Micronutrient and Additive Modifications May Optimize Diet To Health

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Microbial Colonization; Diet Habit
• Interventions: Dietary Supplement: E400 elimination; Other: Normal diet

• Registration Number: NCT05743374
• Lead Sponsor: Region Skane

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Status Verified: 2024-04
• Study Start: 2024-04-02
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E400 elimination	E400 elimination	The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.
Normal diet	Normal diet	One arm will be given dietary advice that is always given to patients with ulcerative colitis.

Primary Outcome Measures

Name	Time	Method
Calprotectin	One month	A protein in faeces that increases when there is a flare of the colitis
Microbiota diversity	One month	The diversity of the GI microbiota reflects disease severity

Trial Locations

Locations (1)

Region Skåne; 🇸🇪 Malmö, Skåne, Sweden