Saffron as Anti Inflammatory In Patients With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title: Efficacy of Nutritional Saffron Supplement as an Anti-inflammatory Agent in Egyptian Patients With Inflammatory Bowel Disease

Status Not yet recruiting

Clinical Trial Summary

Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. The investigators use saffron extract in Egyptian patients with ulcerative colitis for 8 weeks.

Clinical Trial Description

The patients invited to participate in a research study on Inflammatory Bowel Diseases (IBD) and saffron as a nutritional anti-inflammatory supplement.

Inflammatory Bowel Disease (IBD) is composed of Crohn's Disease (CD) and Ulcerative Colitis (UC). Continuous altered immune responses and inflammation associate with this disease. More than two-thirds of patients reported that IBD-associated symptoms negatively affected their quality of life and their performance at work.

• Patients with IBD are generally put on immunosuppressants (that block or slow participants' immune system to lower the level of inflammation). Long-term use of these immunosuppressants have some serious side effects.

• The goal of this protocol is to lower the need for these immunosuppressants by giving saffron as capsules in two different doses. The investigators will assess whether the addition of saffron will improve the overall patient's status and decrease the need for immunosuppressants. If participants have been prescribed immunosuppressants by the participant's doctor, saffron will be added to the participants' treatment.

• The investigators request that the subject answer as many questions as they can during this visit. If they are unable to complete the questionnaires during this visit, the investigators ask them to please return them within 7 days. If the investigators do not receive the questionnaires, the investigators will make one phone call to remind the subjects to send the questionnaires back.

• The subject medical record and colonoscopy report will be used to determine IBD or health status, the blood sample will be used to assess immune markers (inflammatory and antiinflammatory), stool sample will be used to assess some inflammation markers and saffron effect on the intestinal bacterial composition, a saliva sample will be used to assess whether saffron selectively affects the intestinal bacteria but not the saliva bacteria and the urine sample will be used to assess saffron release in body fluids.

• Participants are being asked to participate in this research project because participants are having a normal colonoscopy for screening, or IBD.

• If a biopsy is taken at colonoscopy. a pathologist will use a portion to make a diagnosis. The investigators are requesting permission to use a portion of the excess tissue that the pathologist does not need, for this research project.

• Samples will be collected at baseline (day 0) and 8 weeks later after saffron capsules utilization.

• This is a double-blind clinical trial, you will not know whether participants are given a placebo (capsule without saffron) or saffron dose 1 or 2. This is important for participants and for the study process, to avoid any psychological effect on the expected saffron effect.

• However, by the end of the 8 weeks and after collecting and analyzing the data from all participants, the investigators will inform the subject of what the subjects were given and potential next steps. ;

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Ulcerative Colitis

• NCT number: NCT05715099
• Study type: Interventional
• Source: Minia University
• Contact: Alshymaa Hassnine, Ass. prof
• Phone: +201092004294
• Email: Alshiamaa.Ahmed@mu.edu.eg
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 30, 2023
• Completion date: July 30, 2023