Efficacy of Open Label Placebo in Children With FGIDs
Efficacy of Open Label Placebo in Children With FGIDs
This study is aimed at investigating the efficacy of placebo for symptom relief in children
 with abdominal pain related functional gastrointestinal disorders.
The purpose of this research study is to see if prescribing an open label placebo to children
 with functional gastrointestinal disorders will help improve symptoms and their overall
 quality of life. Open label means you/your child are aware you are taking liquid placebo
 drops and not an active medication. Symptoms associated with functional gastrointestinal
 disorders (FGIDs) of children and adolescents are commonly encountered symptoms in general
 pediatrics and pediatric gastroenterology. The FGIDs the investigators are studying include
 functional abdominal pain, irritable bowel syndrome, and functional dyspepsia. The liquid
 placebo drops contain no active medication.

 Recent research studies have shown improvement in gastrointestinal symptoms after taking
 liquid placebo drops in both children and adults with FGIDs. A randomized research study for
 a medication used to treat children with FGIDs showed a very significant placebo effect,
 meaning patients receiving placebo also experienced improvement in their symptoms. Randomized
 refers to the fact that subjects were randomly selected to receive either the study
 medication or placebo. A recent adult study gave adult patients a placebo and told them it
 was a placebo, and these adults also had significant symptom improvement. The goal of this
 study is to further explore using open label (or non-deceptive) placebo use to treat 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 Word-Graphic Rating Scale score.

 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.

 Exclusion Criteria:

 1. Inclusion criteria not met.

 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. Patients with diagnosis of Inflammatory Bowel Disease, hyperthyroidism, CHF, cardiac
 arrhythmias, prostatic hypertrophy, autonomic neuropathy, biliary tract disease,
 children with spastic paralysis or chronic lung disease (we will consult a
 pulmonologist concerning the inclusion of children with chronic lung disease).

 6. Patients who are taking any of the following drugs: AbobotulinumtoxinA,
 Acetylcholinesterase Inhibitors (Central), Cannabinoids, OnabotulinumtoxinA, Potassium
 Chloride, Pramlintide, RimabotulinumtoxinB, Secretin. Patients receiving
 antidepressant or anticholinergic drugs will be excluded from the study. PPIs will be
 allowed as long as the patient had been on a stable dose for at least 12 weeks.

 7. Patients planning to change their diet during the time of the study will be excluded.
 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.

 8. Patients planning to start psychological treatment, hypnosis, biofeedback, or guided
 imagery during the course of the study or have started any of these within the month
 prior to consent.

 9. The participant is pregnant or is planning to become pregnant throughout the course of
 the research study