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NCT Number: NCT05743374

Micronutrient and Additive Modifications May Optimize Diet To Health

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.

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Key information

Conditions

Ulcerative Colitis Behavior Behavior, Animal Colitis Colitis, Ulcerative Colonic Diseases Communicable Diseases Diet Habit Digestive System Diseases Disease Attributes Feeding Behavior Gastroenteritis Gastrointestinal Diseases Infections Inflammatory Bowel Diseases Intestinal Diseases Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Diet

Other

These patients will be given advice about a normal healthy 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.

Primary outcomes

  1. Calprotectin

    Time frame: One month

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

  2. Microbiota diversity

    Time frame: One month

    The diversity of the GI microbiota reflects disease severity

Study contacts

Contact information is provided by the study sponsor or research team.

Klas Sjöberg, Prof

CONTACT

[email protected]

+46702372580

Sanna Davidson, MD

CONTACT

[email protected]

+4640332185

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: Mammoth

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Feb 24, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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