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NCT02634060: HELP-AID
Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny
NA trial testing Home Based Fecal Calprotectin in Crohn Disease in 140 participants. Completed in 5 September 2022.
1 June 2018
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 140 |
| Start date | 31 March 2016 |
| Primary completion | 1 June 2018 |
| Estimated completion | 5 September 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Home Based Fecal Calprotectin
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
- Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
18 and older, any sex, with Crohn Disease or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD. Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional. In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02634060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
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- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02634060 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 27 June 2024
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