Crohn Disease Clinical Trial
Official title:
Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom control and disease remission. Historically certain diets have been recommended for patients with Crohn's disease during exacerbations despite lack of data supporting efficacy. The investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to moderately active Crohn's disease to one of two diets that differ in the amount and type of carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the microbiome.
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be
beneficial for Crohn's disease for a period of 8 weeks.
Initial evaluation will include a clinic visit with physical exam, medication review,
supplemental documentation, and labs. Patients will be asked about their food allergies and
intolerances against a master list of all ingredients used in both diets. Patients will then
be provided with instructions on how to record their baseline dietary intake for two weeks
prior to the intervention diet.
At day 0 patients will begin their study diet. All study meals will be provided to the
subject and an approved snack list for the randomized diet will be provided in a sealed
envelope with their first week of meals.
At the conclusion of intervention patients will be asked to resume their previous diet for 4
weeks and record their dietary intake. Stool and blood will be collected at baseline and at
4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were
on and will be provided with dietary consultation by a registered dietitian.
Subjects who withdraw from the study before the 4 week assessment will be asked to provide a
final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week
4, subject replacement will occur.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 | |
Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 |