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P.07.14 EFFICACY AND TOLERABILITY OF A-GALACTOSIDASE ON GAS RELATED SYMPTOMS IN PEDIATRIC IRRITABLE BOWEL SYNDROME. A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL
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Abstracts of the 18th National Congress of Digestive Diseases / Digestive and Liver Disease 44S (2012) S55–S220
P.07.14 EFFICACY AND TOLERABILITY OF A-GALACTOSIDASE ON GAS RELATED SYMPTOMS IN PEDIATRIC IRRITABLE BOWEL SYNDROME. A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL G. Di Nardo ∗ ,1 , S. Mallardo 1 , S. Oliva 1 , C. Cremon 2 , P. Rossi 1 , F. Ferrari 1 , M. Aloi 1 , G. Pagliaro 1 , S. Cucchiara 1 1 Pediatric Gastroenterology and Liver Unit, Sapienza – University of Rome, Roma, Italy; 2 Department of Medical Science, University of Bologna, Bologna, Italy
Background and aim: Bloating, abdominal distension and flatulence represent very frequent complaints in children with irritable bowel syndrome (IBS).These symptoms are frequently associated to excessive intestinal gas. a-Galactosidase has been shown to reduce gas production and related symptoms in adults. Aim of the study is to evaluate the efficacy and tolerability of a-galactosidase on gas related symptoms in pediatric IBS patients. Material and methods: This was a single center, randomized, double-blind, placebo-controlled, parallel-group study performed in tertiary care setting. Fifty-two pediatric patients (32 female, median age 8 yrs, range 4-17)with IBS according to Rome III criteria were randomized to receive placebo (n=25) or a-galactosidase (n=27) (Sinaire, Promefarm).Both treatments were given as drops or tablets according to body weight at the beginning of each of three meals for 2 weeks. Children were followed up two weeks after the end of treatment. Parent and/or self-assessment of the severity of gas related symptoms (bloating, flatulence, abdominal distension and abdominal spasms) were recorded 3 times daily during the treatment period using a validated visual score. The primary endpoint was reduction in the severity of bloating at the end of treatment compared to baseline. Secondary endpoints were reduction in the severity of other symptoms. As a measure of intestinal gas production, breath hydrogen concentration was measured at baseline and at the end of treatment. Results: a-galactosidase significantly reduced the severity of bloating (p=0,023) and flatulence (p=0,005) as compared with placebo.No significant differences were found for abdominal spasms and abdominal distension. The administration of a-galactosidase had no significant effect on breath hydrogen excretion as compared with placebo (p=0,54). The benefical effects of treatment tended to disappear in both groups at the end of follow-up. No adverse events were reported during treatment. Conclusions: Although larger and longer trials are needed to confirm our results, a-galattosidase looks a safe and effective agent for managing gas related symptoms in pediatric IBS.
P.07.15 EFFECTS OF THERMAL COOLING ON HUMAN COLONIC SMOOTH MUSCLE CONTRACTILITY A. Altomare ∗ ,1 , M.P.L. Guarino 1 , A. Gizzi 2 , S. Cocca 1 , C. Cherubini 2 , R. Alloni 1 , S. Filippi 2 , M. Cicala 1 1 Dept
of Digestive Diseases, Campus Bio-Medico University, Rome, Italy; Physics and Mathematical Modeling Laboratory, Campus Bio-Medico University, Rome, Italy 2 Nonlinear
Background and aim: Paralytic ileus is a frequent complication of major abdominal surgery, but the exact mechanism is unknown. Recent studies based on physiologically tuned mathematical models predict that thermal inhomogeneity operating theatre environment may induce an electrochemical destabilization of the peristaltic activity. Material and methods: HCCMSs were obtained from disease-free margins of resected segments for cancer. After removing the mucosa and serosa layers, strips were mounted in separate chambers. After 30 min spontaneous contractions gradually developed. Isometric contractions were measured using force displacement transducers connected with a computer. Temperature was decreased every 45 min (from 37°C to 36°C and to 35°C). Temperature values were established on the basis of intra-operative colonic temperature measurements during surgery. The effect of cooling was analyzed on mean contractile amplitude and on contraction to Acetylcholine (Ach 10-5M).
Results: At 37°C HCCMSs developed a stable phasic contraction with a significant Ach-elicited contractile response (39% vs baseline). Lowering thermal bath temperature higher mean contractile amplitude was observed, being 20 and 19% increased at 36°C and 35°C respectively (vs 37°C mean percentage of contraction). By decreasing temperature, response to Ach increased, being 40% at 36°C and 46% at 35°C. By setting the temperature at the initial value (37°C), mean percentage of contraction and Ach response remained higher during the entire 30min period of observation. A preliminary theoretical model has shown that thermal cooling leads the transmembrane potential to change its period as well as its duration and amplitude. Conclusions: Acute thermal cooling affects colonic muscular function by increasing basal tone and response to cholinergic stimulus. These effects are not reversible after short-term observation. It is known that temperature affects the ionic conductances and the rate constants modulating the action potential propagation in giant squid axon. We hypothesize that temperature gradients, by changing the ion dynamics, could influence the electrochemical behaviour of intestinal muscle, with a memory effect which should require time to be deleted. Further studies are needed to establish the exact involved mechanisms in order to understand clinical consequences of hypothermia during abdominal surgery.
P.07.16 BACTERIAL OVERGROWTH IN IRRITABLE BOWEL SYNDROME: A COHORT STUDY A. Bertelè ∗ , C. Papadia, S. Bosi, F. Marcucci, V. Corrente, A. Ciarleglio, A. Franzè Parma University Hospital, Parma, Italy Background and aim: Small intestinal bacterial overgrowth (SIBO) has been proposed as an etiologic factor in irritable bowel syndrome (IBS), but evidence is conflicting. There are few data available concerning the prevalence of small intestinal bacterial overgrowth in northern Italian patients with irritable bowel syndrome. This study evaluated the prevalence of small intestinal bacterial overgrowth in patients with irritable bowel syndrome compared with healthy controls. Material and methods: This study included 150 consecutive patients with irritable bowel syndrome (n=38 diarrhoea predominant; n=52 constipation predominant; n=60 mixed type) between the ages 18 and 65 years and 102 controls, attending the gastroenterology clinics of a northern Italy tertiary care centre. Diagnosis of irritable bowel syndrome was made according to the Rome III criteria. Small intestinal bacterial overgrowth was estimated by using the non-invasive glucose hydrogen breath test. Results: Of 150 patients with irritable bowel syndrome, 36 (24%) were male and 114 (76%) were female. Of 102 controls, 32 (31%) were male and 71 (69%) female. The prevalence of small intestinal bacterial overgrowth was 57 (38%) patients with irritable bowel syndrome and 11 (11%) in apparently healthy controls. This difference was statistically significant. The prevalence of small intestinal bacterial overgrowth in male and female patients was not significantly different. Conclusions: This study indicates that the prevalence of small intestinal bacterial overgrowth in irritable bowel syndrome patients from Northern Italy is 38%, which is increased than the previously reported prevalence.
P.07.17 DIAGNOSTIC VALUE OF BOWEL ULTRASONOGRAPHY FOR IDENTIFYING PATIENTS WITH IRRITABLE BOWEL SYNDROME G. Maconi ∗ , C. Bezzio, E. Bolzacchini, F. Furfaro, R. De Franchis Gastrointestinal Unit - Luigi Sacco University Hospital, Milan, Italy Background and aim: Irritable bowel syndrome (IBS) is a frequent disorder without specific diagnostic tests. Ultrasonographic (US) assessment of the thickness of muscolaris propria (MP) of sigmoid colon has been suggested to identify IBS patients. The study assessed whether: a) US measurements of the thickness of MP of sigma, and b) pain evoked by US guided compression of sigma, can identify IBS-patients.
Abstracts of the 18th National Congress of Digestive Diseases / Digestive and Liver Disease 44S (2012) S55–S220
P.07.14 EFFICACY AND TOLERABILITY OF A-GALACTOSIDASE ON GAS RELATED SYMPTOMS IN PEDIATRIC IRRITABLE BOWEL SYNDROME. A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL G. Di Nardo ∗ ,1 , S. Mallardo 1 , S. Oliva 1 , C. Cremon 2 , P. Rossi 1 , F. Ferrari 1 , M. Aloi 1 , G. Pagliaro 1 , S. Cucchiara 1 1 Pediatric Gastroenterology and Liver Unit, Sapienza – University of Rome, Roma, Italy; 2 Department of Medical Science, University of Bologna, Bologna, Italy
Background and aim: Bloating, abdominal distension and flatulence represent very frequent complaints in children with irritable bowel syndrome (IBS).These symptoms are frequently associated to excessive intestinal gas. a-Galactosidase has been shown to reduce gas production and related symptoms in adults. Aim of the study is to evaluate the efficacy and tolerability of a-galactosidase on gas related symptoms in pediatric IBS patients. Material and methods: This was a single center, randomized, double-blind, placebo-controlled, parallel-group study performed in tertiary care setting. Fifty-two pediatric patients (32 female, median age 8 yrs, range 4-17)with IBS according to Rome III criteria were randomized to receive placebo (n=25) or a-galactosidase (n=27) (Sinaire, Promefarm).Both treatments were given as drops or tablets according to body weight at the beginning of each of three meals for 2 weeks. Children were followed up two weeks after the end of treatment. Parent and/or self-assessment of the severity of gas related symptoms (bloating, flatulence, abdominal distension and abdominal spasms) were recorded 3 times daily during the treatment period using a validated visual score. The primary endpoint was reduction in the severity of bloating at the end of treatment compared to baseline. Secondary endpoints were reduction in the severity of other symptoms. As a measure of intestinal gas production, breath hydrogen concentration was measured at baseline and at the end of treatment. Results: a-galactosidase significantly reduced the severity of bloating (p=0,023) and flatulence (p=0,005) as compared with placebo.No significant differences were found for abdominal spasms and abdominal distension. The administration of a-galactosidase had no significant effect on breath hydrogen excretion as compared with placebo (p=0,54). The benefical effects of treatment tended to disappear in both groups at the end of follow-up. No adverse events were reported during treatment. Conclusions: Although larger and longer trials are needed to confirm our results, a-galattosidase looks a safe and effective agent for managing gas related symptoms in pediatric IBS.
P.07.15 EFFECTS OF THERMAL COOLING ON HUMAN COLONIC SMOOTH MUSCLE CONTRACTILITY A. Altomare ∗ ,1 , M.P.L. Guarino 1 , A. Gizzi 2 , S. Cocca 1 , C. Cherubini 2 , R. Alloni 1 , S. Filippi 2 , M. Cicala 1 1 Dept
of Digestive Diseases, Campus Bio-Medico University, Rome, Italy; Physics and Mathematical Modeling Laboratory, Campus Bio-Medico University, Rome, Italy 2 Nonlinear
Background and aim: Paralytic ileus is a frequent complication of major abdominal surgery, but the exact mechanism is unknown. Recent studies based on physiologically tuned mathematical models predict that thermal inhomogeneity operating theatre environment may induce an electrochemical destabilization of the peristaltic activity. Material and methods: HCCMSs were obtained from disease-free margins of resected segments for cancer. After removing the mucosa and serosa layers, strips were mounted in separate chambers. After 30 min spontaneous contractions gradually developed. Isometric contractions were measured using force displacement transducers connected with a computer. Temperature was decreased every 45 min (from 37°C to 36°C and to 35°C). Temperature values were established on the basis of intra-operative colonic temperature measurements during surgery. The effect of cooling was analyzed on mean contractile amplitude and on contraction to Acetylcholine (Ach 10-5M).
Results: At 37°C HCCMSs developed a stable phasic contraction with a significant Ach-elicited contractile response (39% vs baseline). Lowering thermal bath temperature higher mean contractile amplitude was observed, being 20 and 19% increased at 36°C and 35°C respectively (vs 37°C mean percentage of contraction). By decreasing temperature, response to Ach increased, being 40% at 36°C and 46% at 35°C. By setting the temperature at the initial value (37°C), mean percentage of contraction and Ach response remained higher during the entire 30min period of observation. A preliminary theoretical model has shown that thermal cooling leads the transmembrane potential to change its period as well as its duration and amplitude. Conclusions: Acute thermal cooling affects colonic muscular function by increasing basal tone and response to cholinergic stimulus. These effects are not reversible after short-term observation. It is known that temperature affects the ionic conductances and the rate constants modulating the action potential propagation in giant squid axon. We hypothesize that temperature gradients, by changing the ion dynamics, could influence the electrochemical behaviour of intestinal muscle, with a memory effect which should require time to be deleted. Further studies are needed to establish the exact involved mechanisms in order to understand clinical consequences of hypothermia during abdominal surgery.
P.07.16 BACTERIAL OVERGROWTH IN IRRITABLE BOWEL SYNDROME: A COHORT STUDY A. Bertelè ∗ , C. Papadia, S. Bosi, F. Marcucci, V. Corrente, A. Ciarleglio, A. Franzè Parma University Hospital, Parma, Italy Background and aim: Small intestinal bacterial overgrowth (SIBO) has been proposed as an etiologic factor in irritable bowel syndrome (IBS), but evidence is conflicting. There are few data available concerning the prevalence of small intestinal bacterial overgrowth in northern Italian patients with irritable bowel syndrome. This study evaluated the prevalence of small intestinal bacterial overgrowth in patients with irritable bowel syndrome compared with healthy controls. Material and methods: This study included 150 consecutive patients with irritable bowel syndrome (n=38 diarrhoea predominant; n=52 constipation predominant; n=60 mixed type) between the ages 18 and 65 years and 102 controls, attending the gastroenterology clinics of a northern Italy tertiary care centre. Diagnosis of irritable bowel syndrome was made according to the Rome III criteria. Small intestinal bacterial overgrowth was estimated by using the non-invasive glucose hydrogen breath test. Results: Of 150 patients with irritable bowel syndrome, 36 (24%) were male and 114 (76%) were female. Of 102 controls, 32 (31%) were male and 71 (69%) female. The prevalence of small intestinal bacterial overgrowth was 57 (38%) patients with irritable bowel syndrome and 11 (11%) in apparently healthy controls. This difference was statistically significant. The prevalence of small intestinal bacterial overgrowth in male and female patients was not significantly different. Conclusions: This study indicates that the prevalence of small intestinal bacterial overgrowth in irritable bowel syndrome patients from Northern Italy is 38%, which is increased than the previously reported prevalence.
P.07.17 DIAGNOSTIC VALUE OF BOWEL ULTRASONOGRAPHY FOR IDENTIFYING PATIENTS WITH IRRITABLE BOWEL SYNDROME G. Maconi ∗ , C. Bezzio, E. Bolzacchini, F. Furfaro, R. De Franchis Gastrointestinal Unit - Luigi Sacco University Hospital, Milan, Italy Background and aim: Irritable bowel syndrome (IBS) is a frequent disorder without specific diagnostic tests. Ultrasonographic (US) assessment of the thickness of muscolaris propria (MP) of sigmoid colon has been suggested to identify IBS patients. The study assessed whether: a) US measurements of the thickness of MP of sigma, and b) pain evoked by US guided compression of sigma, can identify IBS-patients.