EAL

CD: Gastrointestinal Outcomes (2006)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the characteristics of fasting and fed motor activity of the upper GI tract in a group of children with active celiac disease, to outline upper gut motility in this condition.

Inclusion Criteria:

Children diagnosed with active celiac disease. Diagnosis was made according to well-established criteria and was based on histopathologic changes of small intestine mucosa with marked clinical recovery following a gluten-free period.

Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Methods not defined.

Design

Case-Control Study.

Blinding used (if applicable)

Not applicable.

Intervention (if applicable)

GI manometry in fed and fasting states.

Statistical Analysis

Statistical evaluation carried out by employing nonparametric tests (Wilcoxon rank sum test). Values of p < 0.05 were chosen for rejection of null hypothesis. Results are presented as median values and ranges.

Data Collection Summary:

Timing of Measurements

Subjects underwent fasting and fed manometric recordings in gastroduodenojejunal area. 4 patients studied after gluten-free diet for 6 months. Data compared to controls.

Dependent Variables

Gastrointestinal manometry after overnight fast - fasting motility recorded for 3 - 6 hours, fed motility recorded for 90 minutes

Independent Variables

Gluten-free diet for 6 months
Fasting or fed state - fed motility based on meal of milk with biscuits or rice flour with dried meat and oil

Control Variables

Description of Actual Data Sample:

Initial N: 14 children (9 girls, 5 boys), 8 control children (4 boys, 4 girls)

Attrition (final N): See above

Age: Patients median age 5.4 years (range 1 - 13), controls median age 3.2 years (range 1 -8)

Ethnicity: Not mentioned

Other relevant demographics: Not mentioned

Anthropometrics: Controls were not matched

Location: Italy

Summary of Results:

Other Findings

As compared with controls, celiac disease patients showed a shorter duration of activity fronts (2.08 min vs 5.32 min, p < 0.01) and a significant reduction of the postprandial antral motility index (138 vs 832, p < 0.01).

Furthermore, >90% of the patients displayed marked fasting and/or fed abnormalities, suggesting a neuropathic disorder.

Gut dysmotilities disappeared in the 4 subjects reassessed after gluten-free diet; these patients showed almost complete restoration of the normal fasting and fed patterns along with considerable clinical and laboratory improvement.

Author Conclusion:

In conclusion, we have demonstrated that children with active celiac disease exhibit marked changes of fasting and fed upper GI motility. Active celiac disease should always be suspected in children presenting with symptoms of gut dysmotility, particularly when growth failure and serum biochemical data suggesting malnutrition and/or malabsorption are present. These findings are particularly important in light of the possibility of complete normalization of the pseudoobstructive symptoms and motor abnormalities by a proper diet. Future studies are warranted to investigate whether different patterns of dysmotility underlie different inflammatory conditions of the gut.

Funding Source:

University/Hospital:

Universita degli Studi di Napoli; Patologia e Farmacologia; Universita degli Studi di Perugia (Italy); University of North Carolina at Chapel Hill

Reviewer Comments:

Small sample size - only 4 subjects reassessed after gluten-free diet. Inclusion/exclusion criteria and recruitment methods not well defined. Controls were not matched.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	???
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		N/A
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	N/A
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	???
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes