Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

NCT01789294 | Unknown Phase 4 DMC

• 1 other identifier: ped-LNH
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal LNH

Keywords

lymphoid nodular hyperplasia; food allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• predictive factors

  8 weeks

Study Arms (3)

Mesalamine

EXPERIMENTAL

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

Observation

NO INTERVENTION

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

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

Behavioral: DIET

Interventions

Mesalamine DRUG

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.

Mesalamine

DIET BEHAVIORAL

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.

DIET

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
• the assumption of any dietetic or therapy since the clinical onset.

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

Departments of Pediatrics, Sapienza - University of Rome

Rome, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Mesalamine; Diet

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Giovanni Di Nardo, MD

CONTACT

+390649979326; giovanni.dinardo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 12, 2013
• Study Start: November 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 12, 2013

Record last verified: 2008-11

Locations

IT (1)