Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Azienda Policlinico Umberto I

Status and phase: Unknown; Phase 4

Conditions: Intestinal LNH

Treatments: Drug: Mesalamine; Behavioral: DIET

Study type: Interventional

Funder types: Other

Identifiers

NCT01789294

ped-LNH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 270 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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270 participants in 3 patient groups

Mesalamine

Experimental group

Description:

A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects

Treatment:

Drug: Mesalamine

Observation

No Intervention group

Description:

A close clinical observation without therapy was taken in control patients, whom parents were alerted to refer immediately if symptoms persisted or get worse.

DIET

Experimental group

Description:

Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists

Treatment:

Behavioral: DIET