Impact of a Single Dose of a Probiotic Nutritional Supplement (AB001) on Absorption of Ethylalcohol: Results From a Randomized Double-Blind Crossover Study.

Background: We conducted a prospective placebo-controlled double-blind randomized Study to assess the impact of a single dose of a nutritional Supplement (AB001) on alcohol absorption in healthy subjects. Other objectives were the impact on breath alcohol content, cognitive function 1 hour after alcohol uptake and tolerability. Method: A total of 24 healthy volunteers were enrolled into the study (12 male, 12 female, age: 28.3 ± 10.8 years, BMI: 23.5 ± 5.7 kg/m²). On the experimental day, they ingested a light breakfast together with a single dose (2 capsules) of AB001 (or placebo) and drank 2 moderate glasses of spirit (a total of 0.6 g/kg body weight). Breath alcohol tests and blood draws for determination of blood alcohol levels were performed for up to 6 hours. After crossover, the experiment was repeated in the following week. Areas under the curves were calculated to determine alcohol absorption rates. Results: There was a significant reduction of blood alcohol by 10.1% (P < .001) with AB001, when compared to placebo. There was a less pronounced but also significant reduction of alcohol in the breath test by 7.2% (P < .05). No difference in the cognitive function test between AB001 and placebo could be observed 60 minutes after alcohol ingestion (22.6 ± 8.0 seconds vs 23.0 ± 11.2 seconds, n.s.). The supplement uptake was well tolerated and there were no adverse events related to the study intervention. Conclusion: Uptake of a single dose of AB001 shortly before drinking alcohol significantly reduced plasma alcohol and breath alcohol concentrations, but the effect was less pronounced compared to chronic uptake as shown previously.

Chronic Uptake of A Probiotic Nutritional Supplement (AB001) Inhibits Absorption of Ethylalcohol in the Intestine Tract - Results from a Randomized Double-blind Crossover Study.

Background: Regular alcohol consumption, e.g. by social drinking, is a potential source of consecutive health problems in many countries worldwide. A probiotic nutritional supplement (AB001) has been developed to reduce alcohol absorption from the intestine tract and to mitigate potential health care risks. Methods: This randomized placebo-controlled double-blind crossover study was conducted with 24 healthy subjects (13 male, 11 female, age: 25.4 ± 7.7 years, BMI: 23.6 ± 2.5 kg/m²). The subjects were randomized to take 2 capsules/day of AB001 or placebo for 1 week prior to an alcohol exposure experiment. On the experimental day, they ingested a light breakfast and drank a moderate glass of spirit (0.3 g/kg body weight). Breath alcohol tests and blood draws for determination of blood alcohol levels were performed for up to 6 hours. After crossover, the experiment was repeated in the following week. Areas under the curves were calculated to determine alcohol absorption rates. Results: A significant reduction of blood alcohol levels by 70.3% (P < 0.005 vs. placebo) was seen with AB001, (breath test: -30.7%; P < 0.005 vs. placebo). No difference was seen in a cognitive function test performed 60 minutes after alcohol ingestion (22.4 ± 7.7 seconds vs. 22.7 ± 5.6 seconds, n.s.). There were no adverse events or serious adverse events reported in this study. Conclusions: One week of supplementation with AB001 resulted in a substantially reduced absorption of alcohol into the body. Regular uptake of AB001 may help to prevent liver and other organ damage, and may reduce the negative medical and economical impact of social drinking on the individual and the society.

Non-interventional study to collect data for the application of lidocaine gel 2% during scaling and root planing and professional mechanical plaque removal.

OBJECTIVES: Evaluation of the safety and efficacy of a topical lidocaine gel 2% (LG) during scaling and root planing (SRP) and professional mechanical plaque removal (PMPR). MATERIALS AND METHODS: The anesthetic effects as well as unwanted effects of LG prior to or during SRP and PMPR were evaluated in an observational, non-randomized, non-interventional study design. A total of 385 treatments were recorded in 68 study centers all over Germany. Rating of the anesthetic effect of LG by treating personnel and patients using a four-item verbal rating scale (VRS), tolerability, safety (adverse effects), and need for additional local injection anesthesia (ALI). RESULTS: In SRP as well as in PMPR, application of LG allowed a sufficiently pain-free therapy in more than 90% of the patients as stated on the VRS (SRP: 97.8%, PMPR: 93.75%). Overall, ALI was needed in only 4.23% of the patients treated (SRP: 5.3%, PMPR: 2.62%). One adverse effect occurred within the observation. CONCLUSIONS: Application of LG may offer a safe and effective way to achieve pain-free therapy in periodontal patients. CLINICAL RELEVANCE: Patient compliance is key to the success of periodontal maintenance therapy. Effective and safe pain control during various kinds of periodontal therapy might increase patient compliance and therefore contribute to the long-term treatment success, among other factors. With regard to the patients observed in this study, 47% had previously received periodontal maintenance therapy and were therefore familiar with the treatment and the associated pain.

Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial.

BACKGROUND: In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. METHODS/DESIGN: This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. DISCUSSION: A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. TRIAL REGISTRATION: ClinicalTrials (NCT01434589).