Clinical trial NCT05554445: Observational Investigation of the CDED in a Real World IBD Clinic
Official title: Observational Investigation of the CDED in a Real World IBD Clinic: Dietician and Patient Adaptations to the Dietary Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-09-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients who are prescribed the CDED during their routine clinical dietary therapy at the IBD clinic of the TLVMC.

Brief summary: A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. The diet is composed of three phases, at the end of the first two phases we will evaluate whether the patient achieved remission and at the end of phase three the maintenance of remission. We intend to study achievement and remission rate in association to the diet adaptations made by dieticians at phase 1 and 2, together with patient's choice off food at the third phase under real world clinical setting and patient lifestyle characteristics.

Detailed description: This is a prospective observational study that will follow a cohort of CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy at the IBD clinic of the TLVMC. The CD exclusion diet (CDED), is a whole-food diet designed to reduce exposure to dietary components, hypothesized to negatively affect the microbiome (dysbiosis), intestinal barrier, and intestinal immunity. We intend to follow patients with proven clinically active disease from the previous 4 months. Disease activity will be determined by Harvey-Bradshaw index (4\<HBI\<16) and Calprotectin\>50g.

The diet is composed of three phases, the first two included 5 mandatory foods consumed daily to provide specific fibers and starches as substrates for short chain fatty acids-producing taxa from Firmicutes, as well as sources of lean protein that were low in animal fat to decrease Proteobacteria and improve intestinal permeability, while maintaining a balanced diet. The diet included avoidance or reduction of exposure to foods containing animal/dairy fat, high fat from other sources, wheat, red or processed meat and protein sources rich in taurine, emulsifiers, artificial sweeteners, carrageenans and sulfites. The second phase stepdown diet involves higher exposure to fruits, vegetables, and legumes along with some foods that are reintroduced with restrictions to increase food flexibility and relieve monotony. The third phase of the study, is considered a maintenance phase in which patients are advised to continue practicing the concepts of the previous two phases, but they may generally manage their diet freely.

In this observational study, we aim to describe our real-world experience with the CDED, in a tertiary referral center for IBD patients. We aim to characterize both the adaptations of the first two phases of the diet practiced by IBD dieticians, and the food choices made by patients during the third phase of the diet . We aim to associate both these determinants with clinical remission at the end of phase two and remission maintenance at the end of phase three respectively.

Data collection

Upon visits, patients will be asked to fill in food frequency questionnaire (FFQ), 3-days recall questionnaires, food related quality of life, CD symptom and pain questionnaire. Dieticians will be asked to meticulously describe the adaptations they have performed in the CDED and the reasons for them at baseline, week 6 and 12. The adaptation will be made in accordance to patient's symptoms and disease characteristics.

At each visit, patient will provide a fecal sample which will be used to test for calprotectin, a biochemical marker, specific for intestine inflammation. Together with Harvey-Bradshaw index (HBI) we will determine disease severity and activity levels. Fecal sample will also use to determine and monitor changes in microbiome composition.

Anthropometric and nutritional evaluation

Patient's weight (kg), height (m), waist circumference (cm) will be documented at each study visit, and body mass index (BMI) will be calculated. Handgrip strength will be measured by a handgrip dynamometer (JAMAR® hydraulic hand dynamometer), and body composition by body electrical impedance (INBODY diagnostic weight).

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Clinically stable CD patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
3. Clinically active disease by CD symptoms score 4 \<Harvey-Bradshaw index (HBI) at baseline and Calprotectin\>50g/l / endoscopy / imaging proven active disease from the previous 4 months.

Exclusion Criteria:

1. Inability to sign informed consent and complete study protocol
2. Pregnancy

Primary outcomes:
measure: Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 1
timeFrame: week 6, end of phase 1
measure: Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 2
timeFrame: week 12, end of phase 2
measure: Rate of patients maintaining clinical remission at the end of phase 3
timeFrame: week 24, end of phase 3
Secondary outcomes:
measure: Associations between adaptations of the first phase of the diet practiced by IBD dieticians and clinical remission
timeFrame: week 6
measure: Associations between adaptations of the second phase of the diet practiced by IBD dieticians and clinical remission
timeFrame: week 12
measure: Associations between food choices during the third phase of the diet made by patients and remission maintenance
timeFrame: week 24
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Gastroentherology,Tel-Aviv Sourasky Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky medical center (Ichilov)
Study officials:
affiliation: Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center
name: Nitsan Maharshak, MD
role: PRINCIPAL_INVESTIGATOR
References: