Ulcerative ColitisNCT06777706
Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patients with UC
A study testing QD (Qing Dai) in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- QD (Qing Dai)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jan 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Acute severe colitis (PUCAI>65).
- 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.
- Abnormal liver enzymes (ALT, AST, GGT) X2 times upper normal limit.
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Systemic steroid treatment at the time of enrollment (regardless of dose)
- Prior or current treatment with biologic therapy or JAK inhibitor.
Show all 10Show fewer
- Patient with active infection.
- Known immunodeficiency.
- Known allergy to QD.
- Pregnancy per questionnaire.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Shaare Zedek Medical Center - The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition
Jerusalem
Schneider Children's Medical Center
Petah Tikva
About this study
Official title: 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
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.
Read the detailed description
This is a prospective open-label pilot study in two Pediatric IBD centers at Schneider Children's Medical Center of Israel and Share Zedek Medical Center. Pediatric UC patients at both participating centers will be screened during clinic visits for eligibility to participate in the study. Eligible patients are 4-17.9 years old, with at least one month history of UC, with mild to moderate active UC, defined by a PUCAI score of 10-60, despite current treatment. Normal liver enzymes obtained within one most prior to initiation of the study is required. The study will be presented to the families and once it is established that the patient fulfills the inclusion criteria, informed written consent will be obtained from the patient and parents.
Enrollment:
At enrolment patients will be examined and explicit clinical, medical and demographic data will be documented. PUCAI16 and TUMMY-UC (patient reported outcome developed specifically for pediatric UC patients17) scores will be determined. Extent of disease will be documented according to the last available colonoscopy, using the Montreal classification definitions (additional endoscopic evaluation is not required for the study). Laboratory work including CBC, albumin, AST, ALT, ESR and CRP. A stool sample will be obtained and kept at -800C for future analyses (see below). In addition, a baseline echocardiography will be performed to assess for PAH prior to initiation of QD (see below). Patients of child bearing potential will be advised to safeguard against pregnancy.
Following completion of enrollment and initial testing patients will receive QD (see dosing regimens below). QD will be provided as oral capsules. Patients who are not able to swallow the capsules will be instructed to open then and give it with yogurt/soft food. Patients will be instructed to continue taking their maintenance medication as prescribed by their treating physician throughout the entire study period, without any changes.
Day 3-4:
Patients will be contacted via telephone and questioned regarding any adverse effects, and specifically headaches, along with colitis-associated clinical features.
Week 3:
Patients will be seen in clinic, and will also be examined, as part of routine clinical care. Clinical data will be obtained, including PUCAI and TUMMY-UC. Prior to this visit, patients will complete blood work including CBC, chemistry panel and CRP. A stool sample will be collected at this clinic visit.
Week 6:
Patients will be seen in clinic, and will also be examined, as part of routine clinical care. Clinical data will be obtained, including PUCAI and TUMMY-UC. Patients will also complete prior to this visit blood work including CBC, chemistry panel and CRP. An additional stool sample will be obtained and kept at -80 degrees celsius for future analyses. Finally, a repeated echocardiography will be completed. At this timepoint, the study will be completed.
Termination visit:
If the study will be terminated prior to completion of the 6 weeks of QD therapy (see criteria below) the patient will be seen in clinic for a "termination visit". In this visit clinical data will be obtained, including PUCAI and TUMMY-UC. Patients will also complete prior to this visit blood work including CBC, chemistry panel and CRP. An additional stool sample will be obtained and kept at -80 degrees celsius. for future analyses.
At each study visit, patients of child bearing potential will be asked if they are pregnant.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- QD (Qing Dai)
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QD (Qing Dai)Dietary supplement
Children age 4 years to 17.9 years with mild to moderate UC will receive QD and dosing will be stratified based on body weight at time of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving QD | Experimental | Patients will be receiving QD as oral capsules.
Dosing of QD will be stratified based on body weight at time of enrollment:
* 15-30kg: 500 mg/day (250 mg morning; 250 mg evening).
* 30-40kg: 750 mg/day (500 mg morning; 250 mg evening).
* >40kg: 1000mg/day (500 mg morning; 500 mg evening).
If the patient fails to respond by week 3 to current dosing regimens (failure defined as <20 decrease in PUCAI and PUCAI>10), and if no safety concerns arise at week 3, dose will be increased, as following:
* 15-30kg: 1000 mg/day (500 mg morning; 500 mg evening)
* 30-40kg: 1500 mg/day (1000 mg morning; 500 mg evening)
* >40kg: 2000mg/day (1000 mg morning; 1000 mg evening) Receives: Dietary Supplement: QD (Qing Dai) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission at 6 weeks
Rate of corticosteroid-free clinical remission at 6 weeks (defined as PUCAI<10) and a decrease in PUCAI score of at least 10.
Measured: Six weeks after the first dose of QD
Secondary outcomes (11)
Rate of clinical response
Rate of clinical response (PUCAI score decrease by 20 points or a decrease to less than 10) at week 6.
Measured: Six weeks after the first dose of QD
Calprotectin <250 mcg/g
Rate of calprotectin <250 mcg/g at week 6.
Measured: Six weeks after the first dose of QD
Calprotectin decrease - week 6
Rate of calprotectin decrease at week 6 by >50% compared to baseline level
Measured: Six weeks after the first dose of QD
Rate of clinical remission
Rate of clinical remission (PUCAI<10) at week 3.
Measured: Three weeks after the first dose of QD
Rate of clinical response
Rate of clinical response (PUCAI score decrease by 20 points or a decrease to less than 10) at week 3.
Measured: Three weeks after the first dose of QD
Calprotectin <100 mcg/g - week 6
Rate of calprotectin <100 mcg/g at week 6.
Measured: Six weeks after the first dose of QD
PUCAI<10 and calprotectin <100 mcg/g
Rate of PUCAI<10 and calprotectin <100 mcg/g at week 6.
Measured: Six weeks after the first dose of QD
Calprotectin decrease - week 3
Rate of calprotectin decrease at week 3 by >50% compared to baseline level.
Measured: Three weeks after the first dose of QD
Calprotectin <100 mcg/g - week 3
Rate of calprotectin <100 mcg/g at week 3.
Measured: Three weeks after the first dose of QD
PUCAI<10 and calprotectin <100 mcg/g - week 3
Rate of PUCAI<10 and calprotectin <100 mcg/g at week 3.
Measured: Three weeks after the first dose of QD
Rate of QD-associated adverse events
Rate of QD-associated adverse events including but not limited to: PAH, elevation in liver enzymes, headaches.
Measured: Six weeks after the first dose of QD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dotan Yogev, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777706
- Sponsor's protocol ID
- QD
- Status last verified
- Jan 2025
- First submitted
- 4 May 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06777706
- Acronym / sponsor ID
- QD
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective open-label pilot study in two Pediatric IBD centers at Schneider Children's Medical Center of Israel and Share Zedek Medical Center. Pediatric UC patients at both participating centers will be screened during clinic visits for eligibility to participate in the study. Eligible patients are 4-17.9 years old, with at least one month history of UC, with mild to moderate active UC, defined by a PUCAI score of 10-60, despite current treatment. Normal liver enzymes obtained within one most prior to initiation of the study is required. The study will be presented to the families and once it is established that the patient fulfills the inclusion criteria, informed written consent will be obtained from the patient and parents.
Enrollment:
At enrolment patients will be examined and explicit clinical, medical and demographic data will be documented. PUCAI16 and TUMMY-UC (patient reported outcome developed specifically for pediatric UC patients17) scores will be determined. Extent of disease will be documented according to the last available colonoscopy, using the Montreal classification definitions (additional endoscopic evaluation is not required for the study). Laboratory work including CBC, albumin, AST, ALT, ESR and CRP. A stool sample will be obtained and kept at -800C for future analyses (see below). In addition, a baseline echocardiography will be performed to assess for PAH prior to initiation of QD (see below). Patients of child bearing potential will be advised to safeguard against pregnancy.
Following completion of enrollment and initial testing patients will receive QD (see dosing regimens below). QD will be provided as oral capsules. Patients who are not able to swallow the capsules will be instructed to open then and give it with yogurt/soft food. Patients will be instructed to continue taking their maintenance medication as prescribed by their treating physician throughout the entire study period, without any changes.
Day 3-4:
Patients will be contacted via telephone and questioned regarding any adverse effects, and specifically headaches, along with colitis-associated clinical features.
Week 3:
Patients will be seen in clinic, and will also be examined, as part of routine clinical care. Clinical data will be obtained, including PUCAI and TUMMY-UC. Prior to this visit, patients will complete blood work including CBC, chemistry panel and CRP. A stool sample will be collected at this clinic visit.
Week 6:
Patients will be seen in clinic, and will also be examined, as part of routine clinical care. Clinical data will be obtained, including PUCAI and TUMMY-UC. Patients will also complete prior to this visit blood work including CBC, chemistry panel and CRP. An additional stool sample will be obtained and kept at -80 degrees celsius for future analyses. Finally, a repeated echocardiography will be completed. At this timepoint, the study will be completed.
Termination visit:
If the study will be terminated prior to completion of the 6 weeks of QD therapy (see criteria below) the patient will be seen in clinic for a "termination visit". In this visit clinical data will be obtained, including PUCAI and TUMMY-UC. Patients will also complete prior to this visit blood work including CBC, chemistry panel and CRP. An additional stool sample will be obtained and kept at -80 degrees celsius. for future analyses.
At each study visit, patients of child bearing potential will be asked if they are pregnant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving QD | Experimental | Dietary Supplement: QD (Qing Dai)Patients will be receiving QD as oral capsules. Dosing of QD will be stratified based on body weight at time of enrollment: * 15-30kg: 500 mg/day (250 mg morning; 250 mg evening). * 30-40kg: 750 mg/day (500 mg morning; 250 mg evening). * >40kg: 1000mg/day (500 mg morning; 500 mg evening). If the patient fails to respond by week 3 to current dosing regimens (failure defined as <20 decrease in PUCAI and PUCAI>10), and if no safety concerns arise at week 3, dose will be increased, as following: * 15-30kg: 1000 mg/day (500 mg morning; 500 mg evening) * 30-40kg: 1500 mg/day (1000 mg morning; 500 mg evening) * >40kg: 2000mg/day (1000 mg morning; 1000 mg evening) |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- Acute severe colitis (PUCAI>65).
- 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.
- Abnormal liver enzymes (ALT, AST, GGT) X2 times upper normal limit.
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Systemic steroid treatment at the time of enrollment (regardless of dose)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QD (Qing Dai)Children age 4 years to 17.9 years with mild to moderate UC will receive QD and dosing will be stratified based on body weight at time of enrollment. | Dietary supplement | Patients receiving QD |
Primary outcome
Clinical remission at 6 weeks
Time frame: Six weeks after the first dose of QD
Rate of corticosteroid-free clinical remission at 6 weeks (defined as PUCAI<10) and a decrease in PUCAI score of at least 10.
11 secondary outcomes
Rate of clinical response
Time frame: Six weeks after the first dose of QD
Calprotectin <250 mcg/g
Time frame: Six weeks after the first dose of QD
Calprotectin decrease - week 6
Time frame: Six weeks after the first dose of QD
Rate of clinical remission
Time frame: Three weeks after the first dose of QD
Rate of clinical response
Time frame: Three weeks after the first dose of QD
Calprotectin <100 mcg/g - week 6
Time frame: Six weeks after the first dose of QD
PUCAI<10 and calprotectin <100 mcg/g
Time frame: Six weeks after the first dose of QD
Calprotectin decrease - week 3
Time frame: Three weeks after the first dose of QD
Calprotectin <100 mcg/g - week 3
Time frame: Three weeks after the first dose of QD
PUCAI<10 and calprotectin <100 mcg/g - week 3
Time frame: Three weeks after the first dose of QD
Rate of QD-associated adverse events
Time frame: Six weeks after the first dose of QD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dotan Yogev, MD principal investigator
Shaare Zedek Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QD (Qing Dai) in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Shaare Zedek Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission at 6 weeks (time frame: Six weeks after the first dose of QD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.