Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Asian Institute of Gastroenterology | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The rising incidence of Crohn's disease (CD) and ulcerative colitis (UC), especially in the newly industrialized nations of Asia, highlights the possible role of environmental triggers such as diet and the gut microbiome in the pathogenesis of inflammatory bowel diseases (IBD). The Mediterranean diet (MED) has been previously correlated with beneficial outcomes in several chronic and immune-mediated diseases and has been linked with positive outcomes in IBD. However, consumption of high fiber foods like fruits, vegetables, whole grains, legumes and nuts may be challenging for patients with IBD without tight dietary guidance and support.
The IBDMED nutritional education program aims to improve the adherence of patients with IBD to MED. Patients are educated on how to implement and incorporate MED principles into their daily lifestyle, by providing information, tips, practical tools, cooking methods and recipes, that are available on an interactive website and application. Patients are monitored for their diet, sleep, physical activity and stress levels via fitness trackers and questionnaires developed for this study and receive feedback and personal recommendations from the study dietitians along the way.
This RCT will assess the feasibility and effects of an 8-week IBDMED nutritional and lifestyle education program vs. the nutritional standard of care in patients with newly diagnosed CD and in healthy subjects in Israel and India.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBDMED-ISR | Other | Patients with newly diagnosed CD in Israel |
|
| IBDMED-IND | Other | Patients with newly diagnosed CD in India |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBDMED | Other | The IBDMED program will be applied for 8 weeks and include education on MED diet and lifestyle components, focused on increasing and diversifying dietary fiber intake, reduction of ultra-processed food intake and promoting an active lifestyle. This intervention is digitally supported by an interactive website application and step trackers to monitor lifestyle parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite biological score | A composite biological score comprised of changes in clinical (HBI/CDAI), inflammatory (CRP/calprotectin) and microbial (diversity, MDI) indices. A decrease in clinical indices, inflammatory markers or MDI will be considered positive and will be scored as follows: -10%: +1 point, -20%: +2 points, -30%: +3 points; An increase in microbial diversity will be considered positive and will be scored as follows: +10%: +1 point, +20%: +2 points, +30%: +3 points. The composite biological score ranges between 0-15 points. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and inflammatory response | Decrease in inflammatory activity: at least 30% decrease in HBI and/or CDAI and the additional inflammatory biomarker used at inclusion. In any case where CRP or fecal calprotectin were elevated, they will be used to evaluate decreased activity. | 8 weeks |
| Improvement in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial outcomes- alpha diversity | Microbial diversity will be compared between groups and intra-individual changes will be assessed using paired analysis. | 8 weeks |
| Microbial outcomes- Microbial dysbiosis index |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Dotan, Prof | Contact | +97237525015 | irisdo@clalit.org.il | |
| Lihi Godny, PhD | Contact | +97237525015 | lihigodny@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology | Recruiting | Hyderabad | India |
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Other | Dietary counseling according to the local dietary guidelines for patients with IBD |
|
Improved quality of life as assessed by the PRO2 (≥50% or ≥ 4 points) |
| 8 weeks |
| Dietary adherance | Adherence to IBDMED in India and Israel-measured by IBDMED score. The IBDMED adherance screener includes 11 items and ranges between 0-30. | 8 weeks |
MDI will be compared between groups and intra-individual changes will be assessed using paired analysis.
| 8 weeks |
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
|