Clinical Trials Logo
  1. Home
  2. Crohn's Disease
  3. NCT01926730

Food and Crohn's Exacerbation Study (FACES) — FACES  

Crohn's Disease Clinical Trial

Official title:
Food and Crohn's Exacerbation Study (FACES)

Clinical Trial Summary

The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01926730
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date November 2013
Completion date June 2016
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03815851 - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery N/A
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Completed NCT02883452 - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis Phase 1
Recruiting NCT04777656 - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. Phase 3
Terminated NCT03017014 - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Recruiting NCT06053424 - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease Phase 1
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Terminated NCT02882841 - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients N/A
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A
Terminated NCT02417974 - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) Phase 2
Completed NCT03010787 - A First Time in Human Study in Healthy Volunteers and Patients Phase 1
Completed NCT02542917 - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01951326 - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease Phase 3