Back to resultsMicronutrient and Additive Modifications May Optimize Diet To Health (Mammoth)
Primary Purpose
Ulcerative Colitis, Diet Habit, Microbial Colonization
Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Normal diet
E400 elimination
Sponsored by
About this trial
This is an interventional other trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Diet, Microbiota, Emulsifying agent
Eligibility Criteria
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
Sites / Locations
- Region Skåne
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Normal diet
E400 elimination
Arm Description
One arm will be given dietary advice that is always given to patients with ulcerative colitis.
The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.
Outcomes
Primary Outcome Measures
Calprotectin
A protein in faeces that increases when there is a flare of the colitis
Microbiota diversity
The diversity of the GI microbiota reflects disease severity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05743374
Brief Title
Micronutrient and Additive Modifications May Optimize Diet To Health
Acronym
Mammoth
Official Title
Micronutrient and Additive Modifications May Optimize Diet To Health
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Diet Habit, Microbial Colonization
Keywords
Ulcerative colitis, Diet, Microbiota, Emulsifying agent
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized intervention study with elimination of putatively harmful substances in the diet
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal diet
Arm Type
Other
Arm Description
One arm will be given dietary advice that is always given to patients with ulcerative colitis.
Arm Title
E400 elimination
Arm Type
Active Comparator
Arm Description
The other arm will be given advice to eliminate E400 substances with special regard to carragenan, CMC and polysorbates.
Intervention Type
Other
Intervention Name(s)
Normal diet
Intervention Description
These patients will be given advice about a normal healthy diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
E400 elimination
Intervention Description
Patients in the intervention group will be given advice how to eliminate E440 additives with regard to carragenan, CMC and polysorbates.
Primary Outcome Measure Information:
Title
Calprotectin
Description
A protein in faeces that increases when there is a flare of the colitis
Time Frame
One month
Title
Microbiota diversity
Description
The diversity of the GI microbiota reflects disease severity
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klas Sjöberg, Prof
Phone
+46702372580
Email
klas.sjoberg@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sanna Davidson, MD
Phone
+4640332185
Email
sanna.davidson@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klas Sjöberg, Prof
Organizational Affiliation
Dept of Gastroenterology, SUS, Malmö, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Skåne
City
Malmö
State/Province
Skåne
ZIP/Postal Code
21428
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klas Sjöberg, Prof
Phone
+46702372580
Email
klas.sjoberg@med.lu.se
First Name & Middle Initial & Last Name & Degree
Sanna Davidson, MD
Phone
+4640332185
Email
sanna.davidson@med.lu.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will be decided based upon cooperation status
Learn more about this trial
Micronutrient and Additive Modifications May Optimize Diet To Health
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