Efficacy of Open Label Placebo in Children With FGIDs

Inclusion Criteria

• •1. Age 8 to 21 years.
• •2. Diagnosis of functional abdominal pain, irritable bowel syndrome or functional dyspepsia made by a pediatric gastroenterologist according to Rome III Criteria.
• •3. Mean daily intensity of pain of 25 mm in the week prior to the initiation of the study, based on the Visual Analogue Scale
• •4. Children will not be excluded if they are adhering to any specific diet. Children will be asked to report any specific established diet prior to the study or dietary modifications that could have been made during the course of the study.
• •5. Normal laboratory tests including complete blood count, erythrocyte sedimentation rate, albumin, serum amylase, lipase, liver enzymes, urine analysis, stool examination for occult blood and ova and parasites one month prior the initiation of the study. Urinary culture will be obtained if the symptoms or urinalysis suggest the possibility of a urinary infection.
• •6. Normal lactose breath test or history of lack of resolution of symptoms on a lactose-free diet (2 weeks).
• •7. Patients receiving psychological treatment, hypnosis, biofeedback or guided imagery will not be excluded of the study if those were started at least one month prior to the initiation of the study and are not planned to be discontinued during the length of the trial. Patients will need to be prescribed hyoscyamine (clinically indicated) to be considered for this study, as the placebo will be in addition to their prescribed medication.
• •2. Evidence of organic gastrointestinal disease, hepatic disorders, urinary or cardiac disease.
• •3. Children below the 5th percentile for weight or height.
• •4. Hemoccult positive stools.
• +5 more criteria