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

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.

Study Overview

• Status: Recruiting
• Conditions: Microbial Colonization; Ulcerative Colitis; Diet Habit
• Intervention / Treatment: Other: Normal diet; Dietary supplement: E400 elimination

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klas Sjöberg, Prof; Phone Number: +46702372580; Email: klas.sjoberg@med.lu.se
• Study Contact Backup: Name: Sanna Davidson, MD; Phone Number: +4640332185; Email: sanna.davidson@med.lu.se

Study Locations

• Sweden
  • Skåne County
    • Malmo, Skåne County, Sweden, 21428
      • Recruiting
      • Region Skane
      • Contact: Klas Sjöberg, Prof; Phone Number: +46702372580; Email: klas.sjoberg@med.lu.se
      • Contact: Sanna Davidson, MD; Phone Number: +4640332185; Email: sanna.davidson@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal diet; One arm will be given dietary advice that is always given to patients with ulcerative colitis.	Other: Normal diet; These patients will be given advice about a normal healthy diet.
Active Comparator: E400 elimination; The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Klas Sjöberg, Prof, Dept of Gastroenterology, SUS, Malmö, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): June 26, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Microbiota; Diet; Ulcerative colitis; Emulsifying agent
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal; Colitis, Ulcerative; Communicable Diseases; Feeding Behavior
• Other Study ID Numbers: 2022-01347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will be decided based upon cooperation status

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No