Micronutrient and Additive Modifications May Optimize Diet To Health

NCT05743374 | Recruiting

• 1 other identifier: 2022-01347
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Diet Habit; Microbial Colonization

Keywords

Ulcerative colitis; Diet; Microbiota; Emulsifying agent

Outcome Measures

Primary Outcomes (2)

• Calprotectin

  A protein in faeces that increases when there is a flare of the colitis

  One month

• Microbiota diversity

  The diversity of the GI microbiota reflects disease severity

  One month

Study Arms (2)

Normal diet

OTHER

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

Other: Normal diet

E400 elimination

ACTIVE COMPARATOR

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

Dietary Supplement: E400 elimination

Interventions

Normal diet OTHER

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

Normal diet

E400 elimination DIETARY_SUPPLEMENT

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

E400 elimination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ulcerative colitis,
• Moderately active
• Stable medication

You may not qualify if:

• Severe disease
• Recent surgery
• Proctitis
• Pregancy
• Treatment with antibiotics
• Difficulties in understanding the information about the study
• Multimorbidity that makes it impossible to participate

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Region Skåne

Malmo, Skåne County, 21428, Sweden

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Feeding Behavior; Communicable Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Behavior, Animal; Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klas Sjöberg, Prof

  Dept of Gastroenterology, SUS, Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klas Sjöberg, Prof

CONTACT

+46702372580; klas.sjoberg@med.lu.se

Sanna Davidson, MD

CONTACT

+4640332185; sanna.davidson@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

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

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 26, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)