Trial of Mesalamine for the Treatment of Active Microscopic Colitis

Status Completed

Clinical Trial Summary

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.

Clinical Trial Description

We propose a prospective, randomized trial of mesalamine at 1.2g and 4.8g doses for the treatment of microscopic colitis. Our hypothesis is mesalamine is safe and effective for the treatment of diarrhea in microscopic colitis and that the 4.8g dose is more effective than the 1.2g dose.

We will recruit 70 subjects. The subjects will be randomized into to two groups, 4.8g dose, and 1.2g dose groups. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Responders will be followed for 4 weeks post medication.

Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Subjects will be excluded if they have unsuccessful treatment or side effects to 5-ASA drugs, oral corticosteroids, or salicylate. and antibiotics, mesalamine, bismuth or steroid use in the last two weeks. Subjects may not be on anticholinergics, cholestyramine, digoxin. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions.

A two-sample z-score test for proportions will be used to test whether relief rates are different between groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00952952
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	February 2007
Completion date	November 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06283784` - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients	N/A
Recruiting	`NCT03851835` - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis	Phase 3
Completed	`NCT04003181` - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon	N/A
Completed	`NCT03596827` - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection	N/A
Recruiting	`NCT05372068` - Cement flooRs AnD chiLd hEalth (CRADLE)	N/A
Completed	`NCT03972618` - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT05052489` - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed	`NCT02428647` - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation	N/A
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT01739231` - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults	Phase 1/Phase 2
Completed	`NCT01968408` - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children	Phase 3
Not yet recruiting	`NCT01382199` - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients	Phase 3
Completed	`NCT01438645` - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy	N/A
Terminated	`NCT01472211` - Water-based Zinc Intervention Trial in Zinc Deficient Children	Phase 0
Terminated	`NCT01048567` - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly	Phase 2
Completed	`NCT01371656` - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Phase 3
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT00760851` - Yogurt Study in Children 2-4 Years Old Attending Daycare	Phase 3