Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorUniversity of British Columbia
About this trial
Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Moderate-severe active luminal inflammatory (B1) pCD [wPCDAI > or = 40] ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +/- colonic (L1, L2, L3), and in whom treating physician plans to start IFX
Within 12-months of diagnosis (when starting IFX treatment)
Naïve to a biologic therapy
Disqualifiers
CDED, EEN, or steroids commenced more than 2 weeks prior to randomization
Antibiotic use in the last 2 months (except short course < 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)
Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)
Strict vegetarians and vegans
Trial design
Design model
Parallel
Treatments tested in this trial
IFX + mCDED
Other interventionmodified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: IFX + mCDEDExperimental treatment 1 intervention
Group B: IFXNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Clinical and biochemical response at the first infliximab (IFX) maintenance dose (week 12) in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.
Clinical response: defined as mild or inactive clinical disease (at least a 17.5-points decrease in weighted paediatric Crohn's disease activity index (wPCDAI) from baseline, with a score \< 40), physician global assessment (PGA) of inactive or mild disease activity, off steroids, continuation on the same anti-TNFα dose, and remaining surgery-free. Biochemical response: Defined as at least a 50% decrease in fecal calprotectin (FCP) levels compared to baseline. wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity. PGA ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame
12 weeksSecondary outcomes
1
Steroid-free clinical and biochemical remission at week 12 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.
Steroid-free clinical remission (SFCR): defined as an inactive disease (wPCDAI \<12.5), PGA of inactive disease, no steroid use in the preceding 28 days, continuation on IFX and remaining surgery-free. Biochemical remission: defined as a normalization of C-reactive protein (CRP) (\< 5 mg/L) and Erythrocyte Sedimentation Rate (ESR) (\< 15-20 mm/h, male \& female respectively) if available, and FCP level \< 250 µg/g. wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity. PGA ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame
12 weeks2
Steroid-free clinical and biochemical response at weeks 24 and 52 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.
Steroid-free clinical response: defined as mild or inactive clinical disease (at least a 17.5-points decrease in weighted paediatric Crohn's disease activity index (wPCDAI) from baseline, with a score \< 40), physician global assessment (PGA) of inactive or mild disease activity, off steroids, continuation on the same anti-TNFα dose, and remaining surgery-free. Biochemical response: Defined as at least a 50% decrease in fecal calprotectin (FCP) levels compared to baseline. wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity. PGA ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame
24 and 52 weeks3
Proportion of participants achieving steroid-free clinical and biochemical remission at weeks 24 and 52 in participants receiving mCDED alongside IFX compared with participants receiving IFX alone.
Steroid-free clinical remission (SFCR): defined as an inactive disease (wPCDAI \<12.5), PGA of inactive disease, no steroid use in the preceding 28 days, continuation on IFX and remaining surgery-free. Biochemical remission: defined as a normalization of C-reactive protein (CRP) (\< 5 mg/L) and Erythrocyte Sedimentation Rate (ESR) (\< 15-20 mm/h, male \& female respectively) if available, and FCP level \< 250 µg/g. wPCDAI ranges from 0 to 125, with higher scores indicating greater disease activity. PGA ranges from 0 to 10, with higher scores indicating greater disease activity.
Time frame
weeks 24 and 524
1-year composite score of clinical remission and biochemical remission in addition to meeting criteria for steroid-free clinical remission adjusted for week 12 IFX trough level.
1-year composite score remission: defined as the concurrent achievement of clinical remission and biochemical remission at the 12-month follow-up. This score will be adjusted by the IFX blood level (in µg/mL) measured at week 12. Steroid-free clinical remission (SFCR): defined as an inactive disease (wPCDAI \<12.5), PGA of inactive disease, no steroid use in the preceding 28 days, continuation on IFX and remaining surgery-free. Biochemical remission: defined as a normalization of C-reactive protein (CRP) (\< 5 mg/L) and Erythrocyte Sedimentation Rate (ESR) (\< 15-20 mm/h) if available, and FCP level \< 250 µg/g. 1-year composite score: 0 = no remission 1. = clinical or biochemical remission 2. = clinical and biochemical remission
Time frame
Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov