Large scale clinical evaluation of bowel contrast agent containing ferric ammonium citrate in MRI.

Clear identification of bowel has been thought to be essential in diagnosis by abdominal MRI. We have completed the clinical phase III trial of a new oral contrast agent (FerriSeltz) which is a ferric ammonium citrate based bowel contrast agent. FerriSeltz is a powder that is dissolved in 300 ml water to create a grape-flavored effervescent drink. We have evaluated the usefulness of FerriSeltz, and compared groups receiving 600 mg and 1200 mg of ferric ammonium citrate, the use and nonuse of parasympathetic blockers, and patients with and without fasting in 174 patients who underwent abdominal MRI using this agent. FerriSeltz was found to brighten the stomach and duodenum, contribute to the improvement in diagnostic efficacy, be safe as a bowel contrast agent in abdominal MRI, and be associated with an extremely low incidence of side effects (only mild diarrhea in one of 169 patients). No significant differences were found in the contribution to the improvement in diagnostic efficacy between the two dosage groups, the use and nonuse of parasympathetic blockers, or patients with and without fasting. We concluded that ferric ammonium citrate based compound (FerriSeltz) is a promising bowel contrast agent in abdominal MRI.

RCT Entities:   Population Interventions Outcomes