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Preventing postoperative relapse of Crohn's disease by using IgG4 guided exclusion diets

Preventing postoperative relapse of Crohn's disease by using IgG4 guided exclusion diets: A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN68739743
Enrollment
50
Registered
2013-02-15
Start date
2013-03-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease Digestive System Crohn disease, unspecified

Interventions

This will be a randomised controlled study. Patients will be enrolled for the study preoperatively. Patients will be invited to participate at the first available opportunity following the decision to

Sponsors

St George's University of London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with histological diagnosis of Crohn's disease 2. Patients who needed surgery for Crohn's disease 3. Patients who agreed to dietary therapy for a minimum of 1 year or until relapse 4. Patients aged 16 and over 5. Patients capable of providing informed consent

Exclusion criteria

Exclusion criteria: 1. Severe disease unrelated to Crohn's disease like chronic renal failure or chronic liver disease or immunological disorders 2. Disease localised perineum 3. Other inflammatory conditions of bowel including Ulcerative colitis

Design outcomes

Primary

MeasureTime frame
1. Relapse over a 1 year period defined by Rutgeerts endoscopic severity score of i2, i3 or i4 2. Crohn's Disease Activity Index (CDAI) >150 or CDAI increase of more than 100 over baseline 3. Need for therapy to induce remission

Secondary

MeasureTime frame
Improvement in quality of life, measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026