Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Phase 4

• Conditions: Intestinal LNH
• Interventions: Behavioral: DIET; Drug: Mesalamine

• Registration Number: NCT01789294
• Lead Sponsor: Azienda Policlinico Umberto I

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.

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 Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Primary Completion: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-08
• Last Update Submitted: 2013-02-08
• Study First Posted: 2013-02-12
• Last Update Posted: 2013-02-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. 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;
2. negative results of preliminary evaluation

Exclusion Criteria

1. diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
2. the assumption of any dietetic or therapy since the clinical onset.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DIET	DIET	Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists
Mesalamine	Mesalamine	A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Departments of Pediatrics, Sapienza - University of Rome; 🇮🇹 Rome, Italy