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W1770 Reduction of Gut-Caused Halitosis with Probiotic E. coli Nissle 1917 - First Findings
the timing of application of probiotics is a pivotal factor for their beneficial effects on the ileal barrier.
W1772 Use of Vsl#3® (a New High Concentration Probiotic Mixture) in the Treatment of Childhood Diarrhea with Specific Reference to Rotavirus Diarrhea Anand P. Dubey, Rajeshwari Krishnan, Anita Chakravarti, Arun Aggarwal, Brij K. Atal, Claudio De Simone, Vandana Pandey, Aditya R. Sahu
AGA Abstracts
W1770 Reduction of Gut-Caused Halitosis with Probiotic E. coli Nissle 1917 - First Findings Simon Straub, Katrin Andraczek, Corinna Wolff, Jobst Henker
There is some suggestion that use of probiotics may shorten the clinical course and consequent morbidity of rotaviral diarrhoea. We designed a randomized, double-blind, placebo-controlled trial to test the efficacy and tolerability of an innovative high-concentration probiotic mixture (VSL#3) for the treatment of acute rotavirus-associated diarrhea in children aged 6 months to 2 years. VSL#3 contained 4 strains of Lactobacilli, 3 strains of Bifidobacteria and 1 strain of S.thermophilus (90 billion lyophilized bacteria/ sachet). VSL#3 was given at doses of 2/4/6 sachets/day for children with weight <5Kg, 5-10Kg or >10Kg, respectively. Participants were randomly assigned to receive either the placebo (n=111) or VSL#3 (n= 113) for 4 days. All participants were hospitalized during the whole period of trial. The primary efficacy variables evaluated in the study were the number of stools per day (frequency of loose stools) and the total duration of diarrhea expressed in hours (diarrhea ended at the first soft stool). At recruitment on Day 1 there were no significant differences between the two groups in terms of mean loose stool frequency, stool consistency, mean frequency of vomiting and of ORS administration. The frequency of intravenous fluids administered was significantly less in the VSL#3 group (VSL#3 838.08 ± 470.43 vs placebo 1009.84 ± 522.03, p 0.027). On Day 2 a lower mean stool frequency (VSL#3 8.18 ± 5.265 vs placebo 10.8 ± 6.12) and improved stool consistency was noted in VSL#3 group (p<0.001 and p<0.05 respectively). This was also reflected in the lower volume of ORS administration (VSL#3 300.18 ± 222.80 vs placebo 454.59 ± 278.00, p<0.001). On Day 3 mean loose stool frequency (p<0.001), frequency of ORS use (p<0.001) and frequency of intravenous fluid use (p 0.043) was significantly lower in VSL#3 group. The differences in the frequency of loose stools persisted till 8 hours of Day 4 (p 0.001). The overall loose stool frequency and ORS requirement on day 4 was significantly less in VSL#3 group (p<0.001 and p<0.001 respectively). The overall duration of diarrhea in the VSL#3 group was 50.25 ± 14.35 hours vs 63.74 ± 13.72 hours (p<0.001).The overall recovery rates were significantly better in VSL#3 group compared to placebo (p<0.001). No side effects were noted with the use of the probiotic mixture. This is the largest systematic trial evaluating the efficacy of probiotic therapy in children with rotaviral diarrhea. Our results indicate that treatment with the probiotic preparation VSL#3 could be a valuable tool for the treatment of this severe and potentially lethal viral diarrhea in children.
Introduction: Bad breath is a widely spread problem and may lead to reduced self-confidence and social problems in affected individuals. Up to 50% of US-american population suffer from oral malodor, up to half of this population experience severe discomfort. In about 10% of cases, bad breath is not of oral origin. Volatile compounds produced by bacterial processes in the bowel and transported by blood to the lung or the oral glands may also be responsible for halitosis. Aims & Methods: This pilot-study aims to investigate the effect of the probiotic Escherichia coli Nissle 1917 (EcN) on gut-caused halitosis in healthy subjects with no significant dental report. Two adolescents at the age of 12 and 17 years and five adults with oral malodour received two capsules EcN (Mutaflor®; Ardeypharm GmbH, Herdecke, Germany) per day, each containing 2.5-25 x 10E9 colony forming units over a period of 28 days. A questionnaire was filled out by volunteers before and after treatment. Mouth breath was consequently assessed organoleptically using a 0-to-5-scale (from 0 = no odor detectable to 5 = extremely strong odor). In addition, exhaled air and tongue smear of the volunteers were analyzed with high sensitive GC/MS-analysis (gas chromatography/ mass spectrometry) including chemical ionisation (GC Varian Star 3400, MS Varian Saturn 2000). Results: Scores produced by organoleptic assessment reaching 3 to 4 before treatment were consistently reduced to 0 to 2. In each sample (exhaled air and tongue smear) over 150 compounds were detected by GC/MS-analysis. Indole, a compound with proven importance in oral malodour, and Phenol were found consistently in remarkably high levels. Following the four week intake of probiotic these compounds were considerably diminished in tongue smear specimen. Indole showed a reduction ranging between 81.9% and 99.9%. Phenol-values were also noticeably reduced (median 79.6%, minimum 24.5%, maximum 99.7%). Conclusion: EcN seems to reduce the symptoms of halitosis in seven dentally healthy individuals according to organoleptic procedure and GC/MS analysis. These data confirm the findings of a former case report of a 9-year-old girl with gut-caused halitosis. A randomized double-blind placebo-controlled study should be initiated, in order to prove our hypothesis in a larger population. References: McKeown L. Int J Dent Hyg 2003;1(4):213-7. Bosy A. J Can Dent Assoc 1997;63(3):196-201. Tessier JF, Kulkarni GV. Oral Health 1991;81(10):19-22. Porter SR, Scully C. Bmj 2006;333(7569):632-5. Greenman J, El-Maaytah M, Duffield J, et al. J Am Dent Assoc 2005;136(6):749-57. Henker J, Schuster F, Nissler K. Eur J Pediatr 2001;160(10):592-4.
W1773 A Randomized Trial Evaluating Probiotic Preparation Vsl#3 Versus Oral mesalamine in Patients with Active Microscopic Colitis Sarika Rohatgi, Vineet Ahuja, Govind K. Makharia, Claudio De Simone, Aditya R. Sahu
W1771 Effect of Eight Weeks of Treatment with Probiotic Yoghurt On Irritable Bowel Syndrome Symptoms - a Randomized, Double-Blind, Placebo-Controlled Trial Bo Sondergaard, Rickard W. Ekesbo, Johan Olsson, Kajsa Ohlson, Ulla K. Svensson, Peter Bytzer
Introduction: Microscopic colitis is a chronic inflammatory condition causing large bowel diarrhea. No specific treatment is available for this disease. Aim: To assess the clinical efficacy of a probiotic preparation VSL#3 in the treatment of active microscopic colitis. Methods: A randomized open labeled trial comparing VSL#3 with mesalamine in assessing the clinical response in patients with active microscopic colitis. The inclusion criteria were biopsy proven adult cases of microscopic colitis with activity as defined by stool frequency > 3/day , a stool consistency score > 3 and a diarrhea severity score >1 averaged over the week prior to enrollment in the study. The patients were randomised to receive either 2 sachets of VSL#3 (450 Billion CFU) or 1.6g of mesalamine/day for a period of 8 weeks. The outcome variables assessed were: stool frequency, stool weight, stool consistency, diarrheal rate, abdominal pain, presence of mucus, and well being. Likert methods of summed ratings was used to grade mucus secretion and general well being. Results: An interim analysis at the end of 8 weeks included 17 patients (male 12, female 5), 10 in mesalamine and 7 in VSL#3 group. The mean age of the patients was 41.8±13 years. VSL#3 therapy resulted in a significant reduction in stool weight (baseline vs 8 weeks: 492 ± 127 vs 427 ± 87 gms, p= 0.04), presence of mucus (2.7 ± 1.3 vs 1.2 ± 0.7, p=0.02) and wellbeing (3.5 ± 0.9 vs 2.4 ± 0.5, p=0.03). There was a trend towards improvement in diarrheal rate (1.2 ± 0.4 vs 0.8 ± 0.3, p=0.08). There was no significant change in stool frequency, stool consistency, abdominal pain, ESR, C-reactive protein and platelet levels. Mesalamine therapy resulted in a significant reduction in stool consistency (3.9 ± 0.5 vs 3.3 ± 0.4, p=0.01), presence of mucus (2.9 ± 1.3 vs 1.9 ± 0.7, p=0.04) and wellbeing (3.9 ± 0.3 vs 3 ± 0.8, p=0.03). There was no significant change in stool frequency, stool weight, diarrheal rate, abdominal pain, ESR, C reactive protein and platelet levels. Both the therapies were comparable in all outcome variables except that VSL#3 was superior to mesalamine in decreasing stool weight at 8 weeks ( 427 ± 87 vs 571 ± 132 gms, p=0.04). Conclusion: In microscopic colitis, VSL#3 significantly improves stool weight, stool mucus, and general well being. Mesalamine significantly improves stool consistency, stool mucus and general well being. VSL#3 achieves a better reduction in stool weight as compared to mesalamine.
The treatment of irritable bowel syndrome (IBS) remains unsatisfactory. The effect of probiotics on IBS symptoms has been mixed, but remains an intriguing treatment option with appeal to the patient. Aims & Methods: We aimed to investigate the effect of eight weeks of treatment with yoghurt containing probiotics compared to a control group receiving acidified milk. Patients fulfilling the Rome II criteria, who reported inadequate relief of symptoms during a 2 week run-in period, were randomized double-blind to a daily intake of 500 ml of yoghurt containing at least 5 X 107 cfu/ml of Lactobacillus paracasei, ssp. paracasei, Lactobacillus acidophilus and Bifidobacterium lactis or an equal volume of acidified milk. The products were comparable in colour, smell, flavour and texture. Symptoms were assessed at baseline and weekly using a disease specific validated symptom rating scale (IBSSSI) and by daily registration of the number of bowel movements, stool consistency using the Bristol Stool Scale Form (BSF) and GI symptoms (pain, bloating, flatulence) using a 4 point Likert scale. The predefined primary outcome measure was patient reported adequate symptom relief. Quality of life was assessed at baseline and at the end of the treatment period using both a disease specific scale (IBSQOL), a generic scale (SF-36) and by use of the Hospital Anxiety and Depression scale. Use of antibiotics and additional probiotics were prohibited during the study period. Adherence to study protocol were assessed by performing stool samples at baseline and at the of the treatment period. Results: 84 patients were screened. 70 patients were randomized - 18 patients did not complete the study due to protocol violations or withdrew due to lack of effect. 52 patients (13 males) completed the study; mean age was 51.3 years (range 29 - 67). The proportion of patients reporting adequate symptom relief increased in both patient groups, but there was not any statistical difference between the groups. IBS-SSI scores and quality of life measurements did not differ statistically between the groups at the end of the treatment period, but improved during the study period in both groups. In an exploratory post-hoc analysis the symptom score for flatulence decreased significantly in the active group in the first two weeks of the treatment period, but the effect was not sustained. Conclusion: During this eight week trial gastrointestinal symptoms and quality of life improved. However, there was no difference between treatment with yoghurt containing probiotics or acidified milk. The effect of probiotics on IBS symptoms remains uncertain and further studies are warranted.
W1774 Bifidobacterium Bifidum Improves Intestinal Barrier Function in Experimental Necrotizing Enterocolitis Ludmila Khailova, Andrew Maynard, Katerina Dvorak, Kelly M. Arganbright, Melissa Halpern, Toshi Kinouchi, Masako Yajima, Bohuslav Dvorak Background: Neonatal necrotizing enterocolitis (NEC) is a major cause of morbidity and mortality in premature infants. Intestinal barrier integrity is regulated by a number of factors, including mucus secretion and tight junction structure. Previously, we have shown that neonatal rats with NEC have increased intestinal paracellular permeability, decreased ileal goblet cell density, reduced ileal mucin production, and disturbed tight junctions structure compared to healthy controls. Oral administration of probiotics has been suggested as a promising strategy for prevention of NEC. However, little is known about the mechanism(s) of probiotic-mediated protection against NEC. Objective: The aim of this study was to
AGA Abstracts
A-712
W1772 Use of Vsl#3® (a New High Concentration Probiotic Mixture) in the Treatment of Childhood Diarrhea with Specific Reference to Rotavirus Diarrhea Anand P. Dubey, Rajeshwari Krishnan, Anita Chakravarti, Arun Aggarwal, Brij K. Atal, Claudio De Simone, Vandana Pandey, Aditya R. Sahu
AGA Abstracts
W1770 Reduction of Gut-Caused Halitosis with Probiotic E. coli Nissle 1917 - First Findings Simon Straub, Katrin Andraczek, Corinna Wolff, Jobst Henker
There is some suggestion that use of probiotics may shorten the clinical course and consequent morbidity of rotaviral diarrhoea. We designed a randomized, double-blind, placebo-controlled trial to test the efficacy and tolerability of an innovative high-concentration probiotic mixture (VSL#3) for the treatment of acute rotavirus-associated diarrhea in children aged 6 months to 2 years. VSL#3 contained 4 strains of Lactobacilli, 3 strains of Bifidobacteria and 1 strain of S.thermophilus (90 billion lyophilized bacteria/ sachet). VSL#3 was given at doses of 2/4/6 sachets/day for children with weight <5Kg, 5-10Kg or >10Kg, respectively. Participants were randomly assigned to receive either the placebo (n=111) or VSL#3 (n= 113) for 4 days. All participants were hospitalized during the whole period of trial. The primary efficacy variables evaluated in the study were the number of stools per day (frequency of loose stools) and the total duration of diarrhea expressed in hours (diarrhea ended at the first soft stool). At recruitment on Day 1 there were no significant differences between the two groups in terms of mean loose stool frequency, stool consistency, mean frequency of vomiting and of ORS administration. The frequency of intravenous fluids administered was significantly less in the VSL#3 group (VSL#3 838.08 ± 470.43 vs placebo 1009.84 ± 522.03, p 0.027). On Day 2 a lower mean stool frequency (VSL#3 8.18 ± 5.265 vs placebo 10.8 ± 6.12) and improved stool consistency was noted in VSL#3 group (p<0.001 and p<0.05 respectively). This was also reflected in the lower volume of ORS administration (VSL#3 300.18 ± 222.80 vs placebo 454.59 ± 278.00, p<0.001). On Day 3 mean loose stool frequency (p<0.001), frequency of ORS use (p<0.001) and frequency of intravenous fluid use (p 0.043) was significantly lower in VSL#3 group. The differences in the frequency of loose stools persisted till 8 hours of Day 4 (p 0.001). The overall loose stool frequency and ORS requirement on day 4 was significantly less in VSL#3 group (p<0.001 and p<0.001 respectively). The overall duration of diarrhea in the VSL#3 group was 50.25 ± 14.35 hours vs 63.74 ± 13.72 hours (p<0.001).The overall recovery rates were significantly better in VSL#3 group compared to placebo (p<0.001). No side effects were noted with the use of the probiotic mixture. This is the largest systematic trial evaluating the efficacy of probiotic therapy in children with rotaviral diarrhea. Our results indicate that treatment with the probiotic preparation VSL#3 could be a valuable tool for the treatment of this severe and potentially lethal viral diarrhea in children.
Introduction: Bad breath is a widely spread problem and may lead to reduced self-confidence and social problems in affected individuals. Up to 50% of US-american population suffer from oral malodor, up to half of this population experience severe discomfort. In about 10% of cases, bad breath is not of oral origin. Volatile compounds produced by bacterial processes in the bowel and transported by blood to the lung or the oral glands may also be responsible for halitosis. Aims & Methods: This pilot-study aims to investigate the effect of the probiotic Escherichia coli Nissle 1917 (EcN) on gut-caused halitosis in healthy subjects with no significant dental report. Two adolescents at the age of 12 and 17 years and five adults with oral malodour received two capsules EcN (Mutaflor®; Ardeypharm GmbH, Herdecke, Germany) per day, each containing 2.5-25 x 10E9 colony forming units over a period of 28 days. A questionnaire was filled out by volunteers before and after treatment. Mouth breath was consequently assessed organoleptically using a 0-to-5-scale (from 0 = no odor detectable to 5 = extremely strong odor). In addition, exhaled air and tongue smear of the volunteers were analyzed with high sensitive GC/MS-analysis (gas chromatography/ mass spectrometry) including chemical ionisation (GC Varian Star 3400, MS Varian Saturn 2000). Results: Scores produced by organoleptic assessment reaching 3 to 4 before treatment were consistently reduced to 0 to 2. In each sample (exhaled air and tongue smear) over 150 compounds were detected by GC/MS-analysis. Indole, a compound with proven importance in oral malodour, and Phenol were found consistently in remarkably high levels. Following the four week intake of probiotic these compounds were considerably diminished in tongue smear specimen. Indole showed a reduction ranging between 81.9% and 99.9%. Phenol-values were also noticeably reduced (median 79.6%, minimum 24.5%, maximum 99.7%). Conclusion: EcN seems to reduce the symptoms of halitosis in seven dentally healthy individuals according to organoleptic procedure and GC/MS analysis. These data confirm the findings of a former case report of a 9-year-old girl with gut-caused halitosis. A randomized double-blind placebo-controlled study should be initiated, in order to prove our hypothesis in a larger population. References: McKeown L. Int J Dent Hyg 2003;1(4):213-7. Bosy A. J Can Dent Assoc 1997;63(3):196-201. Tessier JF, Kulkarni GV. Oral Health 1991;81(10):19-22. Porter SR, Scully C. Bmj 2006;333(7569):632-5. Greenman J, El-Maaytah M, Duffield J, et al. J Am Dent Assoc 2005;136(6):749-57. Henker J, Schuster F, Nissler K. Eur J Pediatr 2001;160(10):592-4.
W1773 A Randomized Trial Evaluating Probiotic Preparation Vsl#3 Versus Oral mesalamine in Patients with Active Microscopic Colitis Sarika Rohatgi, Vineet Ahuja, Govind K. Makharia, Claudio De Simone, Aditya R. Sahu
W1771 Effect of Eight Weeks of Treatment with Probiotic Yoghurt On Irritable Bowel Syndrome Symptoms - a Randomized, Double-Blind, Placebo-Controlled Trial Bo Sondergaard, Rickard W. Ekesbo, Johan Olsson, Kajsa Ohlson, Ulla K. Svensson, Peter Bytzer
Introduction: Microscopic colitis is a chronic inflammatory condition causing large bowel diarrhea. No specific treatment is available for this disease. Aim: To assess the clinical efficacy of a probiotic preparation VSL#3 in the treatment of active microscopic colitis. Methods: A randomized open labeled trial comparing VSL#3 with mesalamine in assessing the clinical response in patients with active microscopic colitis. The inclusion criteria were biopsy proven adult cases of microscopic colitis with activity as defined by stool frequency > 3/day , a stool consistency score > 3 and a diarrhea severity score >1 averaged over the week prior to enrollment in the study. The patients were randomised to receive either 2 sachets of VSL#3 (450 Billion CFU) or 1.6g of mesalamine/day for a period of 8 weeks. The outcome variables assessed were: stool frequency, stool weight, stool consistency, diarrheal rate, abdominal pain, presence of mucus, and well being. Likert methods of summed ratings was used to grade mucus secretion and general well being. Results: An interim analysis at the end of 8 weeks included 17 patients (male 12, female 5), 10 in mesalamine and 7 in VSL#3 group. The mean age of the patients was 41.8±13 years. VSL#3 therapy resulted in a significant reduction in stool weight (baseline vs 8 weeks: 492 ± 127 vs 427 ± 87 gms, p= 0.04), presence of mucus (2.7 ± 1.3 vs 1.2 ± 0.7, p=0.02) and wellbeing (3.5 ± 0.9 vs 2.4 ± 0.5, p=0.03). There was a trend towards improvement in diarrheal rate (1.2 ± 0.4 vs 0.8 ± 0.3, p=0.08). There was no significant change in stool frequency, stool consistency, abdominal pain, ESR, C-reactive protein and platelet levels. Mesalamine therapy resulted in a significant reduction in stool consistency (3.9 ± 0.5 vs 3.3 ± 0.4, p=0.01), presence of mucus (2.9 ± 1.3 vs 1.9 ± 0.7, p=0.04) and wellbeing (3.9 ± 0.3 vs 3 ± 0.8, p=0.03). There was no significant change in stool frequency, stool weight, diarrheal rate, abdominal pain, ESR, C reactive protein and platelet levels. Both the therapies were comparable in all outcome variables except that VSL#3 was superior to mesalamine in decreasing stool weight at 8 weeks ( 427 ± 87 vs 571 ± 132 gms, p=0.04). Conclusion: In microscopic colitis, VSL#3 significantly improves stool weight, stool mucus, and general well being. Mesalamine significantly improves stool consistency, stool mucus and general well being. VSL#3 achieves a better reduction in stool weight as compared to mesalamine.
The treatment of irritable bowel syndrome (IBS) remains unsatisfactory. The effect of probiotics on IBS symptoms has been mixed, but remains an intriguing treatment option with appeal to the patient. Aims & Methods: We aimed to investigate the effect of eight weeks of treatment with yoghurt containing probiotics compared to a control group receiving acidified milk. Patients fulfilling the Rome II criteria, who reported inadequate relief of symptoms during a 2 week run-in period, were randomized double-blind to a daily intake of 500 ml of yoghurt containing at least 5 X 107 cfu/ml of Lactobacillus paracasei, ssp. paracasei, Lactobacillus acidophilus and Bifidobacterium lactis or an equal volume of acidified milk. The products were comparable in colour, smell, flavour and texture. Symptoms were assessed at baseline and weekly using a disease specific validated symptom rating scale (IBSSSI) and by daily registration of the number of bowel movements, stool consistency using the Bristol Stool Scale Form (BSF) and GI symptoms (pain, bloating, flatulence) using a 4 point Likert scale. The predefined primary outcome measure was patient reported adequate symptom relief. Quality of life was assessed at baseline and at the end of the treatment period using both a disease specific scale (IBSQOL), a generic scale (SF-36) and by use of the Hospital Anxiety and Depression scale. Use of antibiotics and additional probiotics were prohibited during the study period. Adherence to study protocol were assessed by performing stool samples at baseline and at the of the treatment period. Results: 84 patients were screened. 70 patients were randomized - 18 patients did not complete the study due to protocol violations or withdrew due to lack of effect. 52 patients (13 males) completed the study; mean age was 51.3 years (range 29 - 67). The proportion of patients reporting adequate symptom relief increased in both patient groups, but there was not any statistical difference between the groups. IBS-SSI scores and quality of life measurements did not differ statistically between the groups at the end of the treatment period, but improved during the study period in both groups. In an exploratory post-hoc analysis the symptom score for flatulence decreased significantly in the active group in the first two weeks of the treatment period, but the effect was not sustained. Conclusion: During this eight week trial gastrointestinal symptoms and quality of life improved. However, there was no difference between treatment with yoghurt containing probiotics or acidified milk. The effect of probiotics on IBS symptoms remains uncertain and further studies are warranted.
W1774 Bifidobacterium Bifidum Improves Intestinal Barrier Function in Experimental Necrotizing Enterocolitis Ludmila Khailova, Andrew Maynard, Katerina Dvorak, Kelly M. Arganbright, Melissa Halpern, Toshi Kinouchi, Masako Yajima, Bohuslav Dvorak Background: Neonatal necrotizing enterocolitis (NEC) is a major cause of morbidity and mortality in premature infants. Intestinal barrier integrity is regulated by a number of factors, including mucus secretion and tight junction structure. Previously, we have shown that neonatal rats with NEC have increased intestinal paracellular permeability, decreased ileal goblet cell density, reduced ileal mucin production, and disturbed tight junctions structure compared to healthy controls. Oral administration of probiotics has been suggested as a promising strategy for prevention of NEC. However, little is known about the mechanism(s) of probiotic-mediated protection against NEC. Objective: The aim of this study was to
AGA Abstracts
A-712