Efficacy and safety of using premedication with simethicone/Pronase during upper gastrointestinal endoscopy examination with sedation: A single center, prospective, single blinded, randomized controlled trial.

BACKGROUND AND AIM: To investigate the efficacy and safety of premedication with simethicone/Pronase during esophagogastroduodenoscopy (EGD) with sedation. METHODS: Six hundred and ten patients were randomly allocated to two groups based on type of premedication given. Premedication used in the control group was 10 mL lidocaine hydrochloride mucilage (LHM, N = 314) and premedication used in the intervention group was 80 mL simethicone/Pronase solution plus 10 mL lidocaine hydrochloride mucilage (SP/LHM, N = 296). EGD was done under sedation. Visibility scores, number of mucosal areas that needed cleansing, water consumption for cleansing, time taken for examination, diminutive lesions, pathological diagnosis, patients' gag reflex and oxygenation (pulse oximetry) were recorded. RESULTS: SP/LHM has significantly lower total visibility score than LHM (7.978 ± 1.526 vs 6.348 ± 1.097, P < 0.01). During the procedure, number of intragastric areas that needed cleansing and amount of water consumed were significantly less in the SP/LHM than in the LHM group (P < 0.01). In SP/LHM (P = 0.01), endoscopy procedure duration was significantly longer. Although there was no significant difference in rate of detection of diminutive lesions between LHM and SP/LHM, the endoscopist carried out more biopsies in SP/LHM. This led to a higher rate of diagnosis of atrophic gastritis (P = 0.014) and intestinal metaplasia (P = 0.024). There was no significant difference in gag reflex (P = 0.604) and oxygenation during the endoscopy procedure for either group of patients. CONCLUSION: Routine use of premedication with simethicone/Pronase should be recommended during EGD with sedation.

Industrial antifoam agents impair ethanol fermentation and induce stress responses in yeast cells.

The Brazilian sugarcane industry constitutes one of the biggest and most efficient ethanol production processes in the world. Brazilian ethanol production utilizes a unique process, which includes cell recycling, acid wash, and non-aseptic conditions. Process characteristics, such as extensive CO2 generation, poor quality of raw materials, and frequent contaminations, all lead to excessive foam formation during fermentations, which is treated with antifoam agents (AFA). In this study, we have investigated the impact of industrial AFA treatments on the physiology and transcriptome of the industrial ethanol strain Saccharomyces cerevisiae CAT-1. The investigated AFA included industrially used AFA acquired from Brazilian ethanol plants and commercially available AFA commonly used in the fermentation literature. In batch fermentations, it was shown that industrial AFA compromised growth rates and glucose uptake rates, while commercial AFA had no effect in concentrations relevant for defoaming purposes. Industrial AFA were further tested in laboratory scale simulations of the Brazilian ethanol production process and proved to decrease cell viability compared to the control, and the effects were intensified with increasing AFA concentrations and exposure time. Transcriptome analysis showed that AFA treatments induced additional stress responses in yeast cells compared to the control, shown by an up-regulation of stress-specific genes and a down-regulation of lipid biosynthesis, especially ergosterol. By documenting the detrimental effects associated with chemical AFA, we highlight the importance of developing innocuous systems for foam control in industrial fermentation processes.

Simethicone to prevent colonic bubbles during CT colonography performed with polyethylene glycol lavage and iohexol tagging: a randomized clinical trial.

OBJECTIVE: The purpose of this study was to determine whether the occurrence of numerous colonic bubbles during CT colonography (CTC) performed with polyethylene glycol cleansing and oral iohexol fecal/fluid tagging could be prevented by use of simethicone. SUBJECTS AND METHODS: Adults with suspected colonic neoplasia who had been randomly assigned to control and simethicone intervention groups underwent CTC after cleansing with 4 L of polyethylene glycol, tagging with 50 mL of 350 mg I/mL oral iohexol, and without (control) or with (intervention) oral administration of 200 mg of simethicone. Colonic segments in the control and intervention groups were evaluated for amount of colonic bubbles during CTC. A 6-point grading system was used in which 0 indicated no bubbles and 5 indicated that more than three fourths of the air-distended mucosa was covered with bubbles. The primary endpoint was a per-patient colonic bubble grade, derived as an average of the segmental grades. RESULTS: Eighty adults with suspected colonic neoplasia were randomly assigned to the control (40 patients) and simethicone intervention (40 patients) groups. A total of 659 colonic segments in the control group and 689 segments in the intervention group were evaluated for amount of colonic bubbles during CTC. The per-patient colonic bubble score was significantly lower in the simethicone intervention group than in the control group. The mean score was 0.0±0.1 (SD) versus 1.2±0.8 (p<0.001; 95% CI for the mean difference, -1.4 to -1.0). In the intervention group, 673 (97.7%) segments were grade 0, and 16 (2.3%) were grade 1. In contrast, in the control group, 226 (34.3%) segments were grade 0; 173 (26.3%), grade 1; 175 (26.6%), grade 2; 45 (6.8%), grade 3; 23 (3.5%), grade 4; and 17 (2.6%), grade 5. CONCLUSION: The colonic bubbles associated with fecal/fluid tagging with iohexol can be successfully prevented by adding simethicone to the colonic preparation.

On recycling earth pressure balance shield muck with residual foaming agent: defoaming and antifoaming investigations.

Earth pressure balance (EPB) shield is increasingly employed in metro tunnel construction, and causes a series of environmental, safety, and resource waste problems due to the disposal of a considerable amount of muck. In situ recycling of EPB shield muck is an effective solution, whereas the foam is generated by residual foaming agents used as the muck conditioning material during tunnelling, which often adsorbs clay particles and overflows the flocculation tank. To achieve defoaming and antifoaming during the reuse of muck, this study prepared novel eco-friendly silicone oil-polyether defoamers by condensation, compounding, and shear emulsification. Defoaming and antifoaming performances of different defoamers were tested using a modified Ross-Miles method and a scale model of field flocculation systems. The results indicated that a high efficiency in defoam and antifoam was characterized by chemical grafting of nano-SiO2 from silicone oils, uniform distribution and large size of grains, low viscosity, and surface tension. The defoamer dosage of 0.002-0.004 wt% near critical micelle concentration (CMC) for each defoamer is reasonable. Overall, the prepared hydroxyl silicone oil-glycerol polyoxypropylene ether (H-G) defoamer compared with other silicone oil-polyether defoamers and commercial defoamers presents the highest defoaming and antifoaming efficiency. Considering the effects of EPB shield muck, the H-G defoamer is least affected by the compound materials and increasing concentration of the commercial foaming agent. Nevertheless, the stability of the H-G emulsion system is weaker than that of the dimethyl silicone oil-glycerol polyoxypropylene ether (D-G) emulsion system after 1 month of sealed storage.

Antifoam addition to shake flask cultures of recombinant Pichia pastoris increases yield.

BACKGROUND: Pichia pastoris is a widely-used host for recombinant protein production. Initial screening for both suitable clones and optimum culture conditions is typically carried out in multi-well plates. This is followed by up-scaling either to shake-flasks or continuously stirred tank bioreactors. A particular problem in these formats is foaming, which is commonly prevented by the addition of chemical antifoaming agents. Intriguingly, antifoams are often added without prior consideration of their effect on the yeast cells, the protein product or the influence on downstream processes such as protein purification. In this study we characterised, for the first time, the effects of five commonly-used antifoaming agents on the total amount of recombinant green fluorescent protein (GFP) secreted from shake-flask cultures of this industrially-relevant yeast. RESULTS: Addition of defined concentrations of Antifoam A (Sigma), Antifoam C (Sigma), J673A (Struktol), P2000 (Fluka) or SB2121 (Struktol) to shake-flask cultures of P. pastoris increased the total amount of recombinant GFP in the culture medium (the total yield) and in the case of P2000, SB2121 and J673A almost doubled it. When normalized to the culture density, the GFP specific yield (µg OD595⁻¹) was only increased for Antifoam A, Antifoam C and J673A. Whilst none of the antifoams affected the growth rate of the cells, addition of P2000 or SB2121 was found to increase culture density. There was no correlation between total yield, specific yield or specific growth rate and the volumetric oxygen mass transfer coefficient (k(L)a) in the presence of antifoam. Moreover, the antifoams did not affect the dissolved oxygen concentration of the cultures. A comparison of the amount of GFP retained in the cell by flow cytometry with that in the culture medium by fluorimetry suggested that addition of Antifoam A, Antifoam C or J673A increased the specific yield of GFP by increasing the proportion secreted into the medium. CONCLUSIONS: We show that addition of a range of antifoaming agents to shake flask cultures of P. pastoris increases the total yield of the recombinant protein being produced. This is not only a simple method to increase the amount of protein in the culture, but our study also provides insight into how antifoams interact with microbial cell factories. Two mechanisms are apparent: one group of antifoams (Antifoam A, Antifoam C and J673A) increases the specific yield of GFP by increasing the total amount of protein produced and secreted per cell, whilst the second (P2000 or SB2121) increases the total yield by increasing the density of the culture.

The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review.

BACKGROUND/AIM: To assess the efficacy and safety of simethicone with or without N-acetylcysteine (NAC) as premedications before gastroscopy. MATERIALS AND METHODS: We searched EMBASE, PubMed, Cochrane library and Web of Science database for randomized clinical controlled trials regarding simethicone ± NAC as oral drinking agents before gastroscopy. Statistical software RevMan5.3 was used for statistical analysis. RESULTS: Ten randomized clinical trials that fulfilled the inclusion criteria were further pooled into a meta-analysis, which included 5,750 patients. The rate of positive findings in simethicone plus NAC group was higher than that in water group (risk ratio [RR] =1.31, 95%CI: 1.12-1.53, P = 0.0006) with high level of evidence. There was no significant difference on the rate of positive findings when comparing simethicone with simethicone plus NAC (RR = 1.02, 95%CI: 0.90-1.16, P = 0.71) and with water (RR = 1.13, 95%CI: 0.82-1.55, P = 0.46), respectively. Simethicone plus NAC showed better total mucosal visibility score than simethicone alone (MD = -0.14 (-0.25, -0.03), P = 0.01) without obvious heterogeneity. Both simethicone plus NAC and simethicone alone offer more benefit than water. The procedure time in simethicone group was shorter than that in water group (MD = -1.23 (-1.51, -0.96), P < 0.00001). Regarding adverse events, there was no significant difference in simethicone and water group (RR = 0.45, 95%CI: 0.2-1.0, P = 0.05, I2 = 0%). CONCLUSIONS: As premedication of gastroscopy, simethicone plus NAC offers more benefit on positive findings and total mucosal visibility score.

Production of bio-ethanol from soybean molasses by Saccharomyces cerevisiae at laboratory, pilot and industrial scales.

The aim of this work was to develop an economical bioprocess to produce the bio-ethanol from soybean molasses at laboratory, pilot and industrial scales. A strain of Saccharomyces cerevisiae (LPB-SC) was selected and fermentation conditions were defined at the laboratory scale, which included the medium with soluble solids concentration of 30% (w/v), without pH adjustment or supplementation with the mineral sources. The kinetic parameters - ethanol productivity of 8.08g/Lh, YP/S 45.4%, YX/S 0.815%, m 0.27h(-1) and microX 0.0189h(-1) - were determined in a bench scale bioreactor. Ethanol production yields after the scale-up were satisfactory, with small decreases from 169.8L at the laboratory scale to 163.6 and 162.7L of absolute ethanol per ton of dry molasses, obtained at pilot and industrial scales, respectively.

To prep or not to prep - that is the question: A randomized trial on the use of antiflatulent medication as part of bowel preparation for patients having image guided external beam radiation therapy to the prostate.

INTRODUCTION: Radiation therapy is a standard treatment option for prostate cancer. With growing use of escalated doses and tighter margins, procedures to limit rectal size variation are needed to reduce prostate motion, increase treatment accuracy, and minimize rectal toxicity. This prospective study was done to determine whether the introduction of an antiflatulent medication would decrease rectal distention at computed tomography (CT) simulation and throughout a course of radiation therapy. METHODS AND MATERIALS: Patients undergoing a radical course of radiation therapy to the prostate/prostate bed were eligible to participate. Participants were randomly assigned to the intervention arm (antiflatulent medication) or the control arm (no medication). For each participant, the number of CT simulation rescans was recorded. Rectal diameters were measured on CT simulation and treatment cone beam CT scans. Acute rectal toxicities were assessed at baseline and weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. A χ2 analysis was used to compare the number of participants requiring a rescan in each study arm. Change in rectal diameter over time was assessed using repeated measures analysis of variance. RESULTS: A total of 78 patients participated, with equal numbers assigned to each study arm. There was no significant difference between arms in the number of participants requiring a CT simulation rescan (P = .5551). There was no significant variation in rectal diameter between arms (P = .8999); however, there was a significant effect of time (P = .0017) and a significant interaction effect between study arm and time on rectal diameter (P = .0141). No acute rectal toxicities above grade 2 were reported. CONCLUSIONS: The addition of antiflatulent medication did not affect the frequency of CT simulation rescans. Both time and the interaction between study arm and time had a statistically significant effect on rectal diameter, although neither finding was clinically significant. Instead, standardized bowel preparation education developed for this study may have been sufficient to limit rectal size variation.

Effects of anti-foaming agents on biohydrogen production.

The effects of antifoaming agents on fermentative hydrogen production using galactose in batch and continuous operations were investigated. Batch hydrogen production assays with LS-303 (dimethylpolysiloxane), LG-109 (polyalkylene), LG-126 (polyoxyethylenealkylene), and LG-299 (polyether) showed that the doses and types of antifoaming agents played a significant role in hydrogen production. During batch tests, LS-303 at 100µL/L resulted in the maximum hydrogen production rate (HPR) and hydrogen yield (HY) of 2.5L/L-d and 1.08mol H2/mol galactoseadded, respectively. The following continuously stirred tank reactor operated at 12h HRT with LS-303 at 100µL/L showed a stable HPR and HY of 4.9L/L-d and 1.17mol H2/mol galactoseadded, respectively, which were higher than those found for the control reactor. Microbial community analysis supported the alterations in H2 generation under different operating conditions and the stimulatory impact of certain antifoaming chemicals on H2 production was demonstrated.

Observations on the behavior of barium sulfate contrast media in vitro.

The double contrast method in the examination of the stomach has made possible the radiologic diagnosis of the surface lesions of the mucosa, eg, erosions and early gastric cancer. Changes in the patterns of areae gastricae can be visualized with a good contrast medium. We used a new, more physiologic in vitro method to compare contrast media and study the amounts of adsorption, the degrees of visualization of areae gastricae, and the effects of antifoam solution and blood on media adsorption. EZ-HD surpassed other contrast media on the Scandinavian market in total adsorption on the mucosa and the visualization of areae gastricae. Blood significantly reduces the adsorption of all media, while antifoaming agents have little or no effect.

Effect of silicone antifoam on shear sensitivity of hybridoma cells in sparged cultures.

Addition of high concentrations of silicone antifoam (AF) to a suspension of hybridoma cells in a bubble column reduces the death rate when using medium without a protective component. In contrast, high AF concentrations can cause detrimental effects in a sparged medium with a protective component, such as is applied for large-scale animal cell cultures.

Effect of Spumol K on the ultrastructure of Aspergillus niger strains sensitive or resistant to toxic compounds of beet molasses.

Aspergillus niger strains sensitive and resistant to toxic compounds of beet molasses grown in the presence of Spumol K were the object of the present studies. The antifoamer used diminished the number of mitochondria in both groups of strains and caused the reduction of their cristae in the sensitive ones. The disturbances in the ultrastructure of nucleus and mitochondria appeared mostly in sensitive strains. On the other hand, Spumol K presence in resistant strains not only increased the number of deposits of electron dense material in mitochondria, vacuoles, cytoplasm and in nuclear envelope but also was responsible for multivesicular body formation. The differences also existed in the ultrastructure of the cell wall: in the sensitive strains treated with Spumol K, the cell wall was completely deprived of fibrillar component, only granular component was present. In the resistant strains, granular component dominated, although fibrillar one was still visible. The present studies suggest that antifoamer in resistant strains becomes inactivated in different cell compartments, therefore its toxicity is lower than in sensitive strains where defence mechanism, inactivating toxic substances, is weaker and toxicity stronger.

Fermentation studies of rustmicin production by a Micromonospora sp.

The antifungal antibiotic rustmicin was detected in the fermentation broth of the actinomycete MA 7094 as a specific inhibitor of sphingolipid biosynthesis in Candida albicans and as a potent fungicidal agent against Cryptococcus neoformans. Taxonomic characterization by both classical means and PCR fingerprinting supported the assignment of the producing culture to the genus Micromonospora. Fermentation medium optimization studies showed that the concentration of tomato paste in the medium was critical to increased production of rustmicin by MA 7094. The stimulatory effect of tomato paste in the medium on rustmicin production appeared to be related to the maintenance of pH at or below a value of 6.0. Addition of the antifoam agent P-2000 to the fermentation was found to dramatically reduce the rustmicin titer, while substitution of another antifoam agent, UCON-LB625, resulted in a 100% increase in the amount of rustmicin detected. After fermentation optimization studies and the generation of a non-sporulating mutant of MA 7094, the rustmicin titer was increased from an initial titer of 10mg/liter to 145 mg/liter.

Production of a Pseudomonas lipase in n-alkane substrate and its isolation using an improved ammonium sulfate precipitation technique.

Among the various lipidic and non-lipidic substances, normal alkanes within the chain lengths of C-12 to C-20 served as the best carbon substrates for the production of extracellular lipase by Pseudomonas species G6. Maximum lipase production of 25 U/ml of the culture broth was obtained by using n-hexadecane as the sole carbon substrate. The optimum pH of 8 and temperature of 34 + 1 degrees C were demonstrated for the production of lipase in n-hexadecane substrate. The optimum concentration of iron, which played a critical role on the lipase production, was found to be 0.25 mg/l. Lipase production could be enhanced to nearly 2.4-fold by using tributyrin at a concentration of 0.05% (v/v) in the culture medium. High recovery of the lipase protein (83%) from the culture broth was achieved by treating the culture supernatant with Silicone 21 Defoamer followed by ammonium sulfate (60% saturation) fractionation.

The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers.

A method is described for inducing experimental aerogastria (flatulence) in human volunteers by the ingestion of "whipped" egg-white. Abdominal ultrasonography was used to measure the distension of the stomach and its interference with the visualization of organs such as gall bladder, pancreas and left kidney lying behind the stomach. A double-blind crossover comparison of Flatoril, a mixture of dimethicone (200 mg) and clebopride (0.5 mg) against placebo clearly demonstrated the superior antifoaming activity of the former both in terms of reduced gastric distension and of improved visualization of organs otherwise hidden by the foam-filled stomach.

[Antifoaming agent microembolism in patients undergoing extracorporeal circulation. Its frequency in post mortem material and its pathogenic potential in vitro]. / Microembolias de antiespumante en pacientes sometidos a circulación extracorpórea. Frecuencia en material post mortem y su potencial patógeno in vitro.

Antifoam microembolisms in patients that undergo open heart surgery, represent a risk for postoperative complications. We decided to study its frequency in an autopsy population of patients who died after heart surgery. Forty-five patients were selected and histological sections from the kidneys were studied under light microscopy, scanning electron microscopy and X-ray microanalysis. Thirty-six cases (80%) showed microemboli in the glomerular capillaries lumens. There was a positive correlation between the number of particles found and the length of the surgery. Microemboli were composed of an amorphous fraction and a particulated one composed of silicon. In vitro experimentation demonstrated that the particles are capable to induce cell lysis in a dose related manner. They also are susceptible of been phagocitated by macrophages. We conclude that bubble oxygenator are capable to induce microembolisms in a high percentage of the cases studied. Components of the microemboli are cytotoxic. Therefore microembolisms could be participating in the morbidity of patients subjects to cardiopulmonary bypass.

Cytomorphological comparison of mechanical and chemical defoaming of a yeast culture.

Defoaming of the medium by a rotating turbine during yeast cultivation, in contrast to defoaming by oil, results in fading away of cells of higher age categories and in an increase of dead cells proportion in the population. The negative effect of the mechanical defoaming device did not manifest itself in the amount of biomass obtained but in the cell numbers observed.

Foam suppression in overloaded manure-based biogas reactors using antifoaming agents.

Foam control is an imperative need in biogas plants, as foaming is a major operational problem. In the present study, the effect of oils (rapeseed oil, oleic acid, and octanoic acid) and tributylphosphate on foam reduction and process performance in batch and continuous manure-based biogas reactors was investigated. The compounds were tested in dosages of 0.05%, 0.1% and 0.5% v/vfeed. The results showed that rapeseed oil was most efficient to suppress foam at the dosage of 0.05% and 0.1% v/vfeed, while octanoic acid was most efficient to suppress foam at dosage of 0.5% v/vfeed. Moreover, the addition of rapeseed oil also increased methane yield. In contrast, tributylphosphate, which was very efficient antifoam, was found to be inhibitory to the biogas process.

The effect of antifoam addition on protein production yields.

Pichia pastoris is a widely used host for recombinant protein production. The foaming associated with culturing it on a large scale is commonly prevented by the addition of chemical antifoaming agents or "antifoams." Unexpectedly, the addition of a range of antifoams to both shake flask and bioreactor cultures of P. pastoris has been shown to alter the total yield of the recombinant protein being produced. Possible explanations for this are that the presence of the antifoam increases the total amount of protein being produced and secreted per cell or that it increases the density of the culture. Antifoaming agents may therefore have specific effects on the growth and yield characteristics of recombinant cultures, in addition to their primary action as de-foamers.

Drug interaction of levothyroxine with infant colic drops.

Infacol (Forest Laboratories UK, Kent, UK) is a widely available over-the-counter preparation used to relieve colic symptoms in neonates and infants. The active ingredient is simeticone. No drug interactions with simeticone are documented in the current summary of product characteristics. The authors report the case of an infant with confirmed congenital hypothyroidism on levothyroxine who experienced a possible drug interaction with simeticone. Despite adequate levothyroxine dosage, thyroid stimulating hormone (TSH) was high, suggesting undertreatment. Questioning revealed the child was taking Infacol drops before feeds while on levothyroxine. The colic drops were immediately discontinued and TSH promptly normalised with a reduction in thyroxine requirement to an age appropriate dosage. Drug interaction of thyroxine with simeticone has not been reported previously and is not listed in the British National Formulary for Children. Clinicians and parents need to be aware of this interaction to avoid unnecessary undertreatment and prevent potential long-term neurological sequelae.