26 patients L. reuteri DSM 17938 (1x10⁸ CFU), 29 patients Placebo

Results:

Results of interim analysis of the study:

• Significant increase in days free of pain in the L. reuteri group compared to placebo: 80% vs. 46% of study days.
• Both groups showed significant reduction in severity of pain compared to baseline.
• Results suggest an effect of L. reuteri also in children with IBS.

Study Objectives: To assess the efficacy of L. reuteri DSM 17938 on functional abdominal pain (FAP) in children aged 6-15 years, with the primary outcomes frequency and intensity of abdominal pain. Intensity measured by Hicks face scoring system, ranking 0=no pain and 10=very severe pain.

Study Design: R, DB, PC, 4 weeks + 4 weeks of follow-up

Subjects and daily dose: 47 patients L. reuteri DSM 17938 (1x10⁸ CFU), 46 patients Placebo

Results:

Compared to placebo:

• Frequency of pain was significantly reduced at 4 weeks with 1.9 vs. 3.6 episodes/week in the L. reuteri and placebo group, respectively.
• Intensity of pain was significantly reduced during the supplementation: 4.3 vs. 7.2 on Hicks scale. This effect that was sustained at the follow-up at 8 weeks: 4.8 vs. 6.4.
• For other GI symptoms there was a significant reduction in the incidence of abdominal distention and bloating in the L. reuteri group.

Study Objectives: To study if L. reuteri DSM 17938 affect functional abdominal pain in children aged 6-16 years.

Study Design: R, DB, PC, 4 weeks supplementation + 4 weeks follow-up

Subjects and daily dose: 30 patients L. reuteri DSM 17938 (2x10⁸ CFU), 26 patients Placebo

Results:

• Significantly reduced severity of abdominal pain during L. reuteri intake
• Reduction in pain sustained up to 4 weeks after cessation of L. reuteri
• Pain frequency decreased significantly during the 8 weeks in both groups

Eine randomisierte, dreifach-blinde, placebokontrollierte Studie mit L. reuteri DSM 17938 zeigte eine Zunahme der Antikörpertiter gegen SARS-CoV-2 bei gesunden Probanden nach 28 Tagen oder länger nach der Impfung. Die Studie legt nahe, dass die Supplementation mit Probiotika den langfristigen Schutz vor viralen Infektionen erhöhen kann.

Die Studie umfasste 159 gesunde Erwachsene, die weder zuvor mit SARS-CoV-2 infiziert waren noch gegen COVID-19 geimpft wurden. Die Teilnehmer erhielten entweder L. reuteri DSM 17938 + 10 Mikrogramm Vitamin D₃ oder ein Placebo, das nur Vitamin D₃ enthielt, über einen Zeitraum von 6 Monaten. Während des Interventionszeitraums wurden 12 Probanden infiziert und 17 wurden vollständig geimpft.

Das Ziel der Studie war es, die Auswirkungen der Supplementation mit L. reuteri DSM 17938 auf die spezifischen Antikörperantworten gegen SARS-CoV-2 nach einer natürlichen Infektion oder Impfung zu untersuchen. Obwohl der primäre Endpunkt, basierend auf den infizierten Personen, keine statistisch signifikante Unterschiede zwischen den beiden Gruppen zeigte, wiesen die geimpften Personen, die L. reuteri DSM 17938 einnahmen, 28 Tage oder länger nach der Impfung signifikant höhere IgA-Antikörper-Titer auf als die Placebo-Gruppe.

Die Studie wurde am Forschungszentrum für Ernährung-Darm-Gehirn-Interaktionen der Universität Örebro in Schweden durchgeführt.

"Unseres Wissens ist dies die erste Studie, die die Auswirkungen einer Probiotika-Supplementation auf die verschiedenen Klassen von Antikörpern gegen SARS-CoV-2, einschliesslich der neutralisierenden Antikörper gegen das Virus, in einer Antikörper-naiven Kohorte untersucht", sagte Professor Robert Brummer, einer der Forscher und Autoren der Studie.

Die Ergebnisse deuten darauf hin, dass L. reuteri DSM 17938 den langfristigen Schutz vor viralen Infektionen nach der Impfung verbessern kann.

Bereits Bekanntes zu diesem Thema

Es wurde gezeigt, dass Probiotika vor Atemwegsinfektionen schützen¹ und die Wirksamkeit bestimmter Impfungen erhöhen.² Eine frühere klinische Studie hat gezeigt, dass L. reuteri DSM 17938 Arbeitsabwesenheiten aufgrund häufig auftretender Infektionen reduziert.³

^{1) Maya-Barrios et al., Benef. Microbes 12 (2021). 2) Zimmermann P. and Curtis N. Vaccine, 36 (2018). 3) Gutiérrez-Castrellón P. et al., Pediatrics 133 (4) e904-9 (2014).}

Study Objectives: The effect of regular intake of L. reuteri DSM 17938 on the number of days of sick leave caused by respiratory and/or gastrointestinal diseases among male steelworkers.

Study Design: R, DB, PC, 90 days

Subjects and daily dose: 79 patients L. reuteri DSM 17938 (1x10⁸ CFU), 80 patients placebo, 242 patients randomized

Results: 

L. reuteri significantly reduced the incidence of diarrhoea, which was reported on 0.60 days for subjects of the L. reuteri group vs. 1.33 days in the placebo group. There was no difference in primary outcome of number of sick days due to respiratory or gastrointestinal symptoms. The dropout rate of randomized subjects was 34%.

Study Objectives: Evaluate if daily administration of L. reuteri DSM 17938 reduces the frequency and duration of diarrhoea episodes and respiratory tract infections (RTI) in Mexican day school children aged 6-36 months. A cost-effectiveness analysis was also made.

Study Design: R, DB, PC, 3 months of intervention, follow-up at 6 months

Subjects and daily dose: 168 patients L. reuteri DSM 17938 (1x10⁸ CFU), 168 patients Placebo

Results: 

Compared to placebo:

• L. reuteri significantly reduced the frequency and duration of episodes of diarrhoea and respiratory tract infection at both 3 and 6 months
• The number of doctor visits, antibiotic use, absenteeism from day school and parental absenteeism from work were significantly reduced
• The use of L. reuteri was associated with a reduction of costs by 36 US dollars (USD) for each case of diarrhoea, and by 37 USD for each case of RTI

Study Objectives: To investigate milk with low and regular calcium content, respectively, and the addition of probiotics (L. reuteri DSM 17938 or L. casei CRL431) to milk with regular calcium content, on the incidence and duration of diarrhoea and acute respiratory infections in healthy Indonesian children, 1-6y old.

Study Design: R, DB, PC, 6 months

Subjects and daily dose: 124 patients L. reuteri DSM 17938 (5x10⁸ CFU), 120 patients L. casei (5x10⁸ CFU), 124 patients low calcium milk, 126 patients regular calcium milk

Results: 

Only L. reuteri significantly reduced:

• Incidence of diarrhoea in children with lower nutritional status, irrespective of definition of diarrhoea
• Incidence of diarrhoea in all children when diarrhoea was defined as ≥ 2 loose/liquid stools/24h instead of ≥ 3 loose/liquid stools/24h

The interventions had no effect on incidence or duration of acute respiratory infection

Study Objectives: Prevention of common infections in day-care children 4–10 months old.

Study Design: R, DB, PC, 12 weeks

Subjects and daily dose: 68 patients L. reuteri DSM 17938 (1,2x10⁹ CFU), 73 patients Bb-12 (1,2x10⁹ CFU), 60 patients control

Results: 

L. reuteri significantly reduced (compared to Bb-12 and control):

• Days with fever
• Need to consult doctor and need of antibiotics
• Absence from day-care

Both probiotics significantly reduced:

• Episodes with fever
• Episodes and days with diarrhoea

Study Objectives: To study prevention of short-term illness, cold or GI infection, in healthy adults at a work place.

Study Design: R, DB, PC, 80 days

Subjects and daily dose: 94 patients L. reuteri DSM 17938 (1x10⁸ CFU), 87 patients placebo

Results: 

L. reuteri significantly reduced short-term sick leave due to cold or GI infection compared to placebo: 10.6% and 26.4%, respectively, reported sick-leave. Among the in total 53 shift-workers, the frequency was 0 vs. 33%.