A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Relapse in Patients With IBD

NCT04079335 | Unknown DMC

• 1 other identifier: IBD MiREL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural course of IBD is characterized by activity outbreaks and periods of remission. In most cases, relapses in Crohn's disease (CD) and in ulcerative colitis (UC) are unpredictable and despite effective medical treatment, a degree of subclinical inflammation may persist in the bowel wall, contributing to a significant risk of relapse. In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members. It is however unclear whether changes in microbial profile including diversity and composition can predict disease relapse in IBD. We hypothesize that fecal microbial signatures in conjunction with fecal calprotectin may play a role in predicting relapse in IBD patients.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Clinical relapse for CD patients

  Defined as worsening of the symptoms, accompanied by HBI score of ≥ 8 points for CD and require a change in therapy.

  2 years

• Clinical relapse for UC patients

  Defined as partial Mayo score of ≥ 5 points for UC and require a change in therapy.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD patients who visit Prince of Wales Hospital in Hong Kong

You may qualify if:

• Patient with Crohn's Disease
• Aged ≥18 years old
• Confirmed diagnosis of ileo-colonic Crohn's disease according to established clinical, endoscopic and histologic criteria
• History of at least one flare with symptoms that required intervention within 24 months before screening
• Stable doses of immunosuppressive agents for at least 3 months if these agents are required
• In clinical remission for at least 3 months, defined as Harvey Bradshaw Index (HBI) score \< 4
• Written informed consent obtained
• Patient with Ulcerative Colitis
• Aged ≥18 years old
• Have a confirmed diagnosis of ulcerative colitis according to established clinical, endoscopic and histologic criteria
• History of at least one flare with symptoms that required intervention within 24 months before screening
• On stable regimen of 5-ASA for at least 3 months
• In clinical remission for at least 3 months defined as partial Mayo score ≤ 1
• Written informed consent obtained

You may not qualify if:

• Previous bowel surgery /stoma
• On anti-TNF therapy
• Malignant disease within 5 years
• Use of probiotics, prebiotics or antibiotics in past 3 months
• Terminal illness

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (6)

• Garcia-Sanchez V, Iglesias-Flores E, Gonzalez R, Gisbert JP, Gallardo-Valverde JM, Gonzalez-Galilea A, Naranjo-Rodriguez A, de Dios-Vega JF, Muntane J, Gomez-Camacho F. Does fecal calprotectin predict relapse in patients with Crohn's disease and ulcerative colitis? J Crohns Colitis. 2010 Jun;4(2):144-52. doi: 10.1016/j.crohns.2009.09.008. Epub 2009 Dec 2.

  PMID: 21122498 BACKGROUND

• Hanaway P, Roseth A. Inflammatory biomarkers predict relapse in IBD. Gut. 2005 Sep;54(9):1346-7. doi: 10.1136/gut.2005.070615. No abstract available.

  PMID: 16099806 BACKGROUND

• Sartor RB, Wu GD. Roles for Intestinal Bacteria, Viruses, and Fungi in Pathogenesis of Inflammatory Bowel Diseases and Therapeutic Approaches. Gastroenterology. 2017 Feb;152(2):327-339.e4. doi: 10.1053/j.gastro.2016.10.012. Epub 2016 Oct 18.

  PMID: 27769810 BACKGROUND

• McIlroy J, Ianiro G, Mukhopadhya I, Hansen R, Hold GL. Review article: the gut microbiome in inflammatory bowel disease-avenues for microbial management. Aliment Pharmacol Ther. 2018 Jan;47(1):26-42. doi: 10.1111/apt.14384. Epub 2017 Oct 16.

  PMID: 29034981 BACKGROUND

• Pascal V, Pozuelo M, Borruel N, Casellas F, Campos D, Santiago A, Martinez X, Varela E, Sarrabayrouse G, Machiels K, Vermeire S, Sokol H, Guarner F, Manichanh C. A microbial signature for Crohn's disease. Gut. 2017 May;66(5):813-822. doi: 10.1136/gutjnl-2016-313235. Epub 2017 Feb 7.

  PMID: 28179361 BACKGROUND

• D'Haens G, Ferrante M, Vermeire S, Baert F, Noman M, Moortgat L, Geens P, Iwens D, Aerden I, Van Assche G, Van Olmen G, Rutgeerts P. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2218-24. doi: 10.1002/ibd.22917. Epub 2012 Feb 16.

  PMID: 22344983 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph JY Sung, Prof

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Ching

CONTACT

+852 35053524; jessicaching@cuhk.edu.hk

Alicia Chan

CONTACT

+852 26373260; aliciachan@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profressor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: January 28, 2019
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

HK (1)