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) measurementChange 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
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