Efficacy of Open Label Placebo in Children With FGIDs
Condition: Functional Abdominal Pain; Functional Dyspepsia; Irritable Bowel Syndrome; Functional Gastrointestinal Disorders
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia; Abdominal Pain
Study type: Interventional

Summary: 
      This study is aimed at investigating the efficacy of placebo for symptom relief in children
      with abdominal pain related functional gastrointestinal disorders.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo Suspension; Hyoscyamine
Intervention type(s): Other; Drug
Intervention description(s): The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.; While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily.
Intervention MeSH terms: Hyoscyamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional Pain; Abdominal Pain; Irritable Bowel Syndrome; IBS; Functional Dyspepsia; FGID; Functional Gastrointestinal Disorders