Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05743374

Micronutrient and Additive Modifications May Optimize Diet To Health for Moderately Active Ulcerative Colitis

Led by Region Skane · Updated on 2026-01-12

70

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of dietary changes on patients with moderately active ulcerative colitis. This prospective clinical trial compares a normal healthy diet to a diet that eliminates specific emulsifying agents, particularly carrageenan, CMC, and polysorbates, which are part of the E 400 additive group. The goal is to see if removing these additives can improve disease activity and the gut microbiota. Participants are randomly assigned to one of two groups: one group receives standard dietary advice for ulcerative colitis, while the other group receives advice to eliminate E400 additives from their diet. Diets are recorded at the beginning and after one month using a food diary and a food frequency questionnaire focused on E400 intake. Clinical characteristics, disease activity markers like diarrhea frequency, blood in stools, abdominal pain, CRP, calprotectin, and microbiota samples are collected and analyzed. During the study, participants will have their diets and clinical status assessed at the start and after one month. Researchers will measure outcomes including calprotectin levels and microbiota diversity to evaluate disease activity and gut health. The study includes monitoring of clinical symptoms and microbiota composition using advanced sequencing methods. Participation involves diet recording and clinical assessments over a one-month period to track changes and safety.

CONDITIONS

Brief Title

Micronutrient and Additive Modifications May Optimize Diet To Health

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of ulcerative colitis
  • Moderately active disease
  • Stable medication for ulcerative colitis
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Severe ulcerative colitis
  • Recent surgery
  • Proctitis
  • Pregnancy
  • Treatment with antibiotics
  • Difficulty understanding study information
  • Multiple health conditions preventing participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 month

Participants follow assigned dietary advice to either maintain a normal diet or eliminate E400 additives, with clinical characteristics and diet recorded at the start and end of the treatment period.

2 visits (in-person) including diet recording and clinical assessments

Trial Site Locations

Total: 1 location

1

Region Skåne

Malmö, Skåne County, Sweden, 21428

Actively Recruiting

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Research Team

K

Klas Sjöberg, Prof

S

Sanna Davidson, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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