E-Healthcare for Celiac Disease-A Multicenter Randomized Controlled Trial.

OBJECTIVE: To evaluate the (cost-)effectiveness of online consultations in follow-up of patients with celiac disease (CD). STUDY DESIGN: Multicenter randomized, controlled trial involving 304 patients aged ≤25 years with CD for ≥1 year, randomized to an online (n = 156) or outpatient consultation (n = 148). An online consultation included questionnaires for symptom and growth measurement. Antitransglutaminase-type-2 antibodies were determined using a point-of-care (POC) test. Controls had a traditional consultation with antitransglutaminase-type-2 antibodies testing in laboratories. Both groups completed questionnaires concerning CD-specific health-related quality of life (HRQOL), gluten-free diet adherence, and patient satisfaction. Six months later, participants repeated HRQOL and patient satisfaction questionnaires and the POC test. The primary outcome was anti-transglutaminase-type-2 antibodies after 6 months, and the secondary outcomes were health problems, dietary adherence, HRQOL, patient satisfaction, and costs. RESULTS: The performance of the POC test was inferior to laboratory testing (2/156 positive POC tests vs 13/148 positive laboratory tests; P = .003). Health problems were detected significantly more frequently using online consultation. The detection of growth problems and dietary transgressions was similar. HRQOL (from 1 [good] to 5 [poor]) improved after online consultation (from 3.25 to 3.16 [P = .013] vs controls from 3.10 to 3.23; P = .810). Patient satisfaction (from 1 [low] to 10 [high]) was 7.6 (online) vs 8.0 (controls; P = .001); 58% wished to continue online consultations. Mean costs per participant during the studied period were €202 less for the online group (P < .001). CONCLUSIONS: The primary outcome could not be tested because the POC test was unreliable. Nevertheless, our results indicate that online consultations for children and young adults with CD are cost saving, increase CD-specific HRQOL, and are satisfactory for the majority. TRIAL REGISTRATION: Trialregister.nl: NTR3688.

Assessment of dietary compliance in celiac children using a standardized dietary interview.

BACKGROUND & AIMS: Compliance to a gluten free diet (GFD) in celiac disease (CD) is ideally assessed by dietary interviews, albeit time-consuming. Short dietary questionnaires have been developed for adults but not for children. Primary aim was to compare GFD compliance in celiac children, measured by a short dietary questionnaire against a dietary interview. Secondary aims were correlation between both questionnaires and celiac antibodies and identifying variables predicting noncompliance. METHODS: Between 2012 and 2014, participants in the E-health CoelKids study, completed a short dietary questionnaire and standardized dietary interview together with measurement of anti-tissue transglutaminase antibodies (TG2A). Results of the questionnaires were assigned under similar categories. Factors possibly influencing dietary compliance were recorded. Where appropriate, Pearson's Chi-square test for trend, unpaired t-test, Cohen's kappa and one-way ANOVA were used. RESULTS: 151 of 165 participating patients were studied, 66% were female. Mean age was 11.3 years (2-26, SD 5.4), mean age at CD diagnosis was 4.9 years (1-23, SD 4.0). The short questionnaire and dietary interview correlated poorly, detecting problems in dietary adherence in 14% and 52% of the patients, respectively (Cohen's kappa 0.034). Only the short questionnaire correlated with TG2A (p = 0.003). Only older age was associated with noncompliance, the mean age of completely nonadherent, adherent but committing errors, and strictly adherent patients were 15.5, 11.5 and 10.1 years, respectively (p < 0.001). CONCLUSIONS: Compared to the dietary interview, short dietary questionnaires and TG2A serology failed to detect dietary transgressions in CD children, wherein adolescents were shown to be at highest risk.

Randomized feeding intervention in infants at high risk for celiac disease.

BACKGROUND: A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled dietary-intervention study involving 944 children who were positive for HLA-DQ2 or HLA-DQ8 and had at least one first-degree relative with celiac disease. From 16 to 24 weeks of age, 475 participants received 100 mg of immunologically active gluten daily, and 469 received placebo. Anti-transglutaminase type 2 and antigliadin antibodies were periodically measured. The primary outcome was the frequency of biopsy-confirmed celiac disease at 3 years of age. RESULTS: Celiac disease was confirmed by means of biopsies in 77 children. To avoid underestimation of the frequency of celiac disease, 3 additional children who received a diagnosis of celiac disease according to the 2012 European Society for Pediatric Gastroenterology, Hepatology, and Nutrition diagnostic criteria (without having undergone biopsies) were included in the analyses (80 children; median age, 2.8 years; 59% were girls). The cumulative incidence of celiac disease among patients 3 years of age was 5.2% (95% confidence interval [CI], 3.6 to 6.8), with similar rates in the gluten group and the placebo group (5.9% [95% CI, 3.7 to 8.1] and 4.5% [95% CI, 2.5 to 6.5], respectively; hazard ratio in the gluten group, 1.23; 95% CI, 0.79 to 1.91). Rates of elevated levels of anti-transglutaminase type 2 and antigliadin antibodies were also similar in the two study groups (7.0% [95% CI, 4.7 to 9.4] in the gluten group and 5.7% [95% CI, 3.5 to 7.9] in the placebo group; hazard ratio, 1.14; 95% CI, 0.76 to 1.73). Breast-feeding, regardless of whether it was exclusive or whether it was ongoing during gluten introduction, did not significantly influence the development of celiac disease or the effect of the intervention. CONCLUSIONS: As compared with placebo, the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of celiac disease by 3 years of age in this group of high-risk children. (Funded by the European Commission and others; PreventCD Current Controlled Trials number, ISRCTN74582487.).

Food questionnaire for the assessment of gluten intake by children 1 to 4 years old.

OBJECTIVES: A food questionnaire (FQ) to assess gluten intake in infants 0 to 12 months old has been developed and validated (FQ-gluten), but an instrument to assess gluten intake in children 1 to 4 years is not available. Development and validation of such an instrument (FQ-gluten4) was the aim of the present study. METHODS: The FQ-gluten was adapted according to age-related food consumption. The results of this FQ-gluten4 were compared with the results of a 2-day food record. RESULTS: Seventy-one parents filled in both instruments. The mean amount of gluten consumption calculated from the FQ-gluten4 was comparable with that of the food record, but significant differences were found in the amount of gluten intake in 1- to 2-year-old children and in the percentage of gluten from porridge among the 1- to 3-year-olds. The Blant-Altman limits of agreement with standard deviation of 2600 mg were -5118 to 5630 mg. CONCLUSIONS: The new, short, standardized, validated, and easy-to-use FQ-gluten4 may be a useful instrument in the assessment of gluten intake in young children. Using this standardized method provides opportunity for better comparison of the results of gluten consumption in studies throughout the world. Furthermore, such an instrument can be used to quantify the gluten intake in individuals suspected to have celiac disease but in whom the diagnoses cannot be confirmed.

Dietary compliance and health-related quality of life in patients with coeliac disease.

BACKGROUND AND OBJECTIVE: Coeliac disease is treated with a lifelong gluten-free diet (GFD). The aim of our study was to investigate whether the dietary (nondietary) compliance is associated with health-related quality of life (HRQoL) of coeliac patients. METHODS: Patients from our hospital, known with coeliac disease for more than 10 years, were invited to participate in a study on possible gluten tolerance. HRQoL was assessed by the Short Form-36 health survey, symptoms by the Gastrointestinal Symptom Rating Scale and dietary compliance by a food frequency questionnaire. HRQoL of coeliac patients was compared with that of the general population. RESULTS: Fifty-three biopsy-confirmed coeliac patients were divided into three groups according to gluten consumption: GFD (n = 33), gluten transgression (<10 g gluten/day; n = 8) and normal gluten-containing diet (>10 g gluten/day; n = 12). Compared with the general population, coeliac patients scored significantly worse on general health perception but significantly better on bodily pain and limitations due to physical problems. The results of the Gastrointestinal Symptom Rating Scale and the Short Form-36 health survey were similar in all three dietary groups. CONCLUSION: Although adhering to the GFD is strictly important to prevent future complications, patients who stop following GFD do exist and patients with partial or nonadherence report similar HRQoL compared with patients with strict adherence in this group of adult coeliac patients.

Gluten tolerance in adult patients with celiac disease 20 years after diagnosis?

BACKGROUND AND OBJECTIVE: Celiac disease (CD) is believed to be a permanent intolerance to gluten. A number of patients, however, discontinue the gluten-free diet (GFD) without developing symptoms or signs. The aim of our study was to investigate whether CD patients are capable of developing tolerance to gluten. METHODS: All 77 adult patients from our hospital known to have biopsy-proven CD for more than 10 years were invited to participate. We investigated symptoms, gluten consumption, antibodies for CD and other autoimmunity, human leukocyte antigen (HLA)-typing, bone mineral density, and performed small bowel biopsies. Tolerance was defined as no immunological or histological signs of CD while consuming gluten. RESULTS: Sixty-six patients accepted participation, but after review of the diagnostic biopsies 53 were found to have true CD. Twenty-three percent of patients had a gluten-containing diet, 15% admitted gluten transgression and 62% followed the GFD. Patients on a GFD had significantly more osteoporosis. Normal small bowel mucosa was found in four of eight on gluten-containing diet and in four of four with gluten transgression. Two patients were considered to have developed tolerance to gluten. One of them was HLA-DQ2/DQ8 negative. CONCLUSION: Development of tolerance to gluten seems possible in some patients with CD. Further follow-up will show whether this tolerance is permanent or only a long-term return to latency. This feature may be associated with genetic characteristics, especially with HLA genotypes that differ from DQ2 or DQ8. More insight into the mechanisms of the development of gluten tolerance may help to distinguish those CD patients that might not require life-long GFD.

Tef in the diet of celiac patients in The Netherlands.

OBJECTIVE: Celiac disease (CD) is a multifactorial disease with a strong genetic association. It is caused by a T-cell-mediated immune response to wheat gluten. The treatment is a strict gluten-free diet (GFD). The purpose of this study was to investigate whether the naturally gluten-free cereal Eragrostis tef (tef) is associated with health problems when used by CD patients. MATERIAL AND METHODS: In March 2006, all 7990 members of the Dutch Celiac Disease Society were invited to complete a questionnaire on tef use and the development of symptoms after tef consumption. Respondents and their family members willing to participate were sent an extended questionnaire on the use of commercially available tef products and on the character of their subsequent symptoms. RESULTS: Thirty-six percent responded to the first questionnaire of whom 53% consumed tef and 15% reported complaints. For the second questionnaire, out of the 1828 participants willing to complete it, 1545 had biopsy-proven CD (median duration GFD: 6.5 years (range: 0-66.5 years)). Of these, 66% used tef (median duration 1.4 years (range: 0.1-5 years)) and 17% reported symptoms after consumption. The percentage for symptoms was significantly lower than that in patients without tef consumption reporting on their regular GFD (17% versus 61%; p = 0.0001). CONCLUSIONS: Tef is frequently used by Dutch CD patients and a wide majority can consume tef without experiencing any clinical symptoms. CD patients using tef reported a significant reduction in symptoms, possibly related to a reduction in gluten intake or to an increase in fiber intake. Hence, tef can be a valuable addition to the GFD of CD patients.

Food questionnaire for assessment of infant gluten consumption.

BACKGROUND: In light of the possibly preventive role of timing and amount of gluten in celiac disease, it would be helpful to have a questionnaire to assess the gluten intake in infants. AIMS: Development and validation of a food questionnaire to assess gluten consumption in healthy infants aged 0-12 months (FQ-gluten). METHODS: A food frequency questionnaire, previously developed for the Generation R study, was adapted for the assessment of gluten intake. The results of a 2-day food record (FR) were compared with the results of this FQ-gluten. RESULTS: Eighty-seven parents filled in the FR and the FQ-gluten. The number of children who consume gluten and who are breast-fed is higher, reported in the FQ-gluten. The amount of gluten is comparable from the age of 3 up to 10 months, but at 11 and 12 months a higher gluten intake is reported using the FR, probably due to a larger variety of food products not detectable by the FQ-gluten. However, there is a high agreement in the food groups (Cohens' kappa=0.6-0.8). CONCLUSIONS: This new, short, standardized, validated and easy to use FQ-gluten may be a useful instrument to assess gluten intake in infants, both at the individual and at the population level. The use of this method by investigators in other countries provides the opportunity for a better comparison of the results of gluten consumption in (co-operative) studies throughout different countries.

Nutritional management of the gluten-free diet in young people with celiac disease in The Netherlands.

BACKGROUND: For young people with celiac disease, adherence to the gluten-free diet may be difficult to achieve and gluten restriction may lead to insufficient nutrient intake and unbalanced food intake resulting in overweight. In The Netherlands, no nutritional information is available. Therefore, we evaluated the nutritional management and nutritional state in young celiac patients. METHODS: The Dutch Celiac Society invited all its members aged 12 to 25 years to complete a food record and a questionnaire. Nutrient intakes were compared with the recommendations and the intake in the general population. Total immunoglobin A, endomysial antibody, tissue transglutaminase and IgA gliadin were determined, and height and weight were assessed. RESULTS: Strict dietary compliance was reported by 75%. The fiber and iron intakes were significantly lower, and the saturated fat intake significantly higher than recommended but comparable with the general population. Most of the patients (61%) found the diet easy to follow. Regular medical controls were reported by 86% but regular dietary controls by only 7% of the patients. Mean and SD scores for height and body mass index were -0.3 +/- 1.1 and -0.3 +/- 0.8, respectively. CONCLUSIONS: The dietary compliance in this group is high, the nutritional state is adequate, but the nutrient intake is not. Better medical and dietary support is necessary to prevent long-term complications and to achieve an ongoing satisfying management in this group of young patients with a chronic disorder.