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document
A double-blind , placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder . Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism . A randomized , double-blind , placebo-controlled , parallel groups , dose-ranging study of oral , human immunoglobulin ( IGOH 140 , 420 , or 840 mg/day ) was utilized with 125 children ( ages 2-17 years ) with autism and persistent GI symptoms . Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale ( validated in irritable bowel syndrome studies ) , number of daily bowel movements , days of constipation , or severity of problem behaviors . IGOH was well-tolerated ; there were no serious adverse events . This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population .
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Intervention_Control
placebo-controlled
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Intervention_Physical
oral human immunoglobulin
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Intervention_Control
placebo-controlled
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Intervention_Physical
oral , human immunoglobulin
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Intervention_Physical
IGOH
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Outcome_Other
global improvement scale
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Outcome_Physical
irritable bowel syndrome studies ) , number of daily bowel movements , days of constipation , or severity of problem behaviors
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Outcome_Other
well-tolerated ;
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Outcome_Adverse-effects
serious adverse events .
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Participant_Condition
gastrointestinal dysfunction
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Participant_Age
children
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Participant_Condition
autistic disorder
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Participant_Sample-size
125
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Participant_Age
ages 2-17 years
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Participant_Condition
autism and persistent GI symptoms
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Participant_Age
children
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Participant_Condition
autism