Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa
Condition: Bulimia Nervosa; Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of the antibiotic erythromycin in enhancing
      gastrointestinal function and decreasing the frequency of binge eating in people with bulimia
      nervosa.
    

Detailed description: 
      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.
    

Intervention name(s): Erythromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks; Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Other intervention name(s): E-mycin; Eryc; Ery-tab; inactive substance
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binge-Eating Disorder