Ulcerative ColitisMammothNCT05743374
Micronutrient and Additive Modifications May Optimize Diet To Health
A study testing Normal diet and E400 elimination in people with Ulcerative Colitis and Diet Habit, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Diet Habit, Microbial Colonization
- What is being tested?
- Normal diet and E400 elimination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 2 Apr 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative colitis,
- Moderately active
- Stable medication
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Skåne
Malmö, Skåne County, 21428
Klas Sjöberg, Prof, +46702372580, klas.sjoberg@med.lu.se
Sanna Davidson, MD, +4640332185, sanna.davidson@med.lu.se
About this study
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.
Read the 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.
- Conditions
- Ulcerative Colitis, Diet Habit, Microbial Colonization
- Being tested
- Normal diet, E400 elimination
- Keywords
- Ulcerative colitis, Diet, Microbiota, Emulsifying agent
- Medical subject headings
- Colitis, Ulcerative, Feeding Behavior, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietOther
These patients will be given advice about a normal healthy diet.
E400 eliminationDietary supplement
Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | Other | One arm will be given dietary advice that is always given to patients with ulcerative colitis. Receives: 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. Receives: Dietary Supplement: E400 elimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin
A protein in faeces that increases when there is a flare of the colitis
Measured: One month
Microbiota diversity
The diversity of the GI microbiota reflects disease severity
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start2 Apr 2024
- Primary completion26 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized intervention study with elimination of putatively harmful substances in the diet
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klas Sjöberg, Region Skane
- Investigators
- Klas Sjöberg, Prof, Principal investigator, Dept of Gastroenterology, SUS, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743374
- Sponsor's protocol ID
- 2022-01347
- Acronym
- Mammoth
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be decided based upon cooperation status
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient and Additive Modifications May Optimize Diet To Health
- ClinicalTrials.gov ID
- NCT05743374
- Acronym / sponsor ID
- Mammoth / 2022-01347
- Conditions
- Ulcerative Colitis, Diet Habit, Microbial Colonization
- Keywords
- Ulcerative colitis, Diet, Microbiota, Emulsifying agent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 26 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized intervention study with elimination of putatively harmful substances in the diet
| Arm | Type | Receives |
|---|---|---|
| Normal diet | Other | Other: Normal dietOne arm will be given dietary advice that is always given to patients with ulcerative colitis. |
| E400 elimination | Active comparator | Dietary Supplement: E400 eliminationThe other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ulcerative colitis,
- Moderately active
- Stable medication
Key exclusion criteria (7 listed)
- Severe disease
- Recent surgery
- Proctitis
- Pregancy
- Treatment with antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dietThese patients will be given advice about a normal healthy diet. | Other | Normal diet |
| E400 eliminationPatients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates. | Dietary supplement | E400 elimination |
Primary outcome
Calprotectin
Time frame: One month
A protein in faeces that increases when there is a flare of the colitis
Microbiota diversity
Time frame: One month
The diversity of the GI microbiota reflects disease severity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. Will be decided based upon cooperation status
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klas Sjöberg, Prof principal investigator
Dept of Gastroenterology, SUS, Malmö, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet and E400 elimination in people with Ulcerative Colitis and Diet Habit, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klas Sjöberg, Prof (+46702372580, klas.sjoberg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calprotectin (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.