Clinical Trial: Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.
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 Summary: 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).
Sponsor: Azienda Policlinico Umberto I
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: predictive factors [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Azienda Policlinico Umberto I
Dates:
Date Received: February 6, 2013
Date Started: November 2008
Date Completion: March 2013
Last Updated: February 8, 2013
Last Verified: November 2008
