Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

A

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

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

Trial contacts and locations

1

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Central trial contact

Giovanni Di Nardo, MD

Data sourced from clinicaltrials.gov

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