Micronutrient and Additive Modifications May Optimize Diet To Health

Ulcerative Colitis Clinical Trial

— Mammoth  

Official title:

Micronutrient and Additive Modifications May Optimize Diet To Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743374
• Other study ID #: 2022-01347
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Klas Sjöberg, Prof
• Phone: +46702372580
• Email: klas.sjoberg[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Communicable Diseases
• Diet Habit
• Infections
• Microbial Colonization
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Region Skåne	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calprotectin	A protein in faeces that increases when there is a flare of the colitis	One month
Primary	Microbiota diversity	The diversity of the GI microbiota reflects disease severity	One month