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Efficacy of Open Label Placebo in Children With FGIDs

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Functional Abdominal Pain; Functional Dyspepsia; Irritable Bowel Syndrome; Functional Gastrointestinal Disorders

Intervention: Placebo Suspension (Other); Hyoscyamine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Samuel Nurko, MD, MPH, Principal Investigator, Affiliation: Physician, Boston Children's Hospital
Joe Kossowsky, PhD, Study Director, Affiliation: Post Doctoral Fellow, Boston Children's Hospital
Miguel Saps, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital

Overall contact:
Joe Kossowsky, PhD, Phone: 617-935-4416, Email: joe.kossowsky@childrens.harvard.edu

Summary

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

Clinical Details

Official title: Evaluation of the Efficacy of Open Label Placebo in Children With FGIDs (Functional Gastrointestinal Disorders)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Satisfactory Relief of Symptoms and Overall Improvement (Patient Reported Outcome Measures)

Secondary outcome:

Catechol-O-methyl transferase (COMT) measurement

Change in Results of Functional Disability Inventory (FDI)

Change in Results of the Pediatric Quality of Life Questionnaire (PedsQoL)

Change in Results of the Gastrointestinal Pediatric Quality of Life Questionnaire (GI PedsQoL)

Change in Results of the Children's Somatization Inventory (CSI)

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.

Eligibility

Minimum age: 8 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Joe Kossowsky, PhD, Phone: 617-935-4416, Email: joe.kossowsky@childrens.harvard.edu

Boston Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Additional Information

Starting date: July 2014
Last updated: March 10, 2015

Page last updated: August 23, 2015

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