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Biologics and Partial Enteral Nutrition Study

Study acronym: BIOPIC
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated November 30, 2021 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Nov 2021); last known: Recruiting
  2. Minor Study sites revised (4)v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 4
    • Primary and study completion dates: Jul 2026 to Sep 2026
    • Start date changed from estimate of Jul 2021 to Sep 20, 2021
    v3
  4. Minor Secondary endpoints: 19 to 18
    • Study description expanded, about 1 word
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers. Two of the best treatments currently used in people with CD are drug injections and/or infusions (biologics), and a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 40% of the patients, and although treatment with the liquid-only diet has a better safety and effectiveness profile, it is difficult for patients to stick to this as their sole source of nutrition for 6-8 weeks, particularly for adults. BIOPIC study aims to investigate whether replacing half of a habitual diet with specialised milkshakes will improve response to standard treatment with biologics in adults with CD.
Trial Details
NCT Number NCT04859088
Lead Sponsor NHS Greater Glasgow and Clyde
Collaborators: University of Glasgow
Conditions
(from sponsor)
Crohn Disease
Related terms Crohn Disease, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov