Trials / Unknown
UnknownNCT00110708
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (planned)
- Sponsor
- PediaMed Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Autism
- Autistic Disorder
- Child Development Disorders, Pervasive
- Gastrointestinal Diseases
- Signs and Symptoms, Digestive
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oralgam (human immunoglobulin) |
Timeline
- Start date
- 2005-04-01
- Completion
- 2006-06-01
- First posted
- 2005-05-13
- Last updated
- 2006-02-22
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00110708. Inclusion in this directory is not an endorsement.