NCT06777706Completed
Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patients with UC
An Open-label Study to Assess the Safety and Efficacy of QD (Indigo Naturalis) Food Supplement for Induction of Remission in Pediatric Patients with Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 16 Jan 2025
Brief summary (registry, in English)
To date, there are no reports on the use of QD in pediatric patients with UC. There is a great need to increase the repertoire of anti-inflammatory interventions for remission induction, especially in children given the notorious side effects of steroids on growth. Importantly, no prescription is needed to acquire QD, as this is a food supplement that can be purchased over the counter. We wish to assess the efficacy and safety of QD as induction therapy in pediatric patients with mild-moderate active UC.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 4 May 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Sept 2024
- Lead sponsor
- Shaare Zedek Medical Center
- Diseases
- Ulcerative colitis
- NCT number
- NCT06777706
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 1 Jan 2023 to the primary completion date, 1 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic steroid treatment at the time of enrollment (regardless of dose)
- Prior or current treatment with biologic therapy or JAK inhibitor.
Other illness
- Patient with chronic renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, previous malignancy, uncontrolled migraines or neurological disorders.
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Patient with active infection.
- Known allergy to QD.
Lab values
- Abnormal liver enzymes (ALT, AST, GGT) X2 times upper normal limit.
Other
- Acute severe colitis (PUCAI\>65).
- Known immunodeficiency.
- Pregnancy per questionnaire.
Who the study is looking for
- Established diagnosis of UC for at least one month based on accepted criteria15.
- Age 4-17.9 years old (inclusive).
- Weight ≥ 15kg
- PUCAI 10-60 at enrollment (reflecting mild-moderate UC).
- If a patient is receiving oral 5-ASA, the dose must be stable for at least 4 weeks prior to inclusion.
- If patient is receiving immunomodulator medication (azathioprine or 6- mercaptopurine), dose must be stable for at least 3 months prior to inclusion.
- If a patient is on topical 5-ASA (suppositories or enema) the dose must be stable for at least 2 weeks prior to inclusion and will not be altered throughout the 6-week study period.
- Negative stool culture, parasites and clostridium difficile testing.
Age in the registry: 4 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Medical Center - The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.