Crohn's Disease Clinical Trial
Official title:
Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.
Patients will be seen in clinic at new diagnosis of Crohn's disease or a flare of existing
disease. Potential subjects will be screened with for eligibility, followed by a baseline
assessment by the clinic provider. Subjects who wish to participate will undergo further
discussion with one of the study staff. At enrollment, a member of the study staff will
explain the study to the prospective participant (for consent and/or assent, if applicable
given patient's age).
The SCD will be started in addition to previous maintenance medication therapy or with short
course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). Steroid induction based on
clinical need.
We anticipate improvement in clinical symptoms, laboratory values and/or a decline in PCDAI
of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients) after 4
weeks. Patients who do not reach remission by 4 weeks will be excluded from the study.
Patients who require additional medications for disease control will be excluded from the
study.
Patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1
month, 3 months and 6 months.
Assessment at initial enrollment and at all follow-up visits includes:
1. History of symptoms
2. Physical exam including height, weight, BMI, Tanner staging
3. Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients
or the Crohn's Disease Activity Index (CDAI) score for adult patients.
4. Dietary assessment and nutritional counseling
5. Completion of validated quality of life measurement (IMPACT III for pediatric patients
and SIBDQ in adult patients)
6. Adverse event monitoring (record of symptoms and review of laboratory surveillance)
7. Laboratory assessment including: CBC with differential, basic metabolic panel, liver
function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
8. Serum sample for cytokine studies
9. Stool studies for microbiota studies
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
Completed |
NCT01951326 -
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
|
Phase 3 |