Trial · NCT06309472
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment feasibility | Up to 2 years | Participants randomised overall, percentage of target |
| Primary | Trial adherence | 12 weeks | Percentage of participants completing 12 weeks of treatment |
| Primary | Treatment adherence | 12 weeks | Percentage of participants taking at least 75% of prescribed mediation |
| Primary | Study procedures acceptability and compliance | 12 weeks | Percentage of planned data and samples collected at primary endpoint (12 weeks) |
| Primary | Overall acceptability | 12 weeks | Percentage of participants describing the treatment as acceptable (≥6/10 on 0-10 scale) |
| Secondary | Quick Inventory for Depressive Symptomatology-16 Questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-27, higher scores indicate worse depressive symptoms |
| Secondary | Patient Health Questionnaire-9 questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-27, higher scores indicate worse depressive symptoms |
| Secondary | Generalised Anxiety Disorder-7 questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-21, higher scores indicate worse anxiety symptoms |
| Secondary | Inflammatory Bowel Disease Control questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-16, higher scores indicate better self-report IBD control |
| Secondary | Inflammatory Bowel Disease Fatigue Assessment Scale | Baseline, 4, 8, 12 and 16 weeks | Range 0-20, higher scores indicate worse fatigue severity |
| Secondary | Chalder Fatigue Scale | Baseline, 4, 8, 12 and 16 weeks | Range 0-11, higher scores indicate worse fatigue severity |
| Secondary | Maudsley 3-item Visual Analogue Scale | Baseline, 4, 8, 12 and 16 weeks | Range 0-300, higher scores indicate worse depressive symptoms |
| Secondary | Pittsburgh Sleep Quality Index | 4, 8, 12 and 16 weeks | Range 0-21, higher scores indicate worse sleep |
| Secondary | 9-item Avoidant Restrictive Food Intake Disorder Screen | Baseline, 4, 8, 12 and 16 weeks | Range 0-45, higher scores indicate worse symptoms |
| Secondary | Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-100, higher scores indicate worse gastrointestinal symptoms |
| Secondary | Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts | Baseline, 4, 8, 12 and 16 weeks | Higher number of healthcare contacts indicates worse outcome. No minimum or maximum values |
| Secondary | Birmingham Irritable Bowel Syndrome Symptoms Questionnaire | Baseline, 4, 8, 12 and 16 weeks | Range 0-55, higher scores indicate worse symptoms |
| Secondary | Harvey Bradshaw Index (Crohn's disease patients only) | Baseline and 12 weeks | No upper limit. Higher scores indicate worse disease, specifically: Remission: \<5, Mild Disease: 5-7, Moderate Disease: 8-16, Severe Disease: \>16 |
| Secondary | Simple Clinical Colitis Activity Index (ulcerative colitis patients only) | Baseline and 12 weeks | Range 0-19, higher scores indicate worse symptoms |
| Secondary | Dietary Screener Questionnaire | Baseline and 12 weeks | No maximum value, higher scores indicate increased dietary content |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT06309472/registered