Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

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

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.

Study Overview

• Status: Unknown
• Conditions: Intestinal LNH
• Intervention / Treatment: Drug: Mesalamine; Behavioral: DIET

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 Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Recruiting
    • Departments of Pediatrics, Sapienza - University of Rome
    • Contact: Giovanni Di Nardo, MD; Phone Number: +390649979326; Email: giovanni.dinardo@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesalamine; A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects	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.
No Intervention: Observation; A close clinical observation without therapy was taken in control patients, whom parents were alerted to refer immediately if symptoms persisted or get worse.
Experimental: DIET; Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Policlinico Umberto I

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 8, 2013
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: food allergy; lymphoid nodular hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: ped-LNH