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Clinical Trials/ACTRN12624000916549
ACTRN12624000916549
Not yet recruiting
未知

Investigating a novel therapeutic diet on food additives for ulcerative colitis in adults - The INNOVATE Study

Alfred Health0 sites32 target enrollmentJuly 29, 2024
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Conditionslcerative ColitisUlcerative ColitisOral and Gastrointestinal - Inflammatory bowel disease

Overview

Phase
未知
Intervention
Not specified
Conditions
lcerative Colitis
Sponsor
Alfred Health
Enrollment
32
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 29, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •mild to moderate ulcerative colitis
  • •\- active disease (either left\-sided or extensive UC) as evidenced sonographically, faecal calprotectin \>250 and where available, endoscopy results performed in the last 3 months indicate total Mayo score of 3\-10
  • •\- on stable medical therapy for \>1 month
  • •\- naïve to formal dietetic intervention

Exclusion Criteria

  • •\- Severe UC, indeterminate colitis or Crohn’s disease
  • •\- Presence of other GI co\-morbidities (e.g. coeliac disease)
  • •\- Presence of clinically significant haematological abnormalities
  • •\- Prior gastrointestinal surgeries
  • •\- Pregnancy, trying to get pregnant and breastfeeding
  • •\- Current use of corticosteroids
  • •\- Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g. food allergy, veganism, lacto\-ovo vegetarianism)
  • •\- Individuals not on a stable diet for at least 4 weeks

Outcomes

Primary Outcomes

Not specified

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