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156 The triangle of dysmotility: concordance of impaired gastric emptying with abnormal gallbladder emptying Angela Cole, RN 1 , Gregory Solomon, MD 1 and Philip B Miner, MD, FACG 1 *. 1 The Oklahoma Foundation for Digestive Research, Oklahoma City, OK, United States. Purpose: Poor gallbladder emptying has become a common reason for cholecystectomy. Poor emptying can be identified with a scintigraphic contrast agent that concentrates in the gallbladder. After the gallbladder has had an opportunity to fill, cholecytokinin (CCK) is given intravenously to stimulate maximal gall bladder emptying. The decrease in the counts over the gallbladder is used to calculate the Gallbladder Ejection Fraction. We have noticed persistent postoperative symptoms in many patients who undergo a cholecystectomy for poor emptying. We evaluated gastric emp- tying in 13 patients with abnormal gallbladder emptying times prior to cholecystectomy testing the hypothesis that antroduodenal dysmotility is associated with gallbladder dysmotility. Methods: Intravenous 99mTc Choletec was used to image the gallbladder and CCK IV stimulated gallbladder contraction. 99mTc sulfur colloid was mixed into a standard egg meal and ingested for the gastric emptying study. Results: 13 patients who presented with symptoms consistent with gall- bladder dysfunction were shown to have poor gallbladder ejection fractions [mean 15.7%(n 13); normal 35%]. A solid phase gastric emptying time was prolonged in 10 patients (77%) (mean 70.4 minutes (n 10); normal retained contents 60%). Conclusions: An abnormal gallbladder ejection fraction is often accom- panied by impaired gastric emptying suggesting dysmotility involves not only the gallbladder but also the stomach and duodenum forming a Triangle of Dysmotility. 157 Different probiotic supplementations for side effects prevention in a standard anti-H. pylori scheme: a randomized, double-blind, placebo-controlled study Filippo Cremonini, Simona Di Caro, Maurizio Gabrielli, Alessandro Armuzzi, Marcello Candelli, Enrico C Nista, Gianlodovico Rapaccini, Giovanni Gasbarrini and Antonio Gasbarrini*. 1 Internal Medicine, UCSC, Rome, Italy. Purpose: Probiotics may reportedly prevent side effects during anti-H.py- lori therapies, positively acting on bowel flora imbalances. We compared efficacy of two different probiotics and one probiotics combination with placebo for preventing anti-H.pylori-therapy side effects. Methods: 80 H. pylori-positive, asymptomatic patients randomized in four groups to probiotic or placebo during and for 7 days after a one-week triple therapy scheme (Omeprazole 20 mg bid, Clarythromycin 500 mg bid, Tinidazole 500 mg bid). Group 1 (n:20): Lactobacillus GG(Giflorex, Er- rekappa, Italy); group 2 (n:20): Saccharomyces boulardii (Codex, Zambon, Italy); group 3 (n:20): a combination of 10 different probiotic species (Ferzym, Specchiasol, Italy); group 4 (n:20): placebo. Subjects filled in a validated symptom diary. Blind investigators collected and calculated data. Results: Side effects occurred mainly during eradication week. In all probiotic-supplemented groups there was a significantly lower incidence of diarrhoea and taste disturbance during 1st week with respect to placebo group (Table I). Among agents used, the combination was slightly more effective with respect to side effect intensity. Conclusions: No severe side effects were overall reported. The probiotics used were all superior to placebo for side effect prevention. No withdrawal from antibiotic therapy occurred. Side effect prevalence equal among probiotic groups, but symptom intensity was lower with the combination. Side effects Lactobacillus GG Saccharomyces boulardii Combination Placebo P (Fisher’s) Diarrhoea 1/20 1/20 1/20 6/20 p 0.05 Taste disturbance 2/20 1/20 1/20 8/20 p 0.008 158 Omeprazole (Risek®) 10 mgs or 20 mgs once daily in protection of healed gastric and/or duodenal mucosa, injured previously by NSAIDs Asad I. Dojani 1 , Ali Mounis, M.D., Ph.D. 2 , Suleiman Foleil, Ph.D. 3 , Sahhar Medhat, M.D., Ph.D. 2 , Al Horaile Mehmoud, M.D., Ph.D. 4 , El Anzi Ayad, M.D. 5 , and Awad Salem, M.R.C.P. 6 1 Sharjah, VAE; 2 Cairo, Egypt; 3 Khartoum, Sudan; 4 Sanaa, Yemen; 5 Kuwait; and 6 Abu Dhabi, UAE. A comparative, endoscopically controlled, multi-center study conducted in five Arab countries was designed to establish the efficacy of two different doses of Omeprazole (10 mgs and 20 mgs) in maintaining healing of cured NSAID induced gastric and duodenal mucosal lesions. This study included 138 patients who were on continuous NSAID therapy with endoscopic evidence of gastro-duodenal ulcers or erosions. All patients received Ome- prazole 40 mgs per day for five weeks. Patients who were infected with H. pylori received Clarithromycin 500 mg and Amoxicillin 1000 mg twice daily per day in addition to the 40 mg Omeprazole during the first week of treatment. Subjects who had complete healing of their ulcers or erosions as shown by endoscopy done at the end of week 5 (n 116), were prospec- tively followed for 20 weeks. They were randomly assigned to one of two groups. One group received Omeprazole 10 mgs once daily (n 50) group A, and the other group to receive Omeprazole 20 mgs once daily (n 66) group B. The two groups were well matched in most of the key parameters of the study. Endoscopy was repeated at the last visit for all evaluable (per protocol) patients n 105. The Primary end point was maintenance of a healed gastric and/or duodenal mucosal injury. Results: Patients tolerated the medications well. In-group A patients, forty-one subjects were found to have maintained the healing and were endoscopically negative at the end of the study. Hence, maintenance of healing for ITT patients (n 50) was 82.0% (95% Confidence interval 78.42– 86.5%) and for the PP patients (N 45) the rate was 91.1%, (95% Confidence interval 86.07-95.8%). In-group B, fifty-eight subjects were found to have maintained the healing and were endoscopically negative. Therefore maintenance of healing for ITT patients (n 66) was 87.9% (95% Confidence interval 81.53-91.8%) and for the PP patients (N 60) the rate was 96.7%, (95% Confidence interval 91.14-99.89%). There was no statistical significance of the difference observed between group A and group B when comparing the ITT results (P 0.3842) or the PP results (P 0.2234). Laboratory tests for all patients indicated normal findings of all tested parameters. Adverse events were very rare for both groups. None of these events are known to be related to the study medicine Omeprazole. This study was sponsored by Gulf Pharmaceutical Industries (Julphar), UAE. 159 Gastroparesis: a risk factor for cholecystectomy? Fadi Deeb, M.D. 1 , Brian Lacy, M.D. 1 *, Hwan Yoo,M.D. 2 , Amy Mitchell, B.S. 2 and William Ravich, M.D. 2 . 1 Marvin M. Schuster Motility Center, Baltimore, MD, United States; and 2 Johns Hopkins University School of Medicine, Baltimore, MD, United States. Purpose: Over 500,000 cholecystectomies are performed each year in the US. Gallstones and acute cholecystitis are often the underlying etiology. Common symptoms in patients who undergo cholecystectomy include nausea, vomiting, and abdominal pain. Gastroparesis is a chronic disorder of delayed gastric emptying. Common etiologies include diabetes (DM), prior gastric surgery, connective tissue disorders, or a preceding viral infection. Symptoms of gastroparesis include nausea, vomiting, and ab- dominal pain. Given the similarity of symptoms in these 2 conditions we sought to determine whether patients with gastroparesis are at increased risk to undergo cholecystectomy. Aims: Determine the prevalence of cho- lecystectomy in patients with gastroparesis referred to a tertiary care center; examine whether specific etiologies of gastroparesis increase the likelihood S51 AJG – September, Suppl., 2001 Abstracts

The triangle of dysmotility: concordance of impaired gastric emptying with abnormal gallbladder emptying

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156

The triangle of dysmotility: concordance of impaired gastricemptying with abnormal gallbladder emptyingAngela Cole, RN1, Gregory Solomon, MD1 and Philip B Miner, MD,FACG1*. 1The Oklahoma Foundation for Digestive Research,Oklahoma City, OK, United States.

Purpose: Poor gallbladder emptying has become a common reason forcholecystectomy. Poor emptying can be identified with a scintigraphiccontrast agent that concentrates in the gallbladder. After the gallbladder hashad an opportunity to fill, cholecytokinin (CCK) is given intravenously tostimulate maximal gall bladder emptying. The decrease in the counts overthe gallbladder is used to calculate the Gallbladder Ejection Fraction. Wehave noticed persistent postoperative symptoms in many patients whoundergo a cholecystectomy for poor emptying. We evaluated gastric emp-tying in 13 patients with abnormal gallbladder emptying times prior tocholecystectomy testing the hypothesis that antroduodenal dysmotility isassociated with gallbladder dysmotility.Methods: Intravenous 99mTc Choletec was used to image the gallbladderand CCK IV stimulated gallbladder contraction. 99mTc sulfur colloid wasmixed into a standard egg meal and ingested for the gastric emptying study.Results: 13 patients who presented with symptoms consistent with gall-bladder dysfunction were shown to have poor gallbladder ejection fractions[mean � 15.7%(n � 13); normal � 35%]. A solid phase gastric emptyingtime was prolonged in 10 patients (77%) (mean 70.4 minutes (n � 10);normal retained contents �60%).Conclusions: An abnormal gallbladder ejection fraction is often accom-panied by impaired gastric emptying suggesting dysmotility involves notonly the gallbladder but also the stomach and duodenum forming a Triangleof Dysmotility.

157

Different probiotic supplementations for side effects prevention in astandard anti-H. pylori scheme: a randomized, double-blind,placebo-controlled studyFilippo Cremonini, Simona Di Caro, Maurizio Gabrielli, AlessandroArmuzzi, Marcello Candelli, Enrico C Nista, Gianlodovico Rapaccini,Giovanni Gasbarrini and Antonio Gasbarrini*. 1Internal Medicine,UCSC, Rome, Italy.

Purpose: Probiotics may reportedly prevent side effects during anti-H.py-lori therapies, positively acting on bowel flora imbalances. We comparedefficacy of two different probiotics and one probiotics combination withplacebo for preventing anti-H.pylori-therapy side effects.Methods: 80 H. pylori-positive, asymptomatic patients randomized in fourgroups to probiotic or placebo during and for 7 days after a one-week tripletherapy scheme (Omeprazole 20 mg bid, Clarythromycin 500 mg bid,Tinidazole 500 mg bid). Group 1 (n:20): Lactobacillus GG(Giflorex, Er-rekappa, Italy); group 2 (n:20): Saccharomyces boulardii (Codex, Zambon,Italy); group 3 (n:20): a combination of 10 different probiotic species(Ferzym, Specchiasol, Italy); group 4 (n:20): placebo. Subjects filled in avalidated symptom diary. Blind investigators collected and calculated data.Results: Side effects occurred mainly during eradication week. In allprobiotic-supplemented groups there was a significantly lower incidence ofdiarrhoea and taste disturbance during 1st week with respect to placebogroup (Table I). Among agents used, the combination was slightly moreeffective with respect to side effect intensity.Conclusions: No severe side effects were overall reported. The probioticsused were all superior to placebo for side effect prevention. No withdrawalfrom antibiotic therapy occurred. Side effect prevalence equal amongprobiotic groups, but symptom intensity was lower with the combination.

Side effectsLactobacillus

GGSaccharomyces

boulardii Combination PlaceboP

(Fisher’s)

Diarrhoea 1/20 1/20 1/20 6/20 p � 0.05Taste disturbance 2/20 1/20 1/20 8/20 p � 0.008

158

Omeprazole (Risek®) 10 mgs or 20 mgs once daily in protection ofhealed gastric and/or duodenal mucosa, injured previously byNSAIDsAsad I. Dojani1, Ali Mounis, M.D., Ph.D.2, Suleiman Foleil, Ph.D.3,Sahhar Medhat, M.D., Ph.D.2, Al Horaile Mehmoud, M.D., Ph.D.4, ElAnzi Ayad, M.D.5, and Awad Salem, M.R.C.P.6 1Sharjah, VAE; 2Cairo,Egypt; 3Khartoum, Sudan; 4Sanaa, Yemen; 5Kuwait; and 6Abu Dhabi,UAE.

A comparative, endoscopically controlled, multi-center study conducted infive Arab countries was designed to establish the efficacy of two differentdoses of Omeprazole (10 mgs and 20 mgs) in maintaining healing of curedNSAID induced gastric and duodenal mucosal lesions. This study included138 patients who were on continuous NSAID therapy with endoscopicevidence of gastro-duodenal ulcers or erosions. All patients received Ome-prazole 40 mgs per day for five weeks. Patients who were infected with H.pylori received Clarithromycin 500 mg and Amoxicillin 1000 mg twicedaily per day in addition to the 40 mg Omeprazole during the first week oftreatment. Subjects who had complete healing of their ulcers or erosions asshown by endoscopy done at the end of week 5 (n � 116), were prospec-tively followed for 20 weeks. They were randomly assigned to one of twogroups. One group received Omeprazole 10 mgs once daily (n � 50) groupA, and the other group to receive Omeprazole 20 mgs once daily (n � 66)group B. The two groups were well matched in most of the key parametersof the study. Endoscopy was repeated at the last visit for all evaluable (perprotocol) patients n � 105. The Primary end point was maintenance of ahealed gastric and/or duodenal mucosal injury.Results: Patients tolerated the medications well. In-group A patients,forty-one subjects were found to have maintained the healing and wereendoscopically negative at the end of the study. Hence, maintenance ofhealing for ITT patients (n � 50) was 82.0% (95% Confidence interval78.42–86.5%) and for the PP patients (N � 45) the rate was 91.1%, (95%Confidence interval 86.07-95.8%). In-group B, fifty-eight subjects werefound to have maintained the healing and were endoscopically negative.Therefore maintenance of healing for ITT patients (n � 66) was 87.9%(95% Confidence interval 81.53-91.8%) and for the PP patients (N � 60)the rate was 96.7%, (95% Confidence interval 91.14-99.89%). There wasno statistical significance of the difference observed between group A andgroup B when comparing the ITT results (P � 0.3842) or the PP results(P � 0.2234). Laboratory tests for all patients indicated normal findings ofall tested parameters. Adverse events were very rare for both groups. Noneof these events are known to be related to the study medicine Omeprazole.

This study was sponsored by Gulf Pharmaceutical Industries (Julphar),UAE.

159

Gastroparesis: a risk factor for cholecystectomy?Fadi Deeb, M.D.1, Brian Lacy, M.D.1*, Hwan Yoo,M.D.2, AmyMitchell, B.S.2 and William Ravich, M.D.2. 1Marvin M. SchusterMotility Center, Baltimore, MD, United States; and 2Johns HopkinsUniversity School of Medicine, Baltimore, MD, United States.

Purpose: Over 500,000 cholecystectomies are performed each year in theUS. Gallstones and acute cholecystitis are often the underlying etiology.Common symptoms in patients who undergo cholecystectomy includenausea, vomiting, and abdominal pain. Gastroparesis is a chronic disorderof delayed gastric emptying. Common etiologies include diabetes (DM),prior gastric surgery, connective tissue disorders, or a preceding viralinfection. Symptoms of gastroparesis include nausea, vomiting, and ab-dominal pain. Given the similarity of symptoms in these 2 conditions wesought to determine whether patients with gastroparesis are at increasedrisk to undergo cholecystectomy. Aims: Determine the prevalence of cho-lecystectomy in patients with gastroparesis referred to a tertiary care center;examine whether specific etiologies of gastroparesis increase the likelihood

S51AJG – September, Suppl., 2001 Abstracts