Crohn's Disease
Conditions
Brief summary
Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will be tested in patients with inflammatory bowel disease.
Detailed description
Oral administration of Alequel prepared from patients biopsies will be tested in patients with inflammatory bowel disease to determine its anti inflammatory effect.
Interventions
DRUGAlequel
Alequel
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Crohn's disease
Exclusion criteria
* Immune suppression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Improved in Disease Activity | 15 weeks |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AlequelTM AlequelTM
Alequel: Alequel | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | AlequelTM |
|---|---|
| Age, Continuous | 35 years |
| Crohn's disease activity index | 303 units on a scale |
| Region of Enrollment Israel | 14 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Participants With Improved in Disease Activity
Time frame: 15 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AlequelTM | Number of Participants With Improved in Disease Activity | 0 participants |