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Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

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ClinicalTrials.gov Identifier: NCT01789294
Recruitment Status : Unknown
Verified November 2008 by Giovanni Di Nardo, Azienda Policlinico Umberto I.
Recruitment status was:  Recruiting
First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Giovanni Di Nardo, Azienda Policlinico Umberto I

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.

Condition or disease Intervention/treatment Phase
Intestinal LNH Drug: Mesalamine Behavioral: DIET Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.
Study Start Date : November 2008
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : March 2013


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.




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 8 weeks ]

    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 :
  1. predictive factors [ Time Frame: 8 weeks ]
    we evaluated whether symptoms severity, site of LNH, presence of food sensitization and predisposition to atopy, should be predictive for the clinical response



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789294


Contacts
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Contact: Giovanni Di Nardo, MD +390649979326 giovanni.dinardo@uniroma1.it

Locations
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Italy
Departments of Pediatrics, Sapienza - University of Rome Recruiting
Rome, Italy, 00161
Contact: Giovanni Di Nardo, MD    +390649979326    giovanni.dinardo@uniroma1.it   
Sponsors and Collaborators
Azienda Policlinico Umberto I

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Responsible Party: Giovanni Di Nardo, MD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT01789294    
Other Study ID Numbers: ped-LNH
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: November 2008
Keywords provided by Giovanni Di Nardo, Azienda Policlinico Umberto I:
lymphoid nodular hyperplasia
food allergy
Additional relevant MeSH terms:
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Hyperplasia
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents