Safety and Efficacy of Oral Sulfate Tablet in Patients with Inflammatory Bowel Desease

Comparative Study of Oral Sulfate Tablet and PEG for Bowel Preparation in patients with Inflammatory Bowel Disease: prospective randomized singl-blinded trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004685

Enrollment

110

Registered

2020-01-31

Start date

2020-02-28

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Both medicine already come into the market for bowel preparation before colnoscopic examination - Group 1 : OST (Oral Sulfate Tablet :ORA.FANG tablet) i) At 8pm one day before the exam, take

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subjects same or older than 18 years who undergo diagnostic colonoscopy with inflammtory bowel disease ? Subjects who signed to informed consent

Exclusion criteria

Exclusion criteria: ? Subjects with severe obstructive stricture ? Acute severe ulcerative colitis ? Severe constipation (lesser than 3 per week, take laxative) ? History of coloectomy ? Subjects with severe dehydration ? History of liver cirrhosis, ascites , chronic kidney disease, significant other inflammatory disease ? Congestive heart failure, other heart disease(ischemic heart disease within recent 6 months, coronary artery disease) ? Subjects with decreased renal function ( serum creatinine > 3 mg/dl for more than 5 months) ? glucose 6 phosphate dehydrogenase deficiency ? Disabled (cognitive impairment, low inteligence) ? Subjects who refused to sign to informed consent ? Higher than American Society of Anesthesiology class III ? Subjects who do not have blood test results within 3 months (Na / K / Cl, Mg, Calcium, Phosphate, BUN / Creatinine, Estimated glomerular filtaration rate (MDRD CCr)%) ? Pregnant women

Design outcomes

Primary

Measure	Time frame
Harefiel Cleansinf Scale;adenoma and advanced adenoma detection rate;colonoscopy withdrawal time;serum electrolyte and kidney funcion;Bubble level;adverse event during bowel preparation ( safety- nausea, vomiting, abdominal pain, abdominal distension, insomnia, numbness, leghargy, tremor, decreased mentality, fecal incontinence, nephrotoxicity);erythematous mucosal change or aphthous ulcer;flare up of IBD after colonoscopy	—

Measure

Time frame

Harefiel Cleansinf Scale;adenoma and advanced adenoma detection rate;colonoscopy withdrawal time;serum electrolyte and kidney funcion;Bubble level;adverse event during bowel preparation ( safety- nausea, vomiting, abdominal pain, abdominal distension, insomnia, numbness, leghargy, tremor, decreased mentality, fecal incontinence, nephrotoxicity);erythematous mucosal change or aphthous ulcer;flare up of IBD after colonoscopy

—

Secondary

Measure	Time frame
tolerability;adherenc;satisfaction	—

Countries

Korea, Republic of

Contacts

Public ContactHALIN KWON

Yeongnam University Medical Center

Outcome results