Micronutrient and Additive Modifications May Optimize Diet To Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Patients with ulcerative colitis attending the out-patient clinic at Skåne university hospital with calprotectin 100-600 will be invited to participate in this diet intervention study. They will be divided into two arms with 35 patients in each, normal diet or E-400 elimination. The diet will be recorded at study start and end with a food diary for four days and a food frequency questionnaire regarding E-400 intake. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded and microbiota collectted. The hypotheses are that the activity measured with clinical characteristics and calprotectin as well as their microboita measured with dysbiosis index and total genom with NGS will improve significantly.

Conditions

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Ulcerative Colitis Diet Habit Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized intervention study with elimination of putatively harmful substances in the diet

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Although the patients know that they will be given dietary advice they will not know what type of intervention the other group will be offered. Since dietary advice must be given by the investigators the study cannot be blinded to them.

Study Groups

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Normal diet

One arm will be given dietary advice that is always given to patients with ulcerative colitis.

Group Type OTHER

Normal diet

Intervention Type OTHER

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

E400 elimination

The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.

Group Type ACTIVE_COMPARATOR

E400 elimination

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Normal diet

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

Intervention Type OTHER

E400 elimination

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No