Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) has been reported to increase bone mineral density in mice, but its effect on human bone is unknown.
The aim of this randomized, double-blind, placebo-controlled study was to investigate the effect of L. reuteri 6475 on bone loss in older women, 75-80 years old, with low bone mineral density. The study included 90 women who received L. reuteri 6475 (1×1010 CFU/day) or placebo for 12 months.
L. reuteri 6475 significantly reduced bone loss in older women with low bone mineral density.
Gastroesophageal reflux (GERD) is a condition when the gastric acid content flows back into the esophagus. Proton pump inhibitors (PPI) has become the first line therapy prescribed for children over one year with GERD. According to some research the use of PPI may be involved in the pathogenesis of small intestinal bacterial overgrowth (SIBO).
In this randomized, single-blind, placebo-controlled study 128 children with GERD were treated with PPI and L. reuteri Protectis (5 drops/day), or PPI and placebo, for 12 weeks. The prevalence of SIBO was determined by glucose hydrogen breath test before and after treatment. As reference, they were also compared to 120 healthy children.
L. reuteri Protectis significantly reduced the prevalence of SIBO in children with GERD treated with PPI. In addition, L. reuteri Protectis also reduced gastrointestinal symptoms in children with SIBO.
L. reuteri Protectis as adjuvant to PPI treatment may reduce the prevalence of SIBO.
Detection of the gas methane (CH4) in exhaled breath is positively correlated to constipation, according to some research. Intestinal CH4 can slow intestinal transit time, and directly inhibit gut motility. Whether these alterations are a cause or a consequence of constipation is unknown.
This is an open trial, investigating the effect of L. reuteri Protectis DSM 17938 on the frequency of bowel movements and the level of methane in exhaled breath. The subjects were 20 constipated adults, all presenting with methane in their breath. Lactulose breath test was used at baseline and after 4 weeks of consumption of L. reuteri Protectis (2 tablets per day)
Positive detection of CH4 was defined as: production of > 5 ppm of CH4 at any time during four hours after oral ingestion of a 200-ml solution with 10 g of lactulose (= lactulose breath test).
Methane production in constipated adults can be reduced by daily ingestion of L. reuteri Protectis for four weeks. Reduced production of methane was associated with normalized number of weekly bowel movements. Ingestion of L. reuteri Protectis seems to modify the composition or the metabolism of methane producers of the gut microbiota.
Open study to investigate if the eradication rate of H. pylori in adults is improved by L. reuteri DSM 17938, as an adjunct during 10-day eradication therapy and for 10 days thereafter. Forty-five (45) patients were included.
The rate of eradication was 93.3% (42/45). In 2/4 (50%) previously treated for H. pylori the infection was also eradicated.
Side effects were reported in 8 subjects: mild diarrhoea for a few days (n=5), and abdominal discomfort (n=3).
Proton pump inhibitor-tetracycline-metronidazole-L. reuteri therapy provided high eradication rates with few side effects, and excellent compliance.
A randomised, double blind, placebo-controlled, multi-centre study to evaluate the efficacy of L. reuteri DSM 17938 (Protectis) in prevention of nosocomial diarrhoea in children admitted to hospital for reasons other than diarrhoea, aged 1-48 months. 91 children were given L. reuteri and 93 the equivalent placebo for the length of the hospital stay.
L. reuteri did not affect the incidence of hospital-acquired diarrhoeal disease. In addition, there was no difference between the L. reuteri and placebo groups for any of the secondary outcomes, including adverse effects. Rotavirus vaccination status had no impact on the results.
The trial did not find any preventive effect of L. reuteri in the dosage of 10^9 CFU/day compared to placebo.
This was a repeat of the Wanke trial of 2012, but with a 10 times higher dose = 10^9 CFU/day. The baseline incidence of nosocomial diarrhoea in this high dose trial became however much lower than estimated, 7% instead of 33%, and consequently the number of included and analysed subjects in the trial became too low to be able to detect any statistically significant differences between the two groups. Therefore it is still an open question whether this dosage may work for this indication.
Pregnancy causes hormonal changes that increase the risk of developing gingivitis, which half of all pregnant women will experience. Research have suggested that women with pregnancy gingivitis may be more likely to deliver babies prematurely or with low birth weight than mothers with healthy gums.
This was a double blind, placebo-controlled study in 45 women with pregnancy gingivitis, but otherwise healthy, enrolled at the beginning of the third trimester. Participants were examined toevaluate the extent of gingivitis and plaque index, and instructed to continue with their usual brushing habits. They were randomly provided with a supply of lozenges to be consumed twice daily until birth, each containing 2×10^8 cfu of Lactobacillus reuteri Prodentis (L. reuteri ATCC PTA 5289 + DSM 17938, n=24)), or the equivalent placebo lozenges (n=21).
Within two days after birth (approximately seven weeks after enrolment), the participants were re-evaluated. Both gingival index and plaque index of the Prodentis group were significantly reduced compared to baseline, and compared to the placebo group (p<0.0001). Within the placebo group there were no significant changes versus baseline. Gingival index was categorized as 0 (no inflammation) in approximately 79% and 37% of the subjects in the probiotic and placebo group, respectively.
The conventional methods to maintain oral health during pregnancy are brushing, flossing and seeing a dentist or a dental hygienist. L. reuteri Prodentis lozenges may be a useful adjunct in the control of pregnancy gingivitis.
A double-blind, placebo-controlled trial in 93 children, aged 6-15 years, and with functional abdominal pain (Rome III criteria). The interventions were a chewable tablet with L. reuteri DSM 17938 at a dose of 10^8 cfu/day (n=47) or the equivalent placebo tablet (n=46), once daily. The intervention period was 4 weeks, with follow-up after another 4 weeks. The primary endpoints were frequency and intensity of abdominal pain.
L. reuteri Protectis significantly reduced the frequency and severity of functional abdominal pain in children.
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
A randomised, double blind, placebo-controlled trial set out to evaluate if 28 days of pre-administration with omeprazole (PPI) combined with L. reuteri (Lr) (strains DSM 17938 + ATCC PTA 6475 = Gastrus) may reduce the bacterial load on its own, and increase eradication rate, in H. pylori (Hp)-infected dyspeptic adults. Fifty-five subjects were randomised, whereof 25 completed in the L. reuteri + PPI group and 28 in the placebo + PPI group. Subjects who thereafter still were positive for Hp infection, received a l0-day triple eradication therapy. Follow-up was then conducted at day 90 after initiation of intervention.
Compared to baseline, there was a decline in the proportion of subjects positive for Hp infection one week after cessation of the 28-day supplementation period and at the follow-up at day 90, but with no significant differences between groups. At day 90, compared to baseline, the overall presence and severity of GI symptoms had improved to the same extent in the two groups, measured by GSRS (Gastrointestinal Symptoms Rating Score).
The administration of L. reuteri Gastrus combined with proton pump inhibitor (PPI) did not improve the rate of eradication of H. pylori.
A randomised, single blinded (effects analyst), multi-centre study on the efficacy of L. reuteri DSM 17938 in children aged 3 – 60 months, and treated in their homes for acute diarrhoea for five days. 29 children were randomised to the L. reuteri group and 31 to the control group. Both groups received conventional rehydration therapy, but the control group received no probiotic.
Compared to controls, duration of diarrhoea was significantly reduced, and at 48 hours 55% of the children were free from diarrhoea vs. 13% in the control group. From the 72nd hour of intervention, there was no difference between the two groups in the percentage of children with watery diarrhoea. No study-related adverse events were reported.
L. reuteri Protectis was effective in the management of acute diarrhoea in outpatient children:
Significantly reduced duration of diarrhoea
55% of children recovered after 48 hours
First study to show that L. reuteri Protectis is effective also in outpatient children