Micronutrient and Additive Modifications May Optimize Diet To Health
Not applicable · Testing Normal diet and E400 elimination · 1 site · Region Skane
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Normal diet and E400 elimination (a dietary supplement). Condition(s) listed: Ulcerative Colitis, Diet Habit and Microbial Colonization.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Ulcerative colitis,
- Moderately active
- Stable medication
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2024-04-02.
- Main results expected around 2029-06-26 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Sweden.
Main thing being measured
- Calprotectin (One month)
In the researchers’ words
This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Diet Habit; Microbial Colonization |
| Lead sponsor | Region Skane |
| Enrollment | 70 (estimated) |
| Start date | 2024-04-02 |
| Primary completion (est.) | 2029-06-26 |
| First posted | 2023-02-24 |
| Last updated | 2026-01-12 |
| Official title | Micronutrient and Additive Modifications May Optimize Diet To Health |
| ClinicalTrials.gov ID | NCT05743374 |
Interventions
- Normal diet (Other)
These patients will be given advice about a normal healthy diet. - E400 elimination (Dietary Supplement)
Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
Full eligibility criteria (from the record)
Inclusion Criteria: * Ulcerative colitis, * Moderately active * Stable medication Exclusion Criteria: * Severe disease * Recent surgery * Proctitis * Pregancy * Treatment with antibiotics * Difficulties in understanding the information about the study * Multimorbidity that makes it impossible to participate
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Region Skåne | Malmö, Skåne County | Sweden | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.