NCT01789294

Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Intestinal LNH

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2013-02-12
• Last updated: 2013-02-12

Locations

1 site across 1 country: Italy