Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa|
- Binge Frequency [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]Binge frequency wass assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.
- Gastric Emptying Rate [ Time Frame: Measured at Week 7 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Subjects with Bulimia Nervosa will take erythromycin.
Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks
Placebo Comparator: Placebo
Participants will take matched placebo.
Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Other Name: inactive substance
Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Although there is significant existing knowledge about the characteristics and treatment of BN, more information is needed about gastrointestinal (GI) function and its effect on binge eating behavior. This study will determine the effectiveness of the antibiotic erythromycin in enhancing GI function and decreasing the frequency of binge eating in people with BN.
Participants in this 8-week, double-blind study will first undergo gastric emptying and GI hormone release testing for 1 day. Within 1 week of completing these pre-treatment tests, participants will be randomly assigned to receive either erythromycin or placebo for 6 weeks. Upon medication assignment, participants will meet with a psychiatrist to receive their assigned medication. Participants will receive medication at weekly study visits. Medication dosage will be increased if symptoms do not improve, or decreased if adverse medication side effects are reported. A final day of gastric emptying and GI hormone release testing, as well as routine blood tests, will take place in Week 7, after 6 weeks of medication treatment. Participants' weight will be measured at Weeks 1, 4, and 7. Participants will also receive an EKG 1 week after each upward dosage adjustment. Patients will be informed of their medication assignment at the Week 7 study visit, and will be referred to a non-study clinician for further treatment.
For information on related studies, please see NCT00308776 and NCT00307190.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304187
|United States, New York|
|Eating Disorders Clinic, New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||B. T. Walsh, MD||New York State Psychiatric Institute at Columbia University Medical Center|