Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

Ulcerative Colitis Chronic Clinical Trial

Official title:

Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341401
• Other study ID #: Budesonide in UC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: Ghada M.Kamal Ali, PHD
• Phone: 01008800296
• Email: Ghada.Elefaai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

My study aims to directly compare the efficacy and safety of Budesonide MMX versus Prednisolone in the management of mild to moderate cases of ulcerative colitis.

Description:

It is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide MMX.

The efficacy of Budesonide MMX and Prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. Clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count [CBC], C reactive protein[CRP], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. Endoscopic and histological assessments will be done at week 8.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• This study will include patients with confirmed mild to moderate ulcerative colitis according to the Mayo score activity index with ages ranging between 18-60 years old.

Exclusion Criteria:

• Patients < 18 years old.

• Pregnant females.

• Patients with proven infection with any enteric pathogens (e.g., Shigella species, Clostridium species, Salmonella species, ova, parasites, Clostridium difficile toxins A or B, or HIV infection).

• Patients who received oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks, or anti-tumor necrosis factor agents in the last 3 months.

• Patients with severe colitis (Mayo score >11); Patients with evidence or history of toxic megacolon.

• Severe anemia (hemoglobin <10.5 g/dl), leucopenia, or granulocytopenia.

• Patients using any cytochrome P450 inducers or inhibitors (e.g., ketoconazole, phenytoin) or antibiotics.

• Patients with renal disease/insufficiency.

• Patients with type I diabetes.

• Patients with glaucoma.

• Patients with malignancies.

• Patients with decompensated liver cirrhosis (Child-Pugh score B and C).

• Patients with COVID 19 infection.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis Chronic

Intervention

Drug:
• Budesonide MMX
Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
• Prednisolone
It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of the efficacy of both budesonide MMX and prednisolone.	To compare: - the clinical out come(by number of bowel movement, presence or absence of blood and abdominal pain) assessment will be done at 0 ,4 weeks and after 8 weeks from treatment initiation in both groups.	8 weeks
Primary	comparison of the efficacy of both budesonide MMX and prednisolone.	To compare: - laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation	8 weeks
Primary	comparison of the efficacy of both budesonide MMX and prednisolone.	-to compare the : endoscopic out come using mayo scoring system.	8 weeks
Primary	comparison of the efficacy of both budesonide MMX and prednisolone.	to compare the histological remission	8 weeks
Secondary	incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis	to detect the side effects reported by the patients in each group and compare them to each other.	12 months
Secondary	Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis		12 months