Gastroenterology · 2026
Proactive Fecal Calprotectin Home Monitoring in Ulcerative Colitis: Results of a Prospective Randomized Controlled Trial.
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Rosenfeld Gregory, Narula Neeraj, Leung Yvette, Afif Waqqas, Williams Astrid-Jane, Huang Vivian, Singh Harminder, McCurdy Jeffrey D, Jairath Vipul, Lam Mindy, Loomes Dustin E, Zezos Petros, Stewart Michael, Ma Christopher, Ropeleski Mark, Ancheta-Schmit Maria, Tavakoli Pedram, Bone Jeffrey N, Lewis James D, Colombel Jean-Frederic, Bressler Brian
Аннотация
BACKGROUND & AIMS: Elevated fecal calprotectin (FC), a biomarker of intestinal inflammation, can be detected 3 months before symptomatic flare in patients with ulcerative colitis (UC). We hypothesized that proactive home-based FC monitoring would prevent symptomatic flares in patients with UC in remission.
METHODS: This prospective, multicenter clinical trial randomized adults with a modified partial Mayo score ≤2 and no rectal bleeding to standard care or FC testing every 2 months for 18 months or until symptomatic flare. Confirmatory FC testing was performed within 2 weeks for FC ≥250 μg/g; change in therapy was at physician discretion. Primary end point was time to symptomatic flare. Secondary end points included health care use, medication use, and quality of life.
RESULTS: The trial enrolled 716 patients; 308 in the control arm and 303 in the intervention arm were analyzed. Mean age was 42 years, and 47% were men. Distribution of disease extent was similar in both arms, and 45% were on advanced therapy. Symptomatic flare occurred in 32% in both arms; median time to flare was not reached. There was no difference in risk for symptomatic flare overall (hazard ratio, 1.05; 95% confidence interval, 0.79-1.40), by disease extent, or advanced therapy use. Flare frequency was lower among the 88 who changed therapy after confirmatory elevated FC (49% vs 55%), but flare risk was not different. There were no differences in secondary end points.
CONCLUSIONS: Our results suggest that proactive home-based FC monitoring without protocolized escalation does not prevent symptomatic flares. Additional studies are needed to define the optimal use of FC monitoring and the benefit of early intervention.
CLINICALTRIALS: gov number: NCT03549988.
METHODS: This prospective, multicenter clinical trial randomized adults with a modified partial Mayo score ≤2 and no rectal bleeding to standard care or FC testing every 2 months for 18 months or until symptomatic flare. Confirmatory FC testing was performed within 2 weeks for FC ≥250 μg/g; change in therapy was at physician discretion. Primary end point was time to symptomatic flare. Secondary end points included health care use, medication use, and quality of life.
RESULTS: The trial enrolled 716 patients; 308 in the control arm and 303 in the intervention arm were analyzed. Mean age was 42 years, and 47% were men. Distribution of disease extent was similar in both arms, and 45% were on advanced therapy. Symptomatic flare occurred in 32% in both arms; median time to flare was not reached. There was no difference in risk for symptomatic flare overall (hazard ratio, 1.05; 95% confidence interval, 0.79-1.40), by disease extent, or advanced therapy use. Flare frequency was lower among the 88 who changed therapy after confirmatory elevated FC (49% vs 55%), but flare risk was not different. There were no differences in secondary end points.
CONCLUSIONS: Our results suggest that proactive home-based FC monitoring without protocolized escalation does not prevent symptomatic flares. Additional studies are needed to define the optimal use of FC monitoring and the benefit of early intervention.
CLINICALTRIALS: gov number: NCT03549988.