Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
PediaMed Pharmaceuticals |
---|---|
Information provided by: | PediaMed Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00110708 |
The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in children with autism.
Condition | Intervention | Phase |
---|---|---|
Autism Autistic Disorder Child Development Disorders, Pervasive Gastrointestinal Diseases Signs and Symptoms, Digestive |
Drug: Oralgam (human immunoglobulin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled Phase II Trial Evaluating Safety and Efficacy of Oral Human Immunoglobulin in the Treatment of Gastrointestinal Dysfunction Associated With Autistic Disorder in Pediatric Patients From 2 to 18 Years of Age |
Estimated Enrollment: | 120 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | June 2006 |
Autistic GI Dysfunction (AGID) is a term that describes a constellation of GI signs and symptoms often found in children with autistic disorder, including abdominal pain, constipation, chronic diarrhea, alternating constipation and diarrhea, gaseousness, bloating, and reflux.
The objective of this study is to assess the potential efficacy of oral immunoglobulin in reducing a wide range of GI symptoms in children and adolescents diagnosed with autistic disorder.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Protocol 004 |
Study First Received: | May 12, 2005 |
Last Updated: | February 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00110708 |
Health Authority: | United States: Food and Drug Administration |
autism gastrointestinal dysfunction autistic disorder diarrhea constipation abdominal pain gastrointestinal problems associated with autism immune globulin immunoglobulin |
Immunoglobulins, Intravenous Intestinal Mucosa/immunology/pathology Administration, Oral Autistic Disorder/*drug therapy Child Behavior/*drug effects Constipation/drug therapy Diarrhea/drug therapy Gastrointestinal Agents/*therapeutic use |
Developmental Disabilities Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Abdominal Pain Pain Child Development Disorders, Pervasive Signs and Symptoms |
Antibodies Digestive System Diseases Immunoglobulins, Intravenous Autistic Disorder Mental Disorders Mental Disorders Diagnosed in Childhood Constipation Immunoglobulins |
Pathologic Processes Disease Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |