Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743374
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-02-14
Brief Title:
Micronutrient and Additive Modifications May Optimize Diet To Health
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
Micronutrient and Additive Modifications May Optimize Diet To Health
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mammoth
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None