Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patients with UC

NCT06777706 | Completed

• 1 other identifier: QD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Six weeks after the first dose of QD

Secondary Outcomes (11)

• Rate of clinical response

  Six weeks after the first dose of QD

• Calprotectin <250 mcg/g

  Six weeks after the first dose of QD

• Calprotectin decrease - week 6

  Six weeks after the first dose of QD

• Rate of clinical remission

  Three weeks after the first dose of QD

• Rate of clinical response

  Three weeks after the first dose of QD

Study Arms (1)

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)

Dietary Supplement: QD (Qing Dai)

Interventions

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.

Patients receiving QD

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• Negative stool culture, parasites and clostridium difficile testing.

You may not qualify if:

• 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.
• Patient with active infection.
• Known immunodeficiency.
• Known allergy to QD.
• Pregnancy per questionnaire.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (2)

Shaare Zedek Medical Center - The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition

Jerusalem, Israel

Location

Schneider Children's Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Qingdai compound

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Dotan Yogev, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: January 16, 2025
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

IL (2)