Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343642
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2006-06-21
Brief Title:
Dietary Treatment of Crohns Disease
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Dietary Treatment of Crohns Disease
Status:
COMPLETED
Status Verified Date:
2021-05
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:
None
Brief Summary:
Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide FOS supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohns Disease CD
Detailed Description:
Several epidemiological studies and therapeutic observations in the complementary and alternative medicine CAM literature suggest that diet is key to development of CD and its treatment The investigators took advantage of these CAM recommendations and designed dietary interventions Our preliminary open label studies in IBD patients showed that our interventions are acceptable and well-tolerated and result in improvement reducing symptoms andor the degree of inflammation The investigators are now seeking to validate this finding and determine the mechanisms underlying the effects of dietary manipulation-such as potential effects on colonic bacterial microflora In another pilot study using 16s rDNA bacterial fingerprinting the investigators demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals Whether the investigators can normalizechange the microflora of CD patients with dietary therapies however remains to be determined Accordingly the investigators designed a double blind placebo controlled study to test the hypotheses that 1 dietary manipulation with either diet or a FOS supplement is an effective CAM therapy that prevents CD relapse leads to maintenance of remission and 2 such dietary manipulation can normalize the microflora of CD patients and decrease mucosal oxidative damage
90 participants are expected to undergo the trial and have a 21 chance of receiving active therapy The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment Participants must be on their Crohns medications at a stable dose for 3 months which does not include steroids eg Prednisone Entocort or antibiotics at the time of enrollment Participants will be followed till relapse occurs or up to 52 weeks Participants are asked to fill out a variety of questionnaires keep a food and adverse event diary and have a research limited unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period
Significance This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive randomized controlled trials
90 participants are expected to undergo the trial and have a 21 chance of receiving active therapy The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment Participants must be on their Crohns medications at a stable dose for 3 months which does not include steroids eg Prednisone Entocort or antibiotics at the time of enrollment Participants will be followed till relapse occurs or up to 52 weeks Participants are asked to fill out a variety of questionnaires keep a food and adverse event diary and have a research limited unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period
Significance This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive randomized controlled trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT001628-01A2 | NIH | None | httpsreporternihgovquickSearchR21AT001628-01A2 |