Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Sponsor

Mostafa Bahaa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05988528

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.

Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Mesalamine Drug: Nifuroxazide	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double blinded

Primary Purpose:

Treatment

Official Title:

Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Aug 20, 2027

Anticipated Study Completion Date :

Nov 20, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months	Drug: Mesalamine Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis.
Active Comparator: Nifuroxazide group Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months	Drug: Mesalamine Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis. Drug: Nifuroxazide Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections

Arm

Intervention/Treatment

Active Comparator: control group

Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months

Drug: Mesalamine

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis.

Active Comparator: Nifuroxazide group

Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months

Drug: Mesalamine

Drug: Nifuroxazide

Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections

Outcome Measures

Primary Outcome Measures

The primary endpoint is the improvement in health-related quality of life [6 months]
The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Both male and female will be
Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

Breast feeding
Significant liver and kidney function abnormalities
Colorectal cancer patients
Other inflammatory bowel diseases (CD).
Patients with severe UC
Patients taking rectal or systemic steroids
Patients taking immunosuppressives or biological therapies
Addiction to alcohol and / or drugs
Known allergy to the Fenofibrate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mostafa Bahaa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching assisstant, Tanta University

ClinicalTrials.gov Identifier:

NCT05988528

Other Study ID Numbers:

8/2023

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Nifuroxazide

Mesalamine

Study Results

No Results Posted as of Aug 14, 2023