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Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Primary Purpose

Intestinal LNH

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Mesalamine
DIET
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal LNH focused on measuring lymphoid nodular hyperplasia, food allergy

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Departments of Pediatrics, Sapienza - University of RomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Mesalamine

Observation

DIET

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2013
Last Updated
February 8, 2013
Sponsor
Azienda Policlinico Umberto I
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1. Study Identification

Unique Protocol Identification Number
NCT01789294
Brief Title
Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
Official Title
CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal LNH
Keywords
lymphoid nodular hyperplasia, food allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesalamine
Arm Type
Experimental
Arm Description
A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects
Arm Title
Observation
Arm Type
No Intervention
Arm 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.
Arm Title
DIET
Arm Type
Experimental
Arm Description
Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DIET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
predictive factors
Description
we evaluated whether symptoms severity, site of LNH, presence of food sensitization and predisposition to atopy, should be predictive for the clinical response
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; negative results of preliminary evaluation Exclusion Criteria: diagnosis of concomitant inflammatory, rheumatic or infectious disease, and the assumption of any dietetic or therapy since the clinical onset.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Di Nardo, MD
Phone
+390649979326
Email
giovanni.dinardo@uniroma1.it
Facility Information:
Facility Name
Departments of Pediatrics, Sapienza - University of Rome
City
Rome
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Di Nardo, MD
Phone
+390649979326
Email
giovanni.dinardo@uniroma1.it

12. IPD Sharing Statement

Learn more about this trial

Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

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