Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
Study Details
Study Description
Brief Summary
Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients Methods.We recruited children who undergone diagnostic colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. Chi-square test for trend was used to compare the frequency of symptoms score improvement (>1 point) among groups. The association of baseline features of patients with the clinical response was estimated by frequency analysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Lymphoid nodular hyperplasia (LNH) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. Although initially considered to be a normal, age-related variant, some authors recently suggested to regard LNH as a marker of food allergy (FA).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mesalamine A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects |
Drug: Mesalamine
A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects. Whether the drug was not well tolerated, patients were drop out. Treatment was discontinued at time 1 to look for symptom recurrence.
|
| No Intervention: Observation A close clinical observation without therapy was taken in control patients, whom parents were alerted to refer immediately if symptoms persisted or get worse. |
|
| Experimental: DIET Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists |
Behavioral: DIET
Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists. To ensure the correct adherence to diet with no nutritional impairment, a scheme of admitted foods and an appropriate calcium supplement dose were given to patients.
|
Outcome Measures
Primary Outcome Measures
- Efficacy [8 weeks]
to identify an appropriate management approach for LNH by evaluation of clinical severity and response. Clinical severity at time 0 and 1 was assessed by Pediatric Gastroenterologists blinded to allocation concealment. Basing on standardized Childhood behaviour checklists questionaire compiled by parents, symptoms were graded using a validated score of abdominal pain (from 0 to 12). Clinical response was defined as the improvement of at least 1 point in symptom scores from time 0 to 1.
Secondary Outcome Measures
- predictive factors [8 weeks]
we evaluated whether symptoms severity, site of LNH, presence of food sensitization and predisposition to atopy, should be predictive for the clinical response
Eligibility Criteria
Criteria
Inclusion Criteria:
-
isolated finding of LNH[18], defined as the demonstration of a significant cluster of lymphoid nodules (>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology;
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negative results of preliminary evaluation
Exclusion Criteria:
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diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
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the assumption of any dietetic or therapy since the clinical onset.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Departments of Pediatrics, Sapienza - University of Rome | Rome | Italy | 00161 |
Sponsors and Collaborators
- Azienda Policlinico Umberto I
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ped-LNH