Clinical trial NCT05117749: Saffron and Ulcerative Colitis
Official title: The Effect of Saffron in Patients With Ulcerative Colitis: A Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: saffron
Ulcerative Colitis
inflammatory bowel disease
randomized double-blind clinical trial
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo.
Primary purpose: TREATMENT

Brief summary: IBD is a chronic disease with two major types of Crohn's Disease (CD) and Ulcerative Colitis (UC). Nowadays, synthetic drugs and monoclonal antibodies are the most common types of drugs used for IBD management. However, due to their side effects and the high relapse rate, many researchers are looking for plant-derived products to manage the disease. Saffron, Crocus sativus L., is widely used as spice and medicine with anti-obesity, anticonvulsant, anti-hyperlipidemic, anti-tumor, antioxidant, and anti-inflammatory properties. Besides, there is evidence of the favorable effects of saffron on the gut microbiome. The main aim of this proposal is to evaluate the effect of saffron as a complementary supplement or add-on therapy in combination with current therapeutic agents in patients with mild and moderate UC.

Detailed description: This study will be a parallel, randomized, double-blinded clinical trial assessing the efficacy of the saffron extract compared to placebo in patients with mild and moderate UC. Sixty eligible patients will be recruited and randomized into 6 groups to receive either saffron capsule or placebo. Randomization will be performed by an independent researcher (AAK) who is not directly involved in the trial and using software-generated random permuted blocks. Allocation concealment will be also conducted using sealed, opaque envelopes with consecutive numbering. The saffron and placebo will be provided free of charge by Sina Pajoohan Salamat co, Mashhad, Iran. The standard treatment will be administered to all patients as recommendations of the physicians.

Intervention

The intervention groups of study will be included:

1. Mild UC patients, receiving100 milligram (mg)/day saffron for 8 weeks (50 mg two times (BID)), n=10
2. Moderate UC patients, receiving100 mg/day saffron for 8 weeks (50 mg BID), n=10
3. Mild UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
4. Moderate UC patients, receiving 50 mg/day saffron for 8 weeks (25 mg BID), n=10
5. Mild UC patients, receiving 2 tablets of placebo for 8 weeks, n=10
6. Moderate UC patients, receiving 2 tablets of placebo for 8 weeks, n=10

Demographic and baseline characteristics will be recorded, and assessment of anthropometric and biochemical parameters, fecal calprotectin, inflammatory cytokines, stool microbiome, and its transcriptomic, and metabolomic, urine and saliva metabolomics, health-related quality of life (HRQoL), anxiety, and disease severity will be done at baseline and after 8 weeks. Fecal calprotectin, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and disease severity will also be evaluated at 4th week. Moreover, HRQoL and anxiety will also be examined after 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients between 18-80 years' old
2. Patients who have received a diagnosis of UC at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
3. Patients with the ability to give written informed consent and to be compliant with the schedule of intervention and assessments
4. Patients with mild (3-5) or moderate (6-11) UC, according to the Simple Clinical Colitis Activity Index

Exclusion Criteria:

1. Pregnant patients or those planning pregnancy
2. Patients receiving immunosuppressive agents for diseases other than UC
3. Patients with confirmed cancer, dysplasia, autoimmune, and rheumatology diseases
4. Patients who had surgery for UC treatment
5. Individuals with liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) at the screening visit
6. Patients who have any condition affecting oral drug absorption.
7. Subjects with known active or untreated GI infections including C.diff, CMV, HSV, HIV
8. Subjects with clinical features of CD; history of CD (Crohns colitis, or Ileo-colitis), clinical signs of fulminant colitis, toxic megacolon, or Microscopic Colitis, indeterminate Colitis, infectious Colitis, or ischemic colitis

Primary outcomes:
measure: Changes in clinical response
timeFrame: 4 and 8 weeks
measure: Changes in the fecal calprotectin level
timeFrame: 4 and 8 weeks
measure: Changes in the serum levels of CRP
timeFrame: 4 and 8 weeks
measure: Changes in the serum levels of ESR
timeFrame: 4 and 8 weeks
Secondary outcomes:
measure: Changes in the serum anti-inflammatory and pro-inflammatory markers
timeFrame: 8 week
measure: Changes in the Health-related quality of life (HRQoL )
timeFrame: 8, 24, and 48 weeks
measure: Changes in the stool microbiome and transcriptome
timeFrame: 8 week
measure: Safety assessment (Incidence of Treatment-Emergent Adverse Events)
timeFrame: 8 week
measure: Changes in the anxiety
timeFrame: 8, 24, and 48 weeks
measure: Changes in the metabolomic profile of urine, stool, and saliva
timeFrame: 8 weeks
Other outcomes:
Locations:
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