Absence of adverse events in healthy individuals using probiotics – analysis of six randomised studies by one study group

2016 ◽  
Vol 7 (2) ◽  
pp. 161-169 ◽  
Author(s):  
L. Tapiovaara ◽  
L. Lehtoranta ◽  
T. Poussa ◽  
H. Mäkivuokko ◽  
R. Korpela ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lactobacillus Rhamnosus ◽  
Study Groups ◽  
Elderly Subjects ◽  
Study Group ◽  
Double Blind ◽  
Lack Of Information ◽  
Individual Participant ◽  
Live Bacteria ◽  
Study Population

Consumption of live bacteria as probiotic supplements is increasing. There is, however, a lack of information on the safety of ingested probiotics. The main objective of this study was to investigate the adverse events (AEs) of specific probiotics (Lactobacillus rhamnosus GG (LGG) alone or LGG in combination with L. rhamnosus Lc705, Propionibacterium freudenreichii JS, Bifidobacterium lactis BB12, or Bifidobacterium breve 99) studied in six of our study groups’ clinical trials, by analysing individual participant data. A secondary objective was to study AEs associated with the consumed probiotic species and mixtures in three specific categories; ‘gastrointestinal disorders’, ‘respiratory, thoracic and mediastinal disorders’ and ‘infections and infestations’. Six randomised, double-blind, placebo-controlled clinical studies by our study group were included in this AE analysis (study population n=1,909). All AE data were classified according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) v4.0. From the 26 CTCAE System Organ Classes, we identified AEs in 20 classes among 1,909 subjects. Probiotic ingestion did not result in statistically significant differences in AEs in different groups, when compared to placebo. A subgroup analysis of gastrointestinal, respiratory, thoracic and mediastinal disorders, infections and infestations, found no differences between the intervention groups or for different probiotic combinations (risk ratio (RR) = 0.97, 95% confidence interval (CI): 0.93-1.02, P=0.30; RR=0.99, 95% CI: 0.97-1.01, P=0.35; RR=0.99, 95% CI: 0.93-1.06, P=0.62, respectively). As a conclusion, ingestion of probiotic supplementations containing LGG alone, or LGG in combination with L. rhamnosus Lc705, P. freudenreichii JS, B. breve 99, or B. lactis BB12 did not seem to cause AEs in young and elderly subjects in this analysis.

scholarly journals Assessing Early Behavioral Indicators of Tolerance in Infants Receiving Formula with Added Lactobacillus rhamnosus GG (LGG)

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 998-998
Author(s):  
Fabiola Gutierrez-Orozco ◽  
Cheryl Harris ◽  
Jennifer Wampler ◽  
Carol Lynn Berseth
Keyword(s):  
Infant Formula ◽  
Repeated Measures ◽  
Lactobacillus Rhamnosus ◽  
Study Groups ◽  
Parent Report ◽  
Infantile Colic ◽  
Double Blind ◽  
Behavioral Indicators ◽  
Funding Sources ◽  
Over Time

Abstract Objectives To evaluate the nutritive effects of an infant formula with added LGG on early behavioral indicators of tolerance in infants experiencing crying and fussing often associated with infantile colic. Methods In this single-center, double-blind, controlled, parallel, prospective study, infants (14 to 28 days of age) determined to cry and/or fuss ≥3 hours/day for ≥3 days/week (in a one-week period) were randomized to receive one of two formulas over a 21-day feeding period: marketed partially hydrolyzed (PH) cow's milk-based infant formula (PH: n, 35) or a similar formula with added LGG (PH-LGG: n, 36). Parents/caregivers used a validated parent-report diary to record crying/fussing and awake/content behavior at three time points: Study Days 2–4 (baseline), Days 10–12, and Days 18–20 (Study End). The primary outcome, duration (hours/day) of crying/fussing (averaged over each three-day period), was analyzed by repeated measures, mixed-effects models. Results Birth characteristics (sex, race, weight) and age (days; mean ± SE) at study entry (PH: 19.7 ± 0.8; PH-LGG: 19.3 ± 0.8) were similar for study groups. No group differences in mean study formula intake (g/day) or mean achieved weight (g) at any study time point were detected. Completion rates were similar through Day 21 (PH: n = 33, 94%; PH-LGG: n = 33, 92%). Duration of crying/fussing (mean ± SE) decreased over time with no significant differences detected in the PH vs PH-LGG group at Baseline (4.8 ± 0.3 vs 4.0 ± 0.3; P = 0.086), Days 10–12 (3.5 ± 0.3 vs 2.6 ± 0.3; P = 0.056), and Days 18–20 (2.1 ± 0.3 vs 1.5 ± 0.3; P = 0.227). Duration of awake/content behavior increased over time with no significant differences detected in PH vs PH-LGG: Baseline (1.0 ± 0.5 vs 1.2 ± 0.5; P = 0.786), Days 10–12 (1.3 ± 0.5 vs 1.6 ± 0.5; P = 0.627), and Days 18–20 (2.1 ± 0.5 vs 2.2 ± 0.5; P = 0.884). By Study End, only 8 (24%) in the PH and 9 (27%) in the PH-LGG group continued to cry and/or fuss ≥3 hours/day for ≥3 days/week. Conclusions In the present pilot study, we identified a study population of infants early in life experiencing crying and fussing often associated with infantile colic. Both study formulas were well tolerated. Crying/fussiness decreased and awake/content behavior increased in both study groups over the course of the study. Funding Sources Mead Johnson Nutrition.

scholarly journals EFFECT OF SELECTED YOGA TECHNIQUES ALONG WITH ASHWAGANDHA AND VACHA IN DEPRESSION IN THE AGE GROUP 65–75 YEARS

2021 ◽  
pp. 65-68
Author(s):  
SOUMYA MELEPPURAKKAL ◽  
SUNITHA K ◽  
JAYAN D
Keyword(s):  
Combined Therapy ◽  
Holistic Approach ◽  
Study Groups ◽  
Warm Water ◽  
Treatment Modalities ◽  
Control Group ◽  
Study Group ◽  
Age Group ◽  
Study Population

Objective: The study was done to compare the effect of selected yoga techniques, drugs, and combined therapy in depression in geriatrics. Methods: 75 patients between 65 and 75 years of age with depression were included in the study which was assessed by HAM D Score. The study population was randomly allocated to one control group and two study groups. The control group was given Aswangandha and Vacha churna with warm water as anupana after food, selected yoga techniques in the first study group, and combined yoga and the drug were given to the second study group. Outcome variables were assessed for the groups after the 30th day and follow-up after 45 days. Results: The results obtained in the study were analyzed using the ANOVA test. Yoga along with drug experienced a comparatively greater reduction in HAM-D score after treatment and follow-up (p<0.05) than other groups. Conclusion: Holistic approach can bring a better and static result than applying the treatment modalities alone.

scholarly journals Effect of Lactobacillus rhamnosus GG Administration on Vancomycin-Resistant Enterococcus Colonization in Adults with Comorbidities

2015 ◽  
Vol 59 (8) ◽  
pp. 4593-4599 ◽  
Author(s):  
Shira Doron ◽  
Patricia L. Hibberd ◽  
Barry Goldin ◽  
Cheleste Thorpe ◽  
Laura McDermott ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lactobacillus Rhamnosus ◽  
Concomitant Administration ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Content Type ◽  
Stool Samples ◽  
Vancomycin Resistant ◽  
To Receive ◽  
Stool Cultures

ABSTRACTVancomycin-resistant enterococci (VRE) are endemic in health care settings. These organisms colonize the gastrointestinal tract and can lead to infection which is associated with increased mortality. There is no treatment for VRE colonization. We conducted a randomized, double-blind, placebo-controlled clinical trial to examine the safety and efficacy of administration of the probioticLactobacillus rhamnosusGG (LGG) for the reduction or elimination of intestinal colonization by VRE. Colonized adults were randomized to receive LGG or placebo for 14 days. Quantitative stool cultures for LGG and VRE were collected at baseline and days 7, 14, 21, 28, and 56. Day 14 stool samples from some subjects were analyzed by quantitative PCR (qPCR) for LGG. Patients were closely monitored for adverse events. Eleven subjects, of whom 5 received LGG and 6 received placebo, were analyzed. No differences in VRE colony counts were seen at any time points between groups. No decline in colony counts was seen over time in subjects who received LGG. LGG was detected by PCR in all samples tested from subjects who received LGG but was only isolated in culture from 2 of 5 subjects in the LGG group. No treatment-related adverse events were seen. We demonstrated that LGG could be administered safely to patients with comorbidities and is recoverable in some patients' stool cultures. Concomitant administration of antibiotics may have resulted in an inability to recover viable organisms from stool samples, but LGG DNA could still be detected by qPCR. LGG administration did not affect VRE colonization in this study. (This study was registered at Clinicaltrials.gov under registration no. NCT00756262.)

scholarly journals The role of yogurt enriched with lactobacillus rhamnosus GG culture in dental caries prevention

2022 ◽  
pp. 1-1
Author(s):  
Isidora Neskovic ◽  
Aleksandra Maletin ◽  
Jelena Brakoc ◽  
Bojan Petrovic ◽  
Sanja Vujkov ◽  
...  
Keyword(s):  
Milk Fat ◽  
Lactobacillus Rhamnosus ◽  
Probiotic Strain ◽  
Study Groups ◽  
Plaque Index ◽  
Mixed Dentition ◽  
Control Group ◽  
Study Group ◽  
Lactobacillus Rhamnosus Gg

Introduction/Objective. Contemporary tendencies suggest that probiotics can significantly reduce the prevalence of caries in children, so it can be considered that they have a positive effect on general and oral health. Lactobacillus rhamnosus GG (LGG) is a probiotic culture of particular importance in preventive dentistry. The aim was to assess the effects of consumption of probiotic strain Lactobacillus rhamnosus GG on the dental plaque accumulation in children with mixed dentition. Methods. Research included 90 children with mixed dentition (5-12 years old). First study group consumed 200 ml of Lactobacillus rhamnosus GG-enriched yogurt (B-Activ LGG, Dukat) daily for a period of 14 days, while the remaining 30 formed the second study group who consumed 200 ml of yogurt (Jogurt 1,5% milk fat, Imlek) with manually added powder from probiotic capsule (Wayaforte LGG capsule, Medis) daily for14 days. The control group consisted of 30 children who had regular diet during examination period. Silness-L?e plaque index and saliva pH (pH-Fix-0-14, Macherey-Nagel) were determined at baseline and also upon intervention completion. Results. An increase in pH values was observed in both study groups. In general sample, there is a significant decrease of mean plaque index values (p ? 0.001). Both study groups had significant decrease of mean plaque index values on the baseline and after 14 days consumption of yogurt. In the control group the number of subjects with decrease plaque index values did not correlate and no association was found. Conclusion. Consistent consumption of LGG culture-enriched yogurt inhibits dental film accumulation and promotes saliva pH increase in children with mixed dentition.

scholarly journals The Effectiveness of Synbiotic Preparation Containing Lactobacillus and Bifidobacterium Probiotic Strains and Short Chain Fructooligosaccharides in Patients with Diarrhea Predominant Irritable Bowel Syndrome—A Randomized Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 1999
Author(s):  
Barbara Skrzydło-Radomańska ◽  
Beata Prozorow-Król ◽  
Halina Cichoż-Lach ◽  
Emilia Majsiak ◽  
Joanna B. Bierła ◽  
...  
Keyword(s):  
Adverse Events ◽  
Controlled Trial ◽  
Bifidobacterium Longum ◽  
Lactobacillus Rhamnosus ◽  
Bifidobacterium Bifidum ◽  
Controlled Study ◽  
Bowel Habit ◽  
Double Blind ◽  
Global Improvement ◽  
Double Blind Placebo

The purpose of the randomized double-blind placebo-controlled trial was to assess the effectiveness of synbiotic preparation containing probiotic Lactobacillus rhamnosus FloraActive™ 19070-2, Lactobacillus acidophilus DSMZ 32418, Bifidobacterium lactis DSMZ 32269, Bifidobacterium longum DSMZ 32946, Bifidobacterium bifidum DSMZ 32403 and fructooligosaccharides in adult patients with diarrhea-dominant IBS (IBS-D). The study included eighty patients with moderate and severe IBS-D who were randomized to receive synbiotics or placebo for eight weeks. Finally, a total of sixty-eight patients finished the study. The primary endpoints included the assessment of the symptoms’ severity with IBS symptom severity scale (IBS-SSS), an improvement of IBS global symptoms with Global Improvement Scale (IBS-GIS) and adequate relief of symptoms after four and eight weeks of therapy. Secondary endpoints, which were collected by telephone interviewers three times a week included the assessment of individual IBS symptoms and adverse events. Synbiotic treatment in comparison to placebo significantly improved IBS-GIS (p = 0.043), and IBS-SSS score inducing a decrease in the total IBS-SSS (p = 0.042) and in domain-specific scores related to flatulence (p = 0.028) and bowel habit (p = 0.028) after four and eight weeks. Patients treated with synbiotics reported in weekly observations a significant amelioration in a feeling of incomplete bowel movements, flatulence, pain, stool pressure and diarrheal stools compared to those receiving placebo. There were no differences in adverse events between both groups. Concluding, the multi-strain synbiotic preparation was associated with a significant improvement in symptoms in IBS-D patients and was well-tolerated. These results suggest that the use of synbiotics offers a benefit for IBS-D patients. [Clinicaltrials.gov NCT04206410 registered 20 December 2019].

scholarly journals Impact of an Anesthesiology Rotation on Subsequent Endotracheal Intubation Success

2013 ◽  
Vol 5 (1) ◽  
pp. 70-73 ◽  
Author(s):  
Ted R. Clark ◽  
Edward J. Brizendine ◽  
Joseph C. Milbrandt ◽  
Kevin G. Rodgers
Keyword(s):  
Emergency Department ◽  
Emergency Medicine ◽  
Adverse Events ◽  
Endotracheal Intubation ◽  
Study Groups ◽  
Control Group ◽  
Study Group ◽  
Intubation Success ◽  
Level Of Training ◽  
Major Adverse Events

Abstract Background Endotracheal intubation (ETI) is an essential skill that emergency medicine residents learn throughout their training. Objective To evaluate the effect of implementing a postgraduate year (PGY)-1 anesthesiology rotation on ETI success in the emergency department during PGY-2. Methods Residents in the study group completed a 4-week PGY-1 anesthesiology rotation. During the first 6 months of PGY-2, we compared ETI performance of the study group with a control group who did not experience a PGY-1 anesthesiology rotation. Data recorded included date, level of training, first- and second-attempt success, rescue devices used, major adverse events, and intubation scenario. A Pearson χ2 test was used to compare first-attempt success, overall success (≤2 attempts), and adverse events rates between the 2 groups. Results Overall success rate for the study groups was 95.7% (111 of 116), compared with 94.5% (137 of 145) for the controls (P  =  66). First-attempt success for the study group was 78.4% (91 of 116), compared with 83.4% (121 of 145) for the control group; this was not statistically significant (P  = .30). Observed major and minor adverse events were similar: 19.0% for the study group (22 of 116) versus 24.8% (36 of 145) for the control group (P  = .26). Conclusions The addition of an anesthesiology rotation to the PGY-1 curriculum did not have a significant effect on ETI success or the rate of adverse events during the first 6 months of PGY-2. First-attempt overall success and adverse events of our PGY-2 study group were consistent with previously published studies.

Een Duits netwerk bij de voorbereiding van de Militärverwaltung in België (1939-1940)

2011 ◽  
Vol 69 (4) ◽  
pp. 289-305
Author(s):  
Etienne Verhoeyen
Keyword(s):  
Study Groups ◽  
Study Group ◽  
Student Group ◽  
German Army ◽  
The Future ◽  
French Speaking ◽  
The Government ◽  
Set Up ◽  
First World ◽  
Preparatory Work

Nadat Hitler in oktober 1939 beslist had een aanval in het Westen te ondernemen, werden in Keulen twee studiegroepen opgericht, die het toekomstig bezettingsregime van België en Nederland moesten voorbereiden. Er was een studiecommissie die geleid werd door de toekomstige leider van het Duits Militair Bestuur in België, Regierungspräsident Reeder, en daarnaast bestond een geheime studiegroep die de Sondergruppe Student werd genoemd. Deze bijdrage belicht het voorbereidend werk van de leden van deze studiegroep op het gebied van handel, industrie, recht, Volkstum en cultuur in België. De groep legde een grote belangstelling voor de Flamenfrage aan de dag en trok daarbij lessen uit de ervaringen met de bezetting van België tijdens de Eerste Wereldoorlog. Ofschoon er van diverse zijden in Duitsland werd op aangestuurd, hebben zowel de 'commissie Reeder' als de Sondergruppe de wederinvoering van de bestuurlijke scheiding van het Vlaams en Franstalig landsgedeelte, één van de 'verworvenheden' van het Vlaams activisme uit 1914-18, beslist afgewezen. De bijdrage laat ook de tegenstellingen zien die in Duitsland bestonden op het gebied van de beïnvloeding (ten voordele van Duitsland) in de te bezetten gebieden. ________ A German network in the preparation of the Militärverwaltung (Army administration) in Belgium (1939-1940)After Hitler had decided in October 1939 to carry out an attack on the West, two study groups were set up in Cologne in order to prepare the future occupational regime of Belgium and the Netherlands.  The future leader of the German Army Administration in Belgium, President of the Government Reeder chaired the study group, and in addition there was a secret study group called the Sondergruppe Student (Special Student Group).This contribution illuminates the preparatory work of the members of this study group in the area of trade, industry, law, Volkstum (nationality) and culture in Belgium. The group demonstrated a lot of interest in the Flamenfrage (Flemish question) and in doing so drew lessons from the experience of the occupation of Belgium during the First World War.Although people from various quarters in Germany aimed for the reintroduction of the governmental separation between  the Flemish and French speaking parts of the country, one of the 'achievements' of Flemish activism from the period of 1914-1918, both the 'Reeder committee' and the 'Sondergruppe' definitely dismissed it. This contribution also demonstrates the contradictions present in Germany in the area of influencing the territories to be occupied (in favour of Germany).

scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

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