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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05341401

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Chronic	Drug: Budesonide MMX Drug: Prednisolone	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Budesonide MMX this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. Budesonide MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The dose will be 9mg as a single dose given for 8 weeks.	Drug: Budesonide MMX Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
Active Comparator: prednisolone this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. prdinisolone MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The starting dose will be 40 mg and reduced by 5 mg each weak for 8 weeks .	Drug: Prednisolone It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Arm

Intervention/Treatment

Active Comparator: Budesonide MMX

this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. Budesonide MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The dose will be 9mg as a single dose given for 8 weeks.

Drug: Budesonide MMX

Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis

Active Comparator: prednisolone

this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. prdinisolone MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The starting dose will be 40 mg and reduced by 5 mg each weak for 8 weeks .

Drug: Prednisolone

It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Outcome Measures

Primary Outcome Measures

comparison of the efficacy of both budesonide MMX and prednisolone. [8 weeks]
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.
comparison of the efficacy of both budesonide MMX and prednisolone. [8 weeks]
To compare: - laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation
comparison of the efficacy of both budesonide MMX and prednisolone. [8 weeks]
-to compare the : endoscopic out come using mayo scoring system.
comparison of the efficacy of both budesonide MMX and prednisolone. [8 weeks]
to compare the histological remission

Secondary Outcome Measures

incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis [12 months]
to detect the side effects reported by the patients in each group and compare them to each other.
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.