Comparison of the effects of omeprazole in prevention of gastrointestinal events in patients with multiple sclerosis receiving corticosteroid pulse therapy

Phase 3

Recruiting

Conditions: Condition 1: Multiple Sclerosis. Condition 2: Gastrointestinal problems.
Multiple sclerosis
Disease of digestive system, unspecified
K92.9

Registration Number: IRCT20201210049674N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 102

Inclusion Criteria

Patients with recurrent types of MS between 18 and 65 years and hospitalized
Receive 1 gram of corticosteroid pulse daily for at least 3 days
Patient consent to participate in the study

Exclusion Criteria

Presence or history of peptic ulcer disease or gastroesophageal reflux disease or inflammatory bowel disease such as colitis and Crohn's disease
Simultaneous administration of other drugs that cause damage to the gastrointestinal mucosa and increase the risk of ulcers and bleeding, such as oral corticosteroids, NSAIDs, anticoagulants, antiplatelets, etc
Receive acid-suppressing drugs such as PPIs and H2R antagonists in the last week
Acute or chronic renal and hepatic failure clcr<30 , child-pughscore<2
Pregnancy and lactation
Patients receiving IVIG or plasma exchange at the same time, other than a corticosteroid pulse.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dyspepsia symptoms (including abdominal pain, nausea, heartburn, vomiting). Timepoint: Baseline, at the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct questioning of the patient and, if necessary, clinical examination.;The dose of Famotidine as PRN for dyspepsia management. Timepoint: At the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct observing the patient medical report regarding the dose of drug receiving.;Defecation changes. Timepoint: Baseline, at the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct questioning of the patient and, if necessary, clinical examination.

Secondary Outcome Measures