NCT05743374

Micronutrient and Additive Modifications May Optimize Diet To Health

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Ulcerative Colitis
• Diet Habit
• Microbial Colonization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-02
• Primary completion: 2029-06-26
• Completion: 2029-12-31
• First posted: 2023-02-24
• Last updated: 2026-01-12

Locations

1 site across 1 country: Sweden