Clinical trial for Ulcerative Colitis (UC)
Official title Palmitoylethanolamide in Ulcerative Colitis
ClinicalTrials.gov ID: NCT07609810
What this study is testing
- What it's testing
- Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.
- Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and \< 12 at screening not responding to 5-aminosalicylates (5-ASA) defined as...
You likely can't join if
- Pregnancy or breastfeeding.
- Alcohol or drug abuse.
- Allergy or known hypersensitivity to palmitoylethanolamide.
- Active infection (enteric or systemic).
- Uncontrolled metabolic/ neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic...
- Other autoimmune diseases.
See the full eligibility criteria
- Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.
- Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and \< 12 at screening not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained...
- Pregnancy or breastfeeding.
- Alcohol or drug abuse.
- Allergy or known hypersensitivity to palmitoylethanolamide.
- Active infection (enteric or systemic).
- Uncontrolled metabolic/ neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic disease.
- Other autoimmune diseases.
- Severe or acute severe colitis requiring hospitalization.
- UC patients requiring colectomy.
- Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT).
- Patients with renal or liver disease.
- Patients who have never been treated for UC.
- Any patients on biologics.
- Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, El-Abbasia, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, El-Abbasia, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.