3 Key Takeaways
Plain English Summary- 01Core Finding
Treatment effect on the primary outcome, FC response, was analyzed using generalized estimating equations for the two-period, two-sequence crossover design, following the intention-to-treat principle.
- 02Study Evidence
Tested in a randomized controlled trial (n=14) at the randomized clinical trial stage.
- 03Practical Meaning
Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.
What This Means for You
These findings demonstrate the modifiability of low-grade intestinal inflammation in healthy high-risk FDRs with persistent FC elevation but without diagnostic endoscopic evidence of CD, supporting long-term dietary prevention trials (ClinicalTrials.gov #NCT05211518).
The Discovery
With the rising prevalence of inflammatory bowel disease (IBD), preventing new-onset disease becomes a priority. The PIONIR (Preventing IBD ONset in Individuals at Risk) randomized controlled trial explored whether the Tasty&Healthy (T&H) diet reduces inflammatory markers in high-risk first-degree relatives (FDRs) of patients with Crohn's disease (CD). FDRs with persistently elevated fecal calprotectin (FC, >70μg/g) and, at most, nonspecific mucosal abnormalities (edema or ≤10 aphthous ulcers) on video-capsule endoscopy or ileocolonoscopy were randomized to T&H or habitual diet (HD) for 8 weeks, followed by crossover for additional 8 weeks. Treatment effect on the primary outcome, FC response, was analyzed using generalized estimating equations for the two-period, two-sequence crossover design, following the intention-to-treat principle. Twenty-nine FDRs were randomized (n=14 T&H-first, n=15 HD-first). At week 8, median FC was lower with T&H (64μg/g [IQR 44-127]) vs. HD (112μg/g [74-227]; P=.022). FC decreased by ≥a clinically meaningful level in 71% on T&H versus 27% on HD (RR=2.68 [95%CI 1.09-6.60]; P=.016). Across both crossover periods, estimated marginal mean FC declined from 185μg/g [95%CI 144-237] by 61% to 72μg/g [95%CI 57-91] with T&H, versus 38% to 114μg/g [95%CI 93-140] with HD (ratio 0.63 [95%CI 0.51-0.80], translating to 37% overall decrease with T&H; P<0.001). Six microbial species differed between diets after FDR correction. By week 8, 79% rated T&H acceptable and 83% had good or complete adherence.
How It Works, Simply
This gastroenterology research focuses on inflammation. Researchers evaluated it using a randomized controlled trial (n=14) at the randomized clinical trial stage of medical research.
3 Key Takeaways
Clinical Takeaways- 01Core Finding
Treatment effect on the primary outcome, FC response, was analyzed using generalized estimating equations for the two-period, two-sequence crossover design, following the intention-to-treat principle.
- 02Study Evidence
Tested in a randomized controlled trial (n=14) at the randomized clinical trial stage.
- 03Practical Meaning
Controlled trial findings show causal benefit under protocol rules; real-world effectiveness can vary across patients.
Key Numbers
Biological Mechanism & Study Design
Study Design & Cohort
Randomized controlled trial
Randomized controlled trial (n=14) · Randomized Clinical Trial
Biological Pathway & Modality
Inflammation
Intervention: TASTY AND HEALTHY DIET
Experimental Findings & Endpoints
With the rising prevalence of inflammatory bowel disease (IBD), preventing new-onset disease becomes a priority.
The PIONIR (Preventing IBD ONset in Individuals at Risk) randomized controlled trial explored whether the Tasty&Healthy (T&H) diet reduces inflammatory markers in high-risk first-degree relatives (FDRs) of patients with Crohn's disease (CD). FDRs with persistently elevated fecal calprotectin (FC, >70μg/g) and, at most, nonspecific mucosal abnormalities (edema or ≤10 aphthous ulcers) on video-capsule endoscopy or ileocolonoscopy were randomized to T&H or habitual diet (HD) for 8 weeks, followed by crossover for additional 8 weeks.
Treatment effect on the primary outcome, FC response, was analyzed using generalized estimating equations for the two-period, two-sequence crossover design, following the intention-to-treat principle. Twenty-nine FDRs were randomized (n=14 T&H-first, n=15 HD-first).
At week 8, median FC was lower with T&H (64μg/g [IQR 44-127]) vs. HD (112μg/g [74-227]; P=.022).
FC decreased by ≥a clinically meaningful level in 71% on T&H versus 27% on HD (RR=2.68 [95%CI 1.09-6.60]; P=.016). Across both crossover periods, estimated marginal mean FC declined from 185μg/g [95%CI 144-237] by 61% to 72μg/g [95%CI 57-91] with T&H, versus 38% to 114μg/g [95%CI 93-140] with HD (ratio 0.63 [95%CI 0.51-0.80], translating to 37% overall decrease with T&H; P<0.001).
Six microbial species differed between diets after FDR correction. By week 8, 79% rated T&H acceptable and 83% had good or complete adherence.
Clinical Translation & Practice Context
These findings demonstrate the modifiability of low-grade intestinal inflammation in healthy high-risk FDRs with persistent FC elevation but without diagnostic endoscopic evidence of CD, supporting long-term dietary prevention trials (ClinicalTrials.gov #NCT05211518).
The Bottom Line · Clinical Pearl
“These findings demonstrate the modifiability of low-grade intestinal inflammation in healthy high-risk FDRs with persistent FC elevation but without diagnostic endoscopic evidence of CD, supporting long-term dietary prevention trials (ClinicalTrials.gov #NCT05211518).”
Published in Gastroenterology · Current Stage: Randomized Clinical Trial
