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Effect of a probiotic, VSL#3, in diarrhea-predominant irritable bowel syndrome: a randomized, double blind, placebo controlled trial
AJG – September, Suppl., 2002
ing infliximab. 2 had serum sickness with infliximab retreatment. 1 patient died after colon perforation due to colonoscopy. Conclusions: 2% of our CD patients have symptomatic GCD. IMRx is useful to treat this rare condition and can be more aggressively pursued since the advent of 6TG metabolite testing and use of infliximab for maintenance in CD. Endoscopic dilation is a useful adjunct and can rapidly improve symptoms. Surgery should be reserved for those failing medical and endoscopic therapy but can yield satisfactory results as well.
FUNCTIONAL BOWEL DISORDERS 830 EFFECT OF A PROBIOTIC, VSL#3, IN DIARRHEA–PREDOMINANT IRRITABLE BOWEL SYNDROME: A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL H. Jae Kim, M.D., Michael Camilleri, M.D., FACG*, Sanna McKinzie, M.S., Duane Burton, George Thomforde and Alan R. Zinsmeister, Ph.D. Clinical Enteric Neuroscience Translational & Epidemiological Research (C.E.N.T.E.R) Program, Mayo Clinic, Rochester, MN. Purpose: Recent clinical studies have demonstrated that the probiotics are efficacious in treating various diarrheal illnesses. The influence of probiotic on gastrointestinal transit in patients with irritable bowel syndrome (IBS) is unclear. We investigated the effect of VSL#3 on the gastrointestinal transit and symptoms of patients with diarrhea–predominant IBS. Methods: Patients fulfilling the Rome II criteria with diarrhea–predominant symptoms and without a history of organic gastrointestinal disease were recruited. Twenty–five patients were randomly assigned to VSL#3 powder or matching placebo twice daily for 8 weeks after a 2 week baseline period to assess symptoms. The VSL#3 group received 450 billion lyophilized bacteria per day. Pre– and post–treatment gastrointestinal transit measurements were performed in all patients. Patients recorded their bowel function and symptoms daily for the entire study. The primary endpoint of the study was colonic geometric center at 24 hours, and secondary endpoints were; gastric emptying at 2 and 4 hours, colonic filling at 6 hours, colonic geometric center at 48 hours, proportion of responders, and individual symptoms and bowel functions. Results: There were no significant differences of the mean gastrointestinal transit measurements between the two groups, pre– and post–therapy. Overall, individual IBS symptoms and satisfactory relief of IBS were not different between VSL#3 and placebo group; however, abdominal bloating was significantly reduced in the VSL#3 group (post vs pre, P ⫽ 0.04) and not in the placebo group (post vs pre, P ⫽ 0.78). The scores for flatulence, abdominal pain, and urgency were not significantly reduced in patients treated with VSL#3. All patients tolerated the VSL#3 well. One patient, who was later shown to be randomized to placebo, withdrew from the study due to a severe abdominal pain. Conclusions: VSL#3 appears promising in the relief of abdominal bloating in patients with diarrhea–predominant IBS. This effect is unrelated to alteration in gastrointestinal or colon transit. 831 SELF–EFFICACY IN DRINK TESTING (DT) Michael P. Jones, M.D.* and Christine C. Ebert, M.A. Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL. Purpose: Self– efficacy is the ability to accurately predict performance. Healthy individuals have a good sense of the volume of food or drink needed to produce satiety but this is not well studied. Similarly, self– efficacy has not been evaluated in patients with functional or neuromuscular disorders of the UGI tract. The aim of this study was to determine the ability of healthy controls (Ctrls), gastroparetics (GP) and functional dyspeptics (FD) to predict the volume of water required to produce fullness.
Abstracts
S273
Methods: Ctrls, GP and FD were recruited consecutively. GP was defined as repeated episodes of nausea and vomiting and delayed gastric emptying. FD was defined by Rome II criteria. Subjects estimated their ability to drink using a 100mm VAS (0⫽ “very little”;100mm⫽“a very large amount”). DT required subjects to consume room temperature water from an unlabelled, bottomless flask ad libitum over a 5min period until full. Data were expressed as mean⫾SE. VAS scores and DT volumes were correlated and regression equations determined. Results: 22 ctrls, 23 FD and 16 GP were studied. DT volumes were significantly less for FD (404⫾45ml; p⫽0.0003) and GP (298⫾51ml; p⬍0.0001) compared with ctrls (657⫾45ml) but did not differ from each other. Similarly, VAS scores for FD (45⫾4mm; p⫽0.03) and GP (44⫾6mm; p⫽0.0569) were lower than ctrls (58⫾4mm) but also not different from each other. VAS and DT were significantly correlated for ctrls (r⫽0.58; p⫽0.0051) and GP (r⫽0.55; p⫽0.0259) but not for FD (r⫽0.16; p⫽0.47) (see figure).
Conclusions: For ctrls, estimated drinking ability and DT are highly correlated. Similarly, GP maintain good sense of drinking capacity despite impaired gastric function. In FD, however, the ability to accurately estimate drinking capacity is absent. These data further support deranged afferent function in FD. 832 DURABILITY OF THE IRRITABLE BOWEL SYNDROME DIAGNOSIS Olaitan A. Adeniji, M.D., Cody B. Barnett, M.D. and Jack A. Di Palma, M.D.*. Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, AL. Purpose: To evaluate the durability of the diagnosis of Irritable Bowel Syndrome (IBS) based on clinical criteria. Prior studies evaluating the prognosis of patients diagnosed with IBS have had small numbers of patients or a short duration of observation. Methods: The study population consisted of a cohort of patients evaluated for IBS between 1989 and 1992, who met the International Congress of Gastroenterology Rome I criteria for IBS at the time of initial diagnosis. Patients were re–interviewed for cardinal features of IBS, Rome I, Rome II and Manning criteria 10 –13 years after the initial diagnosis. Results: There were 75 patients; 14 males and 61 females with mean age of 47.5 years ⫾ 11.3 S.D., range 20 to 75 years. Mean time of re–interview after initial diagnosis was 11.8 years ⫾ 0.9 S.D., range 10 to 13 years. None of the 75 patients had the diagnosis of IBS refuted during the observation period. Other gastrointestinal diagnoses noted during this observational period included diverticulitis (5), uterine fibromyoma (3) and gallbladder disease (3). Sixty–nine patients (92%) did not consider their symptoms as resolved. Thirty–five (46.67%) had repeat structural evaluation of the colon for similar symptoms without any change in diagnosis. Twenty–six (34.7%) and 32 (42.7%) presently meet the Rome II and Rome I criteria for IBS, respectively. Conclusions: The prognosis of Irritable Bowel Syndrome is good. These data support the use of clinical criteria for a specific and durable diagnosis of IBS. 833 FRUCTOSE INTOLERANCE AND IRRITABLE BOWEL SYNDROME (IBS) Young K. Choi, M.D., Michelle Jackson, Robert Summers, M.D. and Satish Rao, M.D.*. Internal Medicine/ Division of Gastroenterology, University of Iowa, Iowa City, IA.
ing infliximab. 2 had serum sickness with infliximab retreatment. 1 patient died after colon perforation due to colonoscopy. Conclusions: 2% of our CD patients have symptomatic GCD. IMRx is useful to treat this rare condition and can be more aggressively pursued since the advent of 6TG metabolite testing and use of infliximab for maintenance in CD. Endoscopic dilation is a useful adjunct and can rapidly improve symptoms. Surgery should be reserved for those failing medical and endoscopic therapy but can yield satisfactory results as well.
FUNCTIONAL BOWEL DISORDERS 830 EFFECT OF A PROBIOTIC, VSL#3, IN DIARRHEA–PREDOMINANT IRRITABLE BOWEL SYNDROME: A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL H. Jae Kim, M.D., Michael Camilleri, M.D., FACG*, Sanna McKinzie, M.S., Duane Burton, George Thomforde and Alan R. Zinsmeister, Ph.D. Clinical Enteric Neuroscience Translational & Epidemiological Research (C.E.N.T.E.R) Program, Mayo Clinic, Rochester, MN. Purpose: Recent clinical studies have demonstrated that the probiotics are efficacious in treating various diarrheal illnesses. The influence of probiotic on gastrointestinal transit in patients with irritable bowel syndrome (IBS) is unclear. We investigated the effect of VSL#3 on the gastrointestinal transit and symptoms of patients with diarrhea–predominant IBS. Methods: Patients fulfilling the Rome II criteria with diarrhea–predominant symptoms and without a history of organic gastrointestinal disease were recruited. Twenty–five patients were randomly assigned to VSL#3 powder or matching placebo twice daily for 8 weeks after a 2 week baseline period to assess symptoms. The VSL#3 group received 450 billion lyophilized bacteria per day. Pre– and post–treatment gastrointestinal transit measurements were performed in all patients. Patients recorded their bowel function and symptoms daily for the entire study. The primary endpoint of the study was colonic geometric center at 24 hours, and secondary endpoints were; gastric emptying at 2 and 4 hours, colonic filling at 6 hours, colonic geometric center at 48 hours, proportion of responders, and individual symptoms and bowel functions. Results: There were no significant differences of the mean gastrointestinal transit measurements between the two groups, pre– and post–therapy. Overall, individual IBS symptoms and satisfactory relief of IBS were not different between VSL#3 and placebo group; however, abdominal bloating was significantly reduced in the VSL#3 group (post vs pre, P ⫽ 0.04) and not in the placebo group (post vs pre, P ⫽ 0.78). The scores for flatulence, abdominal pain, and urgency were not significantly reduced in patients treated with VSL#3. All patients tolerated the VSL#3 well. One patient, who was later shown to be randomized to placebo, withdrew from the study due to a severe abdominal pain. Conclusions: VSL#3 appears promising in the relief of abdominal bloating in patients with diarrhea–predominant IBS. This effect is unrelated to alteration in gastrointestinal or colon transit. 831 SELF–EFFICACY IN DRINK TESTING (DT) Michael P. Jones, M.D.* and Christine C. Ebert, M.A. Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, IL. Purpose: Self– efficacy is the ability to accurately predict performance. Healthy individuals have a good sense of the volume of food or drink needed to produce satiety but this is not well studied. Similarly, self– efficacy has not been evaluated in patients with functional or neuromuscular disorders of the UGI tract. The aim of this study was to determine the ability of healthy controls (Ctrls), gastroparetics (GP) and functional dyspeptics (FD) to predict the volume of water required to produce fullness.
Abstracts
S273
Methods: Ctrls, GP and FD were recruited consecutively. GP was defined as repeated episodes of nausea and vomiting and delayed gastric emptying. FD was defined by Rome II criteria. Subjects estimated their ability to drink using a 100mm VAS (0⫽ “very little”;100mm⫽“a very large amount”). DT required subjects to consume room temperature water from an unlabelled, bottomless flask ad libitum over a 5min period until full. Data were expressed as mean⫾SE. VAS scores and DT volumes were correlated and regression equations determined. Results: 22 ctrls, 23 FD and 16 GP were studied. DT volumes were significantly less for FD (404⫾45ml; p⫽0.0003) and GP (298⫾51ml; p⬍0.0001) compared with ctrls (657⫾45ml) but did not differ from each other. Similarly, VAS scores for FD (45⫾4mm; p⫽0.03) and GP (44⫾6mm; p⫽0.0569) were lower than ctrls (58⫾4mm) but also not different from each other. VAS and DT were significantly correlated for ctrls (r⫽0.58; p⫽0.0051) and GP (r⫽0.55; p⫽0.0259) but not for FD (r⫽0.16; p⫽0.47) (see figure).
Conclusions: For ctrls, estimated drinking ability and DT are highly correlated. Similarly, GP maintain good sense of drinking capacity despite impaired gastric function. In FD, however, the ability to accurately estimate drinking capacity is absent. These data further support deranged afferent function in FD. 832 DURABILITY OF THE IRRITABLE BOWEL SYNDROME DIAGNOSIS Olaitan A. Adeniji, M.D., Cody B. Barnett, M.D. and Jack A. Di Palma, M.D.*. Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, AL. Purpose: To evaluate the durability of the diagnosis of Irritable Bowel Syndrome (IBS) based on clinical criteria. Prior studies evaluating the prognosis of patients diagnosed with IBS have had small numbers of patients or a short duration of observation. Methods: The study population consisted of a cohort of patients evaluated for IBS between 1989 and 1992, who met the International Congress of Gastroenterology Rome I criteria for IBS at the time of initial diagnosis. Patients were re–interviewed for cardinal features of IBS, Rome I, Rome II and Manning criteria 10 –13 years after the initial diagnosis. Results: There were 75 patients; 14 males and 61 females with mean age of 47.5 years ⫾ 11.3 S.D., range 20 to 75 years. Mean time of re–interview after initial diagnosis was 11.8 years ⫾ 0.9 S.D., range 10 to 13 years. None of the 75 patients had the diagnosis of IBS refuted during the observation period. Other gastrointestinal diagnoses noted during this observational period included diverticulitis (5), uterine fibromyoma (3) and gallbladder disease (3). Sixty–nine patients (92%) did not consider their symptoms as resolved. Thirty–five (46.67%) had repeat structural evaluation of the colon for similar symptoms without any change in diagnosis. Twenty–six (34.7%) and 32 (42.7%) presently meet the Rome II and Rome I criteria for IBS, respectively. Conclusions: The prognosis of Irritable Bowel Syndrome is good. These data support the use of clinical criteria for a specific and durable diagnosis of IBS. 833 FRUCTOSE INTOLERANCE AND IRRITABLE BOWEL SYNDROME (IBS) Young K. Choi, M.D., Michelle Jackson, Robert Summers, M.D. and Satish Rao, M.D.*. Internal Medicine/ Division of Gastroenterology, University of Iowa, Iowa City, IA.