Nutrition and Clinical Outcomes in IBD

NCT06550310 | Recruiting

• 1 other identifier: 337108
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to demonstrate that nutritional status and body composition have an impact on clinical outcomes in inflammatory bowel disease (IBD). The main objectives are:

1. 1.To compare the detection rates of undernutrition between a range of nutritional screening tools, physiological measures and assessment tools amongst patients with different IBD phenotypes
2. 2.To correlate nutritional status, nutritional biomarkers and body composition with clinical outcomes in patients with IBD treated with advanced medical therapy or surgery
3. 3.To determine a potential relationship between radiological muscle mass measurements and clinical outcomes in patients with IBD treated with advanced medical therapy or surgery

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Malnutrition; Sarcopenia

Keywords

Body composition; Nutritional status; Nutritional markers; Nutritional screening tools; Nutritional assessment; Sarcopenia; Radiological muscle mass; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (2)

• Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).

  Clinical outcomes are as follows clinical response, clinical and biochemical remission, corticosteroid use, therapy switch or IBD related-surgery. Clinical response in UC is defined as a ≥2-point and ≥30% decrease from baseline in partial Mayo score and a ≥1-point decrease from baseline in rectal bleeding sub-score or an absolute rectal bleeding sub-score ≤1. Clinical response in CD is defined as ≥ 3 points decrease of HBI score. Clinical remission is defined as a partial Mayo score of 0-1 in UC or HBI of ≤4 in CD. Biochemical remission is defined as faecal calprotectin \<200μg/mg and CRP ≤5mg/L.

  14 and 52 weeks

• Correlation of nutritional parameters (at baseline and during treatment) with pre-defined clinical outcomes in patients undergoing IBD-related surgery (at 30 and 90 days).

  Clinical outcomes are defined as length of post-operative stay, formation of unplanned stoma, 30-day complication rate, 30-day complication grade (defined by the Clavien-Dindo scale) and 90-day readmission rate.

  30 and 90 days

Secondary Outcomes (2)

• Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced medical therapy (at 14 and 52 weeks).

  14 and 52 weeks

• Correlation of currently used radiological muscle mass thresholds with pre-defined clinical outcomes in patients undergoing advanced IBD-related surgery (at 30 and 90 days).

  30 and 90 days

Study Arms (2)

Medical treatment group

Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy (e.g. biologic or small molecule)

Surgical treatment group

Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults (\>16) with a diagnosis of inflammatory bowel disease (IBD) attending a tertiary IBD centre who are undergoing a new treatment or change in treatment, or an operation for their condition

You may qualify if:

• Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) starting a new advanced medical therapy
• Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis or IBD-U) undergoing an IBD-related surgery
• Age \>16
• Patients able and willing to provide written informed consent

You may not qualify if:

• Patients below the age of 16
• Patients who cannot provide informed consent
• Patients with a cardiac pacemaker or internal defibrillator
• Patients with active cancer and other disorders associated with severe cachexia

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

Barts Health NHS Trust

London, N15 4GL, United Kingdom

RECRUITING

Related Publications (15)

• GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.

  PMID: 31648971 BACKGROUND

• Knowles SR, Graff LA, Wilding H, Hewitt C, Keefer L, Mikocka-Walus A. Quality of Life in Inflammatory Bowel Disease: A Systematic Review and Meta-analyses-Part I. Inflamm Bowel Dis. 2018 Mar 19;24(4):742-751. doi: 10.1093/ibd/izx100.

  PMID: 29562277 BACKGROUND

• Lewis RT, Maron DJ. Efficacy and complications of surgery for Crohn's disease. Gastroenterol Hepatol (N Y). 2010 Sep;6(9):587-96.

  PMID: 21088749 BACKGROUND

• Gklavas A, Dellaportas D, Papaconstantinou I. Risk factors for postoperative recurrence of Crohn's disease with emphasis on surgical predictors. Ann Gastroenterol. 2017;30(6):598-612. doi: 10.20524/aog.2017.0195. Epub 2017 Sep 26.

  PMID: 29118554 BACKGROUND

• Ma C, Moran GW, Benchimol EI, Targownik LE, Heitman SJ, Hubbard JN, Seow CH, Novak KL, Ghosh S, Panaccione R, Kaplan GG. Surgical Rates for Crohn's Disease are Decreasing: A Population-Based Time Trend Analysis and Validation Study. Am J Gastroenterol. 2017 Dec;112(12):1840-1848. doi: 10.1038/ajg.2017.394. Epub 2017 Oct 31.

  PMID: 29087396 BACKGROUND

• Ananthakrishnan AN, Shi HY, Tang W, Law CC, Sung JJ, Chan FK, Ng SC. Systematic Review and Meta-analysis: Phenotype and Clinical Outcomes of Older-onset Inflammatory Bowel Disease. J Crohns Colitis. 2016 Oct;10(10):1224-36. doi: 10.1093/ecco-jcc/jjw054. Epub 2016 Feb 29.

  PMID: 26928965 BACKGROUND

• Nguyen GC, Munsell M, Harris ML. Nationwide prevalence and prognostic significance of clinically diagnosable protein-calorie malnutrition in hospitalized inflammatory bowel disease patients. Inflamm Bowel Dis. 2008 Aug;14(8):1105-11. doi: 10.1002/ibd.20429.

  PMID: 18302272 BACKGROUND

• Ananthakrishnan AN, McGinley EL, Binion DG, Saeian K. A novel risk score to stratify severity of Crohn's disease hospitalizations. Am J Gastroenterol. 2010 Aug;105(8):1799-807. doi: 10.1038/ajg.2010.105. Epub 2010 Mar 9.

  PMID: 20216534 BACKGROUND

• Ciocirlan M, Ciocirlan M, Iacob R, Tantau A, Gheorghe L, Gheorghe C, Dobru D, Constantinescu G, Cijevschi C, Trifan A, Goldis A, Diculescu M. Malnutrition Prevalence in Newly Diagnosed Patients with Inflammatory Bowel Disease - Data from the National Romanian Database. J Gastrointestin Liver Dis. 2019 Jun 1;28:163-168. doi: 10.15403/jgld-176.

  PMID: 31204412 BACKGROUND

• Casanova MJ, Chaparro M, Molina B, Merino O, Batanero R, Duenas-Sadornil C, Robledo P, Garcia-Albert AM, Gomez-Sanchez MB, Calvet X, Trallero MDR, Montoro M, Vazquez I, Charro M, Barragan A, Martinez-Cerezo F, Megias-Rangil I, Huguet JM, Marti-Bonmati E, Calvo M, Campdera M, Munoz-Vicente M, Merchante A, Avila AD, Serrano-Aguayo P, De Francisco R, Hervias D, Bujanda L, Rodriguez GE, Castro-Laria L, Barreiro-de Acosta M, Van Domselaar M, Ramirez de la Piscina P, Santos-Fernandez J, Algaba A, Torra S, Pozzati L, Lopez-Serrano P, Arribas MDR, Rincon ML, Pelaez AC, Castro E, Garcia-Herola A, Santander C, Hernandez-Alonso M, Martin-Noguerol E, Gomez-Lozano M, Monedero T, Villoria A, Figuerola A, Castano-Garcia A, Banales JM, Diaz-Hernandez L, Arguelles-Arias F, Lopez-Diaz J, Perez-Martinez I, Garcia-Talavera N, Nuevo-Siguairo OK, Riestra S, Gisbert JP. Prevalence of Malnutrition and Nutritional Characteristics of Patients With Inflammatory Bowel Disease. J Crohns Colitis. 2017 Dec 4;11(12):1430-1439. doi: 10.1093/ecco-jcc/jjx102.

  PMID: 28981652 BACKGROUND

• Bamba S, Sasaki M, Takaoka A, Takahashi K, Imaeda H, Nishida A, Inatomi O, Sugimoto M, Andoh A. Sarcopenia is a predictive factor for intestinal resection in admitted patients with Crohn's disease. PLoS One. 2017 Jun 23;12(6):e0180036. doi: 10.1371/journal.pone.0180036. eCollection 2017.

  PMID: 28644887 BACKGROUND

• Zhang T, Cao L, Cao T, Yang J, Gong J, Zhu W, Li N, Li J. Prevalence of Sarcopenia and Its Impact on Postoperative Outcome in Patients With Crohn's Disease Undergoing Bowel Resection. JPEN J Parenter Enteral Nutr. 2017 May;41(4):592-600. doi: 10.1177/0148607115612054. Epub 2015 Oct 15.

  PMID: 26471990 BACKGROUND

• Pedersen M, Cromwell J, Nau P. Sarcopenia is a Predictor of Surgical Morbidity in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Oct;23(10):1867-1872. doi: 10.1097/MIB.0000000000001166.

  PMID: 28604415 BACKGROUND

• Peng P, Hyder O, Firoozmand A, Kneuertz P, Schulick RD, Huang D, Makary M, Hirose K, Edil B, Choti MA, Herman J, Cameron JL, Wolfgang CL, Pawlik TM. Impact of sarcopenia on outcomes following resection of pancreatic adenocarcinoma. J Gastrointest Surg. 2012 Aug;16(8):1478-86. doi: 10.1007/s11605-012-1923-5. Epub 2012 Jun 13.

  PMID: 22692586 BACKGROUND

• Lomer MC, Gourgey R, Whelan K. Current practice in relation to nutritional assessment and dietary management of enteral nutrition in adults with Crohn's disease. J Hum Nutr Diet. 2014 Apr;27 Suppl 2:28-35. doi: 10.1111/jhn.12133. Epub 2013 Jun 13.

  PMID: 23763616 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Shameer Mehta, MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Faloon, MBChB

CONTACT

07713444631; sarah.faloon@nhs.net

Shameer Mehta, MD

CONTACT

020 3594 3500; shameer.mehta@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 13, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)