Saffron as Anti Inflammatory Agent In Patients With Inflammatory Bowel Disease

NCT04749576 | Unknown

• 1 other identifier: HowardU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Nutritional Saffron supplement has been widely used as food supplement and has known anti-depressant and anti-inflammatory activities. It is generally consumed as stigmas in drinks or dishes. The investigators use saffron extract in patients with colitis for 8 weeks.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (9)

• inflammatory markers assessment

  Serum anti-inflammatory and pro-inflammatory markers measures in 8 weeks compared to baseline improving the blood immune marker in the normal range for contributing factors which consist of TNF-α (8.1 pg/mL).IL-1β (\<5 pg/mL), IL-6(5-15 pg/ml)., and IL-10 (4.8-9.8 pg/ml), The units in the parenthesis are the normal range for each marker

  8 weeks

• stool frequency assessment

  will be assessed by decreasing less than 2 per day

  8 week

• stool consistency assessment

  Improvement to median score 4 to normal stool consistency. Bristol score: Improvement in stool consistency measures in 8 weeks in our study compared to baseline (Bristol score: The ideal stool is generally type 3 or 4, easy to pass without being too watery too solid. Type 1 or 2, it is sign of constipation. Types 5, 6, and 7 tend toward diarrhea)

  8 week

• fecal calprotectin assessment

  Decrease in calprotectin levels. Fecal calprotectin normal range to be 10 to 60 μg/mg

  8 weeks

• C reactive protein assessment

  change on C reactive protein level reading is less than 10 milligram per liter

  8 week

• erythrocyte sedimentation rate assessment

  maintaining erythrocyte sedimentation rate with the normal range of 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.

  8 weeks

• Serum Pro-inflammatory assessment

  improving the blood immune marker in the normal range for contributing factors which consist of TNF-α (8.1 pg/mL).IL-1β (\<5 pg/mL), IL-6(5-15 pg/ml)., IL-10 (4.8-9.8 pg/ml), and Th17 (221.6±90.2/µl). The units in the parenthesis are the normal range for each marker

  8 weeks

• Serum Anti-inflammatory assessment

  improve the IL-10 level to at least reach the normal level of ranged from 4.8-9.8 pg/ml

  8 weeks

• The Ulcerative Colitis Colonoscopic Index of Severity scores

  Decrease of 2 or more unit in the Ulcerative Colitis Colonoscopic Index of Severity score. The Ulcerative Colitis Colonoscopic Index of Severity scores for mild colitis is 3-5, and for moderate is 5-9

  8 weeks

Secondary Outcomes (1)

• endoscopy colitis assessment

  8-12 weeks

Study Arms (3)

Low dose saffron

ACTIVE COMPARATOR

healthy, mild-moderate ulcerative colitis for low dose

Dietary Supplement: saffron supplement for IBD

High dose Saffron

ACTIVE COMPARATOR

healthy, mild-moderate ulcerative colitis for high dose

Dietary Supplement: saffron supplement for IBD

Placebo

PLACEBO COMPARATOR

healthy, mild-moderate ulcerative colitis for placebo

Dietary Supplement: saffron supplement for IBD

Interventions

saffron supplement for IBD DIETARY_SUPPLEMENT

anti inflammatory effect

High dose Saffron; Low dose saffron; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged \>18 years
• Have UC diagnosed at least 3 months prior to screening? The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
• Men and women of childbearing potential must agree to use adequate birth control measures during the study.
• Ability to provide written informed consent and to be compliant with the schedule of protocol assessments, treatment plan, laboratory tests, and other study procedures.
• UC patients with mild, mod, severity as assess by the 4 scale assessment (Normal, mild, mod, severe).
• Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
• \. UC patients already on a treatment might be considered, with saffron as an add-on 8. UC patients who displayed no improvement with any available treatment might be considered for saffron as an alternative treatment in this option.

You may not qualify if:

• Patients taking immunosuppressive medicine for a disease other than UC
• Rheumatologic disease and other underlying diseases that can interfere with the study process.
• Pregnancy
• If the UC has been present for \> 10 years, a colonoscopy with biopsy has to be performed to rule-out dysplasia.
• A subject who had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period.
• Subjects with evidence of liver disease or abnormal liver enzymes and function tests (e.g. total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than the upper limit of normal) at the screening visit.
• Subjects who have any condition possibly affecting oral nutritional supplement absorption.
• Patients with known active or untreated GI infections including C. difficile, CMV, HSV, HIV

Sponsors & Collaborators

• Howard University: lead

Study Sites (1)

Howard University Hospital

Washington D.C., District of Columbia, 20059, United States

RECRUITING

Related Publications (1)

• 1 Ghosh S, Mitchell R. Impact of inflammatory bowel disease on quality of life: Results of the European Federation of Crohn's and Ulcerative Colitis Associations (EFCCA) patient survey J Crohns Colitis. 2007;1:10-20. 2 Jess T, Gamborg M, Munkholm P, Sorensen TI. Overall and cause-specific mortality in ulcerative colitis: meta-analysis of population-based inception cohort studies Am J Gastroenterol. 2007;102:609-617. 3 Tanaka T. Colorectal carcinogenesis: Review of human and experimental animal studies J Carcinog. 2009;8:5. 4 Torres J, Burisch J, Riddle M, Dubinsky M, Colombel JF. Preclinical disease and preventive strategies in IBD: perspectives, challenges and opportunities Gut. 2016;65:1061-1069. 5 Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015 MMWR Morb Mortal Wkly Rep. 2016;65:1166-1169. 6 Nguyen DL, Parekh N, Bechtold ML, Jamal MM. National Trends and In-Hospital Outcomes of Adult Patients With Inflammatory Bowel Disease Receiving Parenteral Nutrition Support JPEN J Parenter Enteral Nutr. 2016;40:412-416. 7 Kappelman MD, Rifas-Shiman SL, Porter CQet al. . Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults Gastroenterology. 2008;135:1907-1913. 8 Blakeley-Ruiz JA, Erickson AR, Cantarel BLet al. . Metaproteomics reveals persistent and phylum-redundant metabolic functional stability in adult human gut microbiomes of Crohn's remission patients despite temporal variations in microbial taxa, genomes, and proteomes Microbiome. 2019;7:18. 9 Ashktorab H, Soleimani A, Singh Get al. . Saffron: The Golden Spice with Therapeutic Properties on Digestive Diseases Nutrients. 2019;11. 10 Mashmoul M, Azlan A, Khaza'ai H, Yusof BN, Noor SM. Saffron: A Natural Potent Antioxidant as a Promising Anti-Obesity Drug Antioxidants (Basel). 2013;2:293-308. 11 Hosseinzadeh H, Talebzadeh F. Anticonvulsant evaluation of safranal and crocin from Crocus sativus in mice Fitoterapia. 2005;76:722-724. 12 Hosseinzadeh H, Modaghegh MH, Saffari Z. Crocus sativus L. (Saffron) extract and its active constituents (crocin and safranal) on ischemia-reperfusion in rat skeletal muscle Evid Based Complement Alternat Med. 2009;6:343-350. 13 El-Maraghy SA, Rizk SM, Shahin NN. Gastroprotective effect of crocin in ethanol-induced gastric injury in rats Chem Biol Interact. 2015;229:26-35. 14 Hosseinzadeh H, Sadeghnia HR. Safranal, a constituent of Crocus sativus (saffron), attenuated cerebral ischemia induced oxidative damage in rat hippocampus J Pharm Pharm Sci. 2005;8:394-399. 15 Lee IA, Lee JH, Baek NI, Kim DH. Antihyperlipidemic effect of crocin isolated from the fructus of Gardenia jasminoides and its metabolite Crocetin Biol Pharm Bull. 2005;28:2106-2110. 16 Abdullaev FI, Espinosa-Aguirre JJ. Biomedical properties of saffron and its potential use in cancer therapy and chemoprevention trials Cancer Detect Prev. 2004;28:426-432. 17 Abdullaev FI. Cancer chemopreventive and tumoricidal properties of saffron (Crocus sativus L.) Exp Biol Med (Maywood). 2002;227:20-25. 18 Singh G, Brim H, Ashktorab H, Habtezion A. Protective effect of Saffron in mouse model colitis through immune modulation DDW Gasteroenrology, City;2020. 19 Yoshino F, Yoshida A, Umigai N, Kubo K, Lee MC. Crocetin reduces the oxidative stress induced reactive oxygen species in the stroke-prone spontaneously hypertensive rats (SHRSPs) brain J Clin Biochem Nutr. 2011;49:182-187. 20 Rahaiee S, Moini S, Hashemi M, Shojaosadati SA. Evaluation of antioxidant activities of bioactive compounds and various extracts obtained from saffron (Crocus sativus L.): a review J Food Sci Technol. 2015;52:1881-1888. 21 Hosseinzadeh H, Younesi HM. Antinociceptive and anti-inflammatory effects of Crocus sativus L. stigma and petal extracts in mice BMC Pharmacol. 2002;2:7. . 34 Maleki I, Taghvaei T, Barzin M, Amin K, Khalilian A. Validation of the Persian version of the inflammatory bowel disease questionnaire (IBDQ) in ulcerative colitis patients Caspian J Intern Med. 2015;6:20-24. 35 McGahuey CA, Gelenberg AJ, Laukes CAet al. . The Arizona Sexual Experience Scale (ASEX): reliability and validity J Sex Marital Ther. 2000;26:25-40. 36 Brim H, Yooseph S, Lee Eet al. . A Microbiomic Analysis in African Americans with Colonic Lesions Reveals Streptococcus sp.VT162 as a Marker of Neoplastic Transformation Genes (Basel). 2017;8. 37 Tabtabaei S, D'Archivio AA, Maggi MAet al. . Geographical classification of Iranian and Italian saffron sources based on HPLC analysis and UV-Vis spectra of aqueous extracts Eur Food Res Technol. 2019;245:2435-2446.

  RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hassan Ashktorab

  Howard Uinversity

  STUDY CHAIR

Central Study Contacts

Hassan Ashktorab

CONTACT

2028066121; hashktorab@howard.edu

Hassan Brim

CONTACT

2028064198; hbrim@howard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both patients and care provider does not know whether the participant receiving placebo or saffron
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomize double placebo

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: February 11, 2021
• Study Start: December 15, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2023
• Last Updated: February 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)