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NCT06552156: FOAM
FOod Additives on the Mucosal Barrier
NA trial testing Dietary Emulsifier in Healthy in 60 participants. Completed in 13 June 2023.
13 June 2023
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 1 November 2022 |
| Primary completion | 13 June 2023 |
| Estimated completion | 13 June 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Dietary Emulsifier
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a 6-week pilot study in 60 healthy volunteers to explore (1) the effect of an emulsifier-free diet (2) the effect of three dietary emulsifiers which are believed to detrimentally affect human health, (3) and the effect of two neutral alternatives (native rice starch and soy lecithin), compared to placebo on intestinal permeability and inflammation, systemic inflammation, and the gut microbiota.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dietary Carrageenan Amplifies the Inflammatory Profile, but not Permeability, of Intestinal Epithelial Cells from Patients With Crohn's Disease.
Vissers E, Wellens J, Giorio L, Zadora W, et al · · 2025 · cited 5× · PMID 39720875 · DOI 10.1093/ibd/izae306 -
Effect of Five Dietary Emulsifiers on Inflammation, Permeability, and the Gut Microbiome: A Placebo-controlled Randomized Trial.
Wellens J, Vanderstappen J, Hoekx S, Vissers E, et al · · 2026 · cited 2× · PMID 40816342 · DOI 10.1016/j.cgh.2025.08.005 -
Feasibility assessment of an emulsifier-free diet in healthy subjects - A sub-analysis of the FOAM trial.
Wellens J, Luppens M, Hoekx S, Vanderstappen J, et al · · 2026 · PMID 42105859 · DOI 10.1016/j.clnesp.2026.103321
Verify or expand the search:
- PubMed search for NCT06552156
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06552156 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 13 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06552156.
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