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
|Condition or disease||Intervention/treatment||Phase|
|Intestinal LNH||Drug: Mesalamine Behavioral: DIET||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|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|
A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects
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.
Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists
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.
- 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.
- 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
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
|Contact: Giovanni Di Nardo, MDfirstname.lastname@example.org|
|Departments of Pediatrics, Sapienza - University of Rome||Recruiting|
|Rome, Italy, 00161|
|Contact: Giovanni Di Nardo, MD +390649979326 email@example.com|