Micronutrient and Additive Modifications May Optimize Diet To Health

NCT05743374 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-12

No results posted yet for this study

Summary

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. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.

Conditions

Interventions

OTHER

Normal diet

These patients will be given advice about a normal healthy diet.

DIETARY_SUPPLEMENT

E400 elimination

Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Klas Sjöberg, Prof · Dept of Gastroenterology, SUS, Malmö, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2029-06-26
Completion
2029-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743374 on ClinicalTrials.gov