Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Intestinal LNH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01789294
• Other study ID #: ped-LNH
• Status: Recruiting
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: February 8, 2013
• Start date: November 2008
• Est. completion date: March 2013

Study information

• Verified date: November 2008
• Source: Azienda Policlinico Umberto I
• Contact: Giovanni Di Nardo, MD
• Phone: +390649979326
• Email: giovanni.dinardo[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Intestinal LNH

Intervention

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.

Locations

Country	Name	City	State
Italy	Departments of Pediatrics, Sapienza - University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	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.	8 weeks	No
Secondary	predictive factors	we evaluated whether symptoms severity, site of LNH, presence of food sensitization and predisposition to atopy, should be predictive for the clinical response	8 weeks	No