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Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

NCT00110708 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2006-02-22

No results posted yet for this study

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.

Conditions

  • Autism
  • Autistic Disorder
  • Child Development Disorders, Pervasive
  • Gastrointestinal Diseases
  • Signs and Symptoms, Digestive

Interventions

DRUG

Oralgam (human immunoglobulin)

Sponsors & Collaborators

  • PediaMed Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00110708 on ClinicalTrials.gov