Successful Integration of IBDoc® Fecal Calprotectin Home Test into an HL7 Hospital Remote Monitoring System: Flarometer

An interview with Prof. Dr. Patrick van Rheenen, University Medical Center Groningen, The Netherlands

Prof. Dr. Patrick van Rheenen, University Medical Center Groningen
Fecal calprotectin levels in pediatric cow's milk protein allergy

The most prevalent food allergy in younger children is cow’s milk protein allergy (CMPA), and its most common clinical manifestation is allergic colitis. This study shows a significant decrease in FC levels and clinical symptoms when a strict elimination diet is adopted. Measuring FC levels to monitor the extent of intestinal inflammation caused by the allergen is proposed

Lendvai-Emmert et al. (2022) Frontiers in Pediatrics
Mistakes in paediatric inflammatory bowel disease and how to avoid them

Around 1 in 10 cases of inflammatory bowel disease (IBD) will present before adulthood, with the median age at presentation being 11–12 years.1 IBD in children and young people is associated with more extensive disease, increased disease activity and a higher rate of complications compared with adult-onset IBD.2Worldwide, estimates of paediatric IBD prevalence rates are lacking, but data suggest its incidence is increasing.3

United European Gastroenterology Education 
Paediatric reference ranges for faecal calprotectin: a UK study

In our local population, faecal calprotectin varies with age. Children aged 1–3.9 years had higher concentrations of faecal calprotectin than adults, but there was no significant difference in faecal calprotectin between older children and adults.

Davidson, et al. (2017) Annals of Clinical Biochemistry
Relationship between fecal calprotectin and upper endoscopy findings in children with upper gastrointestinal symptoms

There was a statistically significant correlation between fecal calprotectin and gastritis and severity of H. pylori infection. Fecal calprotectin level measurement can avoid unnecessary endoscopies and is also useful for evaluation of therapy response.

Ataee et al. (2017) Iranian Journal of Pediatrics in Press
Diagnostic Value of Fecal Calprotectin Point of Care Testing in the Paediatric Practice

There was a strong correlation between the results obtained from the point of care test and the ELISA assay. FC point of care testing is a useful non-invasive screening tool in paediatric practice.

Shentova, et al. (2016) Merit Research Journal of Medicine and Medical Sciences
Comparison of three tests for faecal calprotectin in children and young adults: a retrospecitve monocentric study

All three tests are very sensitive for detecting mucosal inflammation, but major differences exist between specificity and absolute values. It is highly advisable to use the test of the same manufacturer for follow-up and to monitor for disease activity.

Prell, et al. (2014). British Medical Journal
Faecal Calprotectin in healthy children

As a result, three cut-off levels were established based on the 97.5% percentiles of FC in different age groups: 538 mg/kg (1 < 6 months), 214 mg/kg (6 months < 3 years) and 75 mg/kg (3 < 4 years).

Oord, et al. (2014) Scandinavian Journal of Gastroenterology
Elevated Faecal Calprotectin in Children with Colonic Juvenile Polyps

Elevated levels of faecal calprotectin may indicate juvenile polyps in children. Examination with colonoscopy is still warranted in the pediatric population with elevated levels of faecal calprotectin.

Toth et al. (2009) UEGW/WCOG London, poster presentation
Measurement of calprotectin in faeces

Correct use of the test can therefore contribute to reducing the number of unnecessary colonoscopies, which is especially important in children.

 Jahnsen et al. (2008) The Journal of Norwegian Medical Association
Age dependent variations in fecal calprotectin concentrations in children

No accumulation of calprotectin-rich leukocytes occurs in the healthy intestinal mucosa in the first months of life or later; therefore, the high calprotectin concentrations found, especially in some of the children in the youngest age groups, may reflect increased migration of neutrophil granulocytes into the gut lumen in early life.

 Rugtveit, et al. (2002) Journal of Paediatric Gastroenterology and Nutrition
Colorectal inflammation is well predicted by fecal calprotectin in children with gastrointestinal symptoms

Fecal calprotectin can be used to select patients who should undergo diagnostic colonoscopy for investigation of colorectal inflammation, including inflammatory bowel disease.

 Fagerberg, et al. (2005) Journal of Paediatric Gastroenterology and Nutrition
Time-to-reach Target Calprotectin Level in Newly Diagnosed Patients With Inflammatory Bowel Disease

The findings of this prospective registry suggest that a quick response to conventional therapy predicts a favorable disease course in new-onset paediatric CD, but not in UC. The concept “time-to-reach target calprotectin level” rationalizes the indefinite term “response to treatment” and is well suited for studying treatment effectiveness in real-world practices.

Haisma, et al. (2019) Journal of Pediatric Gastroenterology and Nutrition
Combined Use of Noninvasive Tests is Useful in the Initial Diagnostic Approach to a Child with Suspected Inflammatory Bowel Disease

The incorporation of noninvasive diagnostic tests into the initial diagnostic approach may avoid unnecessary invasive procedures and facilitate clinical decision-making when the diagnosis of IBD in children is initially uncertain.

Canani, et al. (2006) Journal of Paediatric Gastroenterology and Nutrition
Fecal Occult Blood and Fecal Calprotectin as Point-of-Care Markers of Intestinal Morbidity in Ugandan Children with Schistosoma mansoni Infection

Due to its lower-cost which makes its scale-up of use affordable, FOB could be immediately adopted as a monitoring tool for PC campaigns for efficacy evaluation before and after treatment.

Bustinduy, et al. (2013) PLOS Neglected Tropical Diseases
Point-of-care faecal calprotectin testing in patients with paediatric inflammatory bowel disease during the COVID-19 pandemic

Home calprotectin tests were useful in guiding clinical management during a time when laboratory testing was less available. They may offer benefits as part of routine paediatric IBD monitoring to help target appointments and reduce unnecessary hospital attendances in the future.

Jere, et al. (2021) BMJ Open Gastroenterology Volume 8, Issue 1
Consecutive fecal calprotectin measurements for predicting relapse in pediatric Crohn’s disease patients

This prospective longitudinal pediatric study is the first to demonstrate that routine serial FC measurements are an independent valuable predictor of symptomatic relapse. Moreover, FC elevation was noted up to 3 months prior to the appearance of symptomatic relapse. Consequently, implementing a 3-monthly test to treat FC monitoring strategy would allow clinicians to make timely therapeutic adjustments in advance of disease relapse”. Uses BÜHLMANN fCAL® ELISA.

Foster, et al. (2019) World Journal Gastroenterology
Performance of blood tests in diagnosis of inflammatory bowel disease in a specialist clinic

Haemoglobin and platelet count provide a useful screening test combination for patients with suspected IBD. These tests are not completely reliable however. If clinical suspicion is high further investigations are required.

Cabrera-Abreu, et al. (2004) Archive of Disease in Childhood
Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease

Based on high FCal, the majority of children had treatment escalation that resulted in clinical improvement. FCal measurements were useful and reliable in decision-making and clinical care of children with IBD.

El-Matary, et al. (2017) Frontiers in Paediatrics
Fecal calprotectin is a good biomarker of mucosal healing in monitoring of children with IBD

FC is a good biomarker of mucosal healing in monitoring of children with IBD. Values below 54 μg/g enable to select 77% patients with full mucosal healing.

 Szczepański et al. (2014) Postępy Nauk Medycznych
Rapid test for fecal calprotectin levels in children with Crohn's disease

Using a cutoff of 100 μg/g for normal values, the percentage agreement between the 2 tests was 87%. The optimal cutoff values to guide clinical decisions in the therapy of inflammatory bowel disease have yet to be determined.

 Kolho et al. (2012) Journal of Paediatric Gastroenterology and Nutrition
Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn's disease

These guidelines are intended to give practical (whenever possible evidence-based) answers to (pediatric) gastroenterologists who take care of children and adolescents with CD; they are not meant to be a rule or legal standard, since many different clinical scenario exist requiring treatment strategies not covered by or different from these guidelines.

 Ruemmele et al. 2014. Journal of Crohn’s and Colitis
The use of faecal calprotectin in paediatric Inflammatory Bowel Disease

FC is a valuable test for excluding IBD in patients who present with abdominal pain and diarrhoea. When the test is used in these ways patients avoid an invasive procedure and the hospital is saved the cost of the endoscopy.

 O’Gorman et al. (2013) Archives of Diseases in Childhood
Serial fecal calprotectin changes in children with Crohn's disease on treatment with exclusive enteral nutrition

In this pilot study calprotectin decreased in patients who achieved clinical remission and may be useful to predict response to treatment.

 Gerasimidis et al. (2011) Journal of Clinical Gastroenterology
Comparison of Fecal Calprotectin Methods for Predicting Relapse of Pediatric Inflammatory Bowel Disease
High faecal calprotectin concentrations in newborn infants

Compared with healthy adults, newborns have high calprotectin concentrations in the first days of life. There is no obvious influence of the mode of feeding.

Campeotto, et al. (2003) Archive of Disease in Childhood
Dynamic Change of Fecal Calprotectin in Very Low Birth Weight Infants during the First Month of Life

FC levels may be a marker for early diagnosis and resolution of gastrointestinal illnesses in VLBW infants. Its utility for early diagnosis and assessment of resolution of NEC should be studied in a larger cohort of VLBW infants.

 Yang, et al. (2008) Neonatology
Fecal calprotectin in term and preterm neonates

Compared with adults and children, healthy full-term and preterm neonates have high calprotectin levels. The measurement of calprotectin levels in faeces can be a promising noninvasive clinical screening test for intestinal distress in neonates.

Kapel et al. (2010) Journal of Paediatric Gastroenterology and Nutrition
Faecal calprotectin during treatment of severe infantile colic Lactobacillus reuteri DSM 17938: A Randomized, Double-Blind, Placebo-Controlled Trial

The administration of L. reuteri DSM 17938 significantly decreases crying time and fecal calprotectin level. Colicky infants have significantly higher calprotectin levels than healthy controls. Finally, fecal calprotectin assay after probiotic treatment with L. reuteri DSM 17938 can be used to predict sustained clinical response and monitor gut health in infants.

 Savino et al. (2015) Paediatrics
Faecal calprotectin excretion in preterm infants during the neonatal period

During the first weeks of life, the high f-calprotectin values observed in preterm infants could be linked to the gut bacterial establishment.

 Rouge et al. (2010) PLOS One
Faecal calprotectin concentration in healthy children aged 1-18 months

The FC levels of children aged 1-18 months exhibit a downward trend with increasing age and are greater than the normal levels observed in healthy adults. In healthy children aged <6 months, FC levels are high. In children aged 6-18 months, FC concentrations are relatively low but are still higher than those of children aged >4 years.

 Li et al. (2015) PLOS One
Fecal calprotectin: cutoff values for identifying intestinal distress in preterm infants

A total of 126 infants born at a median gestational age of 33 weeks (range 25.7–35 weeks) were enrolled. Samples (n = 312) were collected weekly from the end of the first week of life until the end of the first month and if any gastrointestinal event occurred.

 Campeotto et al. (2009) Journal of Pediatric Gastroenterology and Nutrition
Fecal calprotectin determination in preterm neonates: evaluation of two methods

FC values found in this preliminary cohort of preterm neonates have been similar to those reported in the literature. The finding of a good correlation between the two techniques suggests the potential clinical usefulness of QuantumBlue at this age group (after validation).

 Gonçalves et al. (2011) Paediatric Research
Efficacy and safety of adalimumab in the treatment of Crohn's disease in children

ADA has been shown to be effective in children with moderate-to-severe CD. Treatment benefits  should be weighed against side effects. Multicenter longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment

 Navas-Lopez et al. (2013) Revista Española de Enfermedades Digestivas
Infliximab in paediatric inflammatory bowel disease rapidly decreases fecal calprotectin levels

When treated with infliximab, fecal calprotectin levels reflecting intestinal inflammation normalized rapidly in one third of pediatric patients suggesting complete mucosal healing.

 Hämäläinen, et al. (2011) World Journal of Gastroenterology
Rapid Fecal Calprotectin (FC) analysis: point of care testing for diagnosing early necrotizing enterocolitis

We present the first data showing that rapid assay FC levels are potentially useful in the bedside diagnosis of NEC.

 Bin-Nun et al. (2015) American Journal of Perinatology
SIGNEC U.K. and the Second International Conference on Necrotising Enterocolitis

While researchers grapple with the various avenues for prevention, early diagnosis and treatment of NEC,  parallel efforts are required to improve practice based on current evidence and to precisely delineate the intermediate and long-term impact of NEC.

 Khashu et al. (2013) Stansted News Limited 2015, Infant Supplement
Incidence and Timing of Presentation of Necrotizing Enterocolitis in Preterm Infants

Among infants <33 weeks’ gestation, NEC appears to present at mean age of 7 days in more mature infants, whereas onset of NEC is delayed to 32 days of age in smaller, lower GA infants. Further studies are required to understand the etiology of this disease process.

 Yee et al. (2011) Pediatrics
Fecal calprotectin concentration in neonatal necrotizing enterocolitis

Fecal calprotectin levels were significantly increased in premature infants with NEC. The fecal calprotectin test is a non-invasive, easy, and useful tool for the diagnosis of NEC.

 Yoon et al. (2012) Korean Journal of Pediatrics
SIGNEC U.K. and the First International Conference on Necrotising Enterocolitis

The SIGNEC U.K. conference represents an important first-step in providing an international platform for a focused discussion on NEC.

 Khashu et al. (2013) Stansted News Limited 2013, Infant Supplement
Mapping the New World of Necrotizing Enterocolitis (NEC): Review and Opinion

The separation of NEC from SIP (Gordon’s classification) and the subsequent reduction of NEC into subgroups (NEC reductionism) together represent an improved operational framework for more accurately assessing NEC incidence and origin.

 Gordon et al. (2013). European Journal of Neonatal Research
Necrotising Enterocolitis

An overview of; clinical presentation, prevention, staging, management, treatments, complications and prognosis, along with further reading.

Draper et al. (2011) PatientPlus Online
Fecal calprotectin levels are increased in infants with necrotizing enterocolitis

Fecal calprotectin increases in infants with NEC and serial measurements may be useful as a noninvasive prognostic marker for progression of disease

 Aydemir et al. (2012) Journal of Maternity, fetal and neonatal medicine