The efficacy of tobramycin in the treatment of ulcerative colitis Double blind, placebo controlled trial of metronidazole in Crohn's disease. Randomized controlled trial of clarithromycin and ethambutol in the treatment of Crohn’s disease Combined budesonide and antibiotic therapy for active Crohn's disease: a randomized controlled trial. Two-year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease. A prospective randomized controlled trial of oral ciprofloxacin in acute ulcerative colitis. Antibiotic therapy for treatment in relapse of intestinal Crohn's disease Intravenous tobramycin and metronidazole as an adjunct to corticosteroids in acute, severe ulcerative colitis. Metronidazole in Crohn's disease. A double blind cross-over clinical trial. Preliminary Study of Ciprofloxacin in Active Crohn's Disease A prospective randomized controlled trial of intravenous ciprofloxacin as an adjunct to corticosteroids in acute, severe ulcerative colitis. Newly Developed Antibiotic Combination Therapy for Ulcerative Colitis: A Double-Blind Placebo-Controlled Multicenter Trial Combination ciprofloxacin and metronidazole for active Crohn's disease. Clinical and endosonographic effect of ciprofloxacin on the treatment of perianal fistulae in Crohn's disease with infliximab: a double‐blind placebo‐controlled study Controlled trial of intravenous metronidazole as an adjunct to corticosteroids in severe ulcerative colitis. A comparative study of metronidazole and sulfasalazine in active, not severe, ulcerative colitis. An Israeli multicenter trial. Effectiveness of antibiotic combination therapy in patients with active ulcerative colitis: A randomized, controlled pilot trial with long-term follow-up Long-term treatment of ulcerative colitis with ciprofloxacin: a prospective, double-blind, placebo-controlled study.
This paper reports a double‐blind placebo‐controlled trial of oral tobramycin in acute ulcerative colitis . Eighty‐four patients with an acute relapse of ulcerative colitis were r and omized to receive oral tobramycin or placebo for 1 week as an adjunct to steroid therapy . At endpoint , 31 of 42 ( 74 % ) in the tobramycin group achieved complete symptomatic remission compared with 18 of 42 ( 43 % ) in the placebo group ( P= 0.008 ) . The tobramycin group achieved better histological scores ( P < 0.05 ) at endpoint . These findings show that treatment with oral tobramycin improves the short‐term outcome of patients with ulcerative colitis in relapse A double blind study compared the efficacy of metronidazole in two doses ( 20 mg/kg , 10 mg/kg ) with placebo in patients with Crohn 's disease . One hundred and five patients participated but only 56 completed the 16 week study -21 were withdrawn for deterioration of symptoms , 17 for adverse experiences , and 11 for protocol violation . Significant improvement in disease activity as measured by the Crohn 's disease activity index  ( metronidazole 20 mg/kg , 97 units ; metronidazole 10 mg/kg , 67 units ; placebo -1 unit , p = 0.002 ) and serum orosomucoid  ( metronidazole 20 mg/kg/day , 49 ; 10 mg/kg/day , 38 ; placebo , -9 , p = 0.001 ) ) were detected . Changes in C reactive protein concentrations did not achieve significance when all three groups were considered but were significant when all metronidazole treated patients were grouped and compared with the placebo treated patients ( 0.8 v -0.9 , p less than 0.05 ) . Although patients receiving metronidazole 20 mg/kg/day had a greater improvement in disease activity than those receiving 10 mg/kg/day ( difference 30 units ( 95 % confidence intervals -27 - 87 ) , the small sample size may have precluded the detection of statistical significance . Preliminary analysis suggests that metronidazole was more effective in patients with disease confined to the large intestine or affecting both small and large bowel than in those with small bowel disease only . There were no differences in remission rates between metronidazole and placebo treated patients . We conclude that metronidazole warrants further assessment in the treatment of patients with active Crohn 's disease A mycobacterial infection may be the cause of Crohn ’s disease in some patients . Measurement of intestinal permeability may identify Crohn ’s disease patients with a high likelihood of relapse and may quantify the severity of intestinal injury BACKGROUND & AIMS Although antibiotics are frequently used to treat Crohn 's disease , this practice is not supported by strong evidence from r and omized trials . METHODS We conducted a double-blind multicenter study of patients with active Crohn 's disease of the ileum , right colon , or both . Patients were r and omized to receive oral ciprofloxacin and metronidazole , both 500 mg twice daily , or placebo for 8 weeks . All patients received oral budesonide 9 mg once daily . The primary efficacy measure was the proportion of patients in remission at week 8 . RESULTS Of the 134 patients who were r and omized , 130 were evaluated for efficacy ; 66 received placebo , and 64 received antibiotics . At week 8 , 21 patients ( 33 % ) assigned to antibiotics were in remission as compared with 25 patients ( 38 % ) in the placebo group ( P = 0.55 ; absolute difference , -5 % ; 95 % confidence interval , -21 % to 11 % ) . An interaction ( P = 0.025 ) between treatment allocation and disease location on treatment response was identified . Among patients with disease of the colon , 9 of 17 ( 53 % ) were in remission after treatment with antibiotics , compared with 4 of 16 ( 25 % ) of those who received placebo ( P = 0.10 ) . Discontinuation of therapy because of adverse events occurred in 13 of 66 ( 20 % ) patients treated with antibiotics , compared with 0 of 68 in the group who received placebo ( P < 0.001 ) . CONCLUSIONS In patients with active Crohn 's disease of the ileum , the addition of ciprofloxacin and metronidazole to budesonide is an ineffective intervention , but this antibiotic combination may improve outcome when there is involvement of the colon BACKGROUND & AIMS Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn 's disease . We report a prospect i ve , parallel , placebo-controlled , double-blind , r and omized trial of 2 years of clarithromycin , rifabutin , and clofazimine in active Crohn 's disease , with a further year of follow-up . METHODS Two hundred thirteen patients were r and omized to clarithromycin 750 mg/day , rifabutin 450 mg/day , clofazimine 50 mg/day or placebo  , in addition to a 16-week tapering course of prednisolone . Those in remission ( Crohn 's Disease Activity Index < or=150 ) at week 16 continued their study medications in the maintenance phase of the trial . Primary end points were the proportion of patients experiencing at least 1 relapse at 12 , 24 , and 36 months . RESULTS At week 16 , there were significantly more subjects in remission in the antibiotic arm ( 66 % ) than the placebo arm ( 50 % ; P=.02 ) . Of 122 subjects entering the maintenance phase , 39 % taking antibiotics experienced at least 1 relapse between weeks 16 and 52 , compared with 56 % taking placebo ( P=.054 ) . At week 104 , the figures were 26 % and 43 % , respectively ( P=.14 ) . During the following year , 59 % of the antibiotic group and 50 % of the placebo group relapsed ( P=.54 ) . CONCLUSIONS Using combination antibiotic therapy with clarithromycin , rifabutin , and clofazimine for up to 2 years , we did not find evidence of a sustained benefit . This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn 's disease in the majority of patients . Short-term improvement was seen when this combination was added to corticosteroids , most likely because of nonspecific antibacterial effects OBJECTIVES The aim of this prospect i ve , r and omized , controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis . METHODS Seventy consecutive patients with mild ( n = 37 ) or moderately active ( n = 33 ) ulcerative colitis were r and omized to receive oral ciprofloxacin ( 250 mg b.i.d . , n = 34 ) or placebo ( n = 36 ) for 14 days . In addition , they were given oral prednisolone ( initial dose 20 or 40 mg for mild and moderately active ulcerative colitis , respectively ) and rectal betamethasone enemas ( 2 g at night ) for 7 - 9 weeks . All patients were receiving olsalazine ( 0.5 g twice daily ) . At study entry , the groups were similar with respect to age , sex , extent , duration , and severity of disease , and previous treatments . Patients were assessed clinical ly , endoscopically , and histologically before , at the end of the trial ( day 14 ) , and on completion of steroid treatment , or at any time worsening of symptoms or a complication of ulcerative colitis occurred . RESULTS At the end of the study , 24 patients ( 70.5 % ) in the ciprofloxacin group and 26 patients ( 72 % ) in the placebo group achieved remission ( p > 0.1 , Yates chi 2 ) . Ten patients in each group necessitated higher doses of oral ( n = 12 ) or intravenous ( n = 8) steroids . Of the latter patients , two underwent emergency colectomy without perioperative deaths . Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment . CONCLUSIONS A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission We have undertaken a prospect i ve r and omized trial of one month 's antimicrobial therapy for patients with symptomatic relapse of Crohn 's disease . Criteria for entry included two major symptoms : fever , abdominal pain , diarrhea , weight loss , abdominal mass or complications ( excluding perianal disease ) ; and two hematologic abnormalities : hemoglobin , ESR , albumin , C reactive protein , iron , or total iron binding capacity . Patients were monitored for the aforementioned clinical and hematologic ( hemoglobin , albumin , CRP ) parameters over six weeks and for changes in fecal flora . R and omization was to four groups : metronidazole alone ( M ) , cotrimoxazole alone ( C ) , metronidazole and cotrimoxazole ( C plus M ) , or double placebo ( P ) . Seventy-two patients entered the study ( 18=M , 16=C 21=C plus M , 17=P ) . After two weeks , improvement was reported as follows : M=67 percent , C=17 percent , C plus M=71 percent , P=35 percent . In the metronidazole group , two patients required surgery and one had trouble-some side effects . In the cotrimoxazole group , two had side effects . In the combined group ( C plus M ) , four had troublesome side effects and two of the placebo group ( P ) required operation . By four weeks , there was no difference in response among the groups : ( M=44 percent , C=62 percent , C plus M=57 percent , P=41 percent ) . Antimicrobials had no effect on fecal flora or hematologic parameters . These results indicate that antimicrobials have little therapeutic potential for relapse of intestinal Crohn 's disease OBJECTIVES The aim of this study was to evaluate the role of metronidazole and tobramycin as an adjunct to corticosteroids in acute , severe ulcerative colitis . METHODS Thirty-nine consecutive patients with severe ulcerative colitis were r and omized on admission to the hospital to receive intravenously either metronidazole ( 0.5 g tid ) and tobramycin ( 4 mg/kg tid ) ( n = 19 ) , or placebo ( n = 20 ) . In addition , they were given parenteral nutrition , intravenous hydrocortisone ( 100 mg qid ) and hydrocortisone enemas ( 100 mg bid ) . All patients were assessed after 10 days of continuous treatment , or at any time a severe complication occurred . RESULTS Twelve of 19 patients ( 63.15 % ) treated with antibiotics and 13/20 patients ( 65 % ) with placebo showed substantial improvement . Seven patients in each group did not improve ( n = 9 ) , or developed complications ( n = 5 ) and underwent emergency colectomy without perioperative deaths or late deaths . CONCLUSIONS These results do not support the routine use of intravenous tobramycin and metronidazole in the treatment of severe ulcerative colitis Twenty-two patients with active Crohn 's disease treated with salazosulfapyridin or prednisone  , were in addition given metronidazole 1.000 mg daily or placebo for two months each in a double-blind cross-over study . No statistically significant effect was observed on the overall clinical condition in the 20 patients who completed the trial , although haemoglobin rose and ESR fell significantly in the metronidazole periods . In the 6 patients with colonic involvement only an improvement was registered both in symptoms and laboratory values Based on limited reports of the successful use of antibiotics in the treatment of Crohn 's disease ( CD ) and on the possibility that intestinal bacteria may be one of the etiologic factors playing a role in the pathogenesis of this condition , we undertook a study to evaluate the use of a broad-spectrum antibiotic in CD . Our team studied the efficacy of adding the antibiotic ciprofloxacin to the treatment of moderately active , but resistant cases of CD . Forty-seven adults with moderately active CD were r and omly assigned treatment with ciprofloxacin 500 mg twice daily versus placebo twice daily for 6 months . The primary endpoint was the change in scores on the Crohn 's Disease Activity Index ( CDAI ) from baseline to month 6 . Although 47 patients were r and omized , at 1 month of follow-up 28 patients received ciprofloxacin and 19 received placebo . The mean entry CDAI scores were not significantly different : 187 for the ciprofloxacin group versus 230 for the placebo group ( p = 0.638 ) . Mean CDAI scores at the completion of study were 112 for the ciprofloxacin group ( n = 25 ) and 205 for the placebo group ( n = 12 ) , ( p < 0.001 ) . Disease remission is defined as a decrease in the CDAI score to less than 150 points . Our preliminary study suggests that ciprofloxacin may be an effective agent when added to the treatment of moderately active , resistant CD BACKGROUND The role of antibiotics in the treatment of ulcerative colitis is controversial . This study aims at assessing the therapeutic role of ciprofloxacin as an adjunct to corticosteroids in acute severe ulcerative colitis . METHODS In this prospect i ve , r and omized , double-blind , placebo-controlled trial , 55 consecutive patients fulfilling the criteria of Truelove and Witts for severe ulcerative colitis were r and omized on admission to the hospital to receive intravenously ciprofloxacin  ( 400 mg b.i.d . ) ( n = 29 ) or placebo ( n = 27 ) . All patients received parenteral nutrition , intravenous hydrocortisone ( 100 mg q.i.d . ) and hydrocortisone enemas ( 100 mg b.i.d . ) . Patients were assessed after 10 days of continuous treatment , or at any time a severe complication occurred . RESULTS At study entry , there were no significant differences between treatment groups in any patient or disease-related parameter . Twenty-three of 29 patients ( 79.3 % ) treated with ciprofloxacin and 20 of 26 patients ( 77 % ) treated with placebo showed substantial improvement and were given oral steroids ( P > 0.1 ) . Six patients in each group did not improve ( n = 10 ) or developed complications ( n = 2 ) . Nine of these 12 patients underwent emergency colectomy ; three patients consented to receive intravenous cyclosporin but did not achieve remission of colitis and they underwent elective colectomy . There were no perioperative or late deaths . CONCLUSIONS A short course of intravenous ciprofloxacin does not seem to augment the effect of corticosteroids for patients with acute , severe ulcerative colitis OBJECTIVES : Fusobacterium varium may contribute to ulcerative colitis ( UC ) . We conducted a double-blind placebo-controlled multicenter trial to determine whether antibiotic combination therapy induces and /or maintains remission of active UC . METHODS : Patients with chronic mild-to-severe relapsing UC were r and omly assigned to oral amoxicillin 1500 mg/day , tetracycline 1500 mg/day , and metronidazole 750 mg/day , vs. placebo , for 2 weeks , and then followed up . The primary study end point was clinical response ( Mayo score at 3 months after treatment completion ) and secondary end points were clinical and endoscopic score improvements at 12 months . Anti-F. varium antibodies were measured by enzyme-linked immunosorbent assay . RESULTS : Treatment and placebo groups each had 105 subjects . At the primary end point , response rates were significantly greater with antibiotics than with placebo ( 44.8 vs. 22.8 % , P=0.0011 ) . Endoscopic scores significantly improved at 3 months ( P=0.002 vs. placebo ) . Remission rates were 19.0 % ( antibiotics ) vs. 15.8 % ( placebo ) at 3 months ( P=0.59 ) . At the secondary end point , response rates were significantly greater with antibiotics than with placebo ( 49.5 vs. 21.8 % , respectively , P<0.0001 ) . Endoscopic scores were significantly improved at 12 months after antibiotic treatment ( P=0.002 vs. placebo ) . Remission rates had improved to 26.7 % with antibiotics vs. 14.9 % for placebo , at 12 months ( P=0.041 ) . F. varium antibody titers decreased in responders but not in nonresponders , and more in the antibiotic than in the placebo group . More pretreatment steroid-dependent UC patients discontinued corticosteroids after treatment completion ( 6 months : 28.6 vs. 11.8 % , respectively , P=0.046 ; 9 months : 34.7 vs. 13.7 % , respectively , P=0.019 ; and 12 months : 34.7 vs. 13.7 % , respectively , P=0.019 ) . These effects were greater in the sub analysis of the active group ( Mayo scores of 6–12 ) than in that of total cases ( 0–12 ) . No serious drug-related toxicities occurred . CONCLUSIONS : The 2-week triple antibiotic therapy produced improvement , remission , and steroid withdrawal in active UC more effectively than a placebo Recent experimental evidence underscores the contribution of intestinal bacteria to the inflammatory process of Crohn 's disease . This open study examined the efficacy and safety of combination ciprofloxacin and metronidazole for patients with active Crohn 's disease of the ileum and /or colon . Seventy-two patients with active Crohn 's disease of the ileum ( n = 27 ) , ileocolon ( n = 22 ) or colon ( n = 23 ) were treated with ciprofloxacin 500 mg bid and metronidazole 250 mg tid for a mean of 10 weeks . Clinical remission was defined as a Harvey-Bradshaw index of three points or less ; an index reduction of at least three points indicated a clinical response . Clinical remission was observed in 49 patients ( 68 % ) , and 55 patients ( 76 % ) showed a clinical response . A clinical response was noted in 29 of 43 patients ( 67 % ) who were not taking concurrent prednisone treatment and in 26 of 29 patients ( 90 % ) receiving prednisone ( mean dose of 15 mg/day ) . A clinical response also occurred in a greater proportion of patients with colonic disease , with or without ileal involvement ( 84 % ) , compared with patients with ileal disease alone ( 64 % ) , and in patients without resection ( 86 % ) compared with those with previous resection ( 61 % ) . Five patients discontinued antibiotics because of adverse events . After a mean follow-up of nine months , clinical remission was maintained in 26 patients off treatment and in 12 patients who continued antibiotic therapy . Ciprofloxacin in combination with metronidazole is well tolerated and appears to play a beneficial role in achieving clinical remission for patients with active Crohn 's disease , particularly when there is involvement of the colon Background : Ciprofloxacin is effective in perianal Crohn 's disease but after treatment discontinuation symptoms reoccur . Infliximab is effective but requires maintenance therapy A prospect i ve double blind controlled trial was undertaken to examine the role of metronidazole as an adjunct to corticosteroids in the management of  severe ulcerative colitis . Thirty nine patients with severe ulcerative colitis were r and omised on admission to hospital to receive either intravenous metronidazole 500 mg eight hourly ( 19 patients ) or an identical intravenous placebo ( 20 patients ) . The two groups were similar with respect to age , sex , and the extent of colitis . In addition all patients received a st and ard intravenous regimen consisting of methyl prednisolone 16 mg six hourly and parenteral nutrition together with a twice daily hydrocortisone 100 mg enema . Treatment was continued for five days when the patients were formally assessed . Fourteen of 19 patients ( 74 % ) receiving metronidazole and 14/20 ( 70 % ) receiving placebo were substantially improved , or in remission at the end of five days . Five patients treated with metronidazole and six with placebo had no improvement and all proceeded to urgent colectomy with no operative mortality . There were three late deaths , one in the metronidazole and two in the placebo group . These results do not support the routine use of intravenous  metronidazole  in the treatment of severe ulcerative colitis Since metronidazole ( M ) was found to be effective in Crohn 's disease , we evaluated its efficacy in the treatment of active ulcerative colitis ( UC ) . Forty-six out patients with acute , nonsevere UC were studied . Forty-two concluded the trial . Twenty-three received M 1.35 g/day and 19 received sulfasalazine ( S ) 4.5 g/day for 28 days in a r and omized double-blind study . Six of 23 receiving M improved ( 26 % ) as against 13 of 19 patients receiving S ( 68 % ) ( p less than 0.01 ) . No significant side effects were noted . We conclude that M is ineffective in the therapy of an acute attack of UC Objective . It is proposed that Fusobacterium varium might be one of the elusive pathogenic factors in ulcerative colitis ( UC ) . Our goal was to assess whether an antibiotic combination therapy against F. varium is effective for induction and maintenance of remission of UC . Material and methods . Twenty chronic , active UC patients with F. varium infection were enrolled consecutively and were r and omly assigned to receive amoxicillin , tetracycline or metronidazole per os for 2 weeks ( treatment group ; n=10 ) , or no antibiotics ( control group ; n=10 ) . F. varium was sensitive to the antibiotics . Symptom assessment , endoscopic and histological evaluations were performed blind before enrollment at 3–5 months and 12–14 months after the treatment . Serum immunoglobulins to F. varium were measured using an enzyme-linked immunosorbent assay ( ELISA ) . Immunohistochemical detection of F. varium in biopsy specimens was carried out using the avidin-biotin complex method . Results . The clinical activity , endoscopic and histological scores in the treatment group decreased significantly at 3–5 and 12–14 months after the end of treatment compared with those in the control group ( p=0.001–0.036 ) . The remission rate in the treatment group was higher than that in the control group ( p=0.037 ) . In addition , the titers of antibody to F. varium and the F. varium density in the mucosa decreased at both the short- and long-term follow-ups in the treatment group ( p=0.0002–0.049 ) . No serious drug-related toxicity was observed during the trial . Conclusions . The 2-week antibiotic combination therapy against F. varium was effective and safe in patients with chronic , active ulcerative colitis in this long-term follow-up study BACKGROUND & AIMS Although bacterial bowel flora may be one of the contributing factors in the pathogenesis of chronic mucosal inflammation , antibiotic treatment has no established role in ulcerative colitis . The aim of the study was to evaluate the role of ciprofloxacin in the induction and maintenance of remission in ulcerative colitis in patients responding poorly to conventional therapy with steroids and mesalamine . METHODS  Ciprofloxacin ( n = 38 ; 500 - 750 mg twice a day ) or placebo ( n = 45 ) was administered for 6 months in a double-blind , r and omized study with a high but decreasing dose of prednisone and maintenance treatment with mesalamine including follow-up for the next 6 months . Clinical assessment and colonoscopic evaluation were performed at 0 , 3 , 6 , and 12 months . Treatment failure , the primary end point , was defined as both symptomatic and endoscopic failure to respond . RESULTS During the first 6 months , the treatment-failure rate was 21 % in the ciprofloxacin-treated group and 44 % in the placebo group ( P = 0.02 ) . Endoscopic and histological findings were used as secondary end points and showed better results in the ciprofloxacin group at 3 months but not at 6 months . CONCLUSIONS Addition of a 6-month ciprofloxacin treatment for ulcerative colitis improved the results of conventional therapy with mesalamine and prednisone
Patients with Crohn 's disease ( CD ) or ulcerative colitis ( UC ) undergo various therapies , including antibiotic therapy .
This meta- analysis of controlled clinical trials was conducted to evaluate whether the use of antibacterial therapy improves the clinical symptoms of inflammatory bowel disease ( IBD ) .