Micronutrient and Additive Modifications May Optimize Diet To Health (Mammoth)

Region Skane

Status: Enrolling

Conditions: Microbial Colonization; Diet Habit; Ulcerative Colitis

Treatments: Other: Normal diet; Dietary Supplement: E400 elimination

Study type: Interventional

Funder types: Other

Identifiers

NCT05743374

2022-01347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Normal diet

Other group

Description:

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

Treatment:

Other: Normal diet

E400 elimination

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: E400 elimination