Trial Outcomes & Findings for Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa (NCT NCT00304187)

Results Overview

Binge frequency was 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Measured at Week 7

Results posted on

2018-08-20

Participant Flow

Eating Disorders Research Clinic at New York State Psychiatric Institute

Participant milestones

Participant milestones
Measure	Erythromycin Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks	Placebo Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Overall Study STARTED	15	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erythromycin n=15 Participants Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks	Placebo n=14 Participants Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24 years STANDARD_DEVIATION 3 • n=5 Participants	24 years STANDARD_DEVIATION 3 • n=7 Participants	24 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 7

Population: Participants for analysis included 13 patients in the erythromycin and 13 patients in the placebo group who completed at least 5 weeks of drug treatment.

Binge frequency was 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.

Outcome measures

Outcome measures
Measure	Erythromycin n=13 Participants Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks	Placebo n=13 Participants Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Binge Frequency	10.4 Binge Episodes/Week Standard Deviation 8.7	11.3 Binge Episodes/Week Standard Deviation 10.9

PRIMARY outcome

Timeframe: Measured at Week 7

percent of meal remaining/minute

Outcome measures

Outcome measures
Measure	Erythromycin n=13 Participants Subjects with Bulimia Nervosa will take erythromycin. Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks	Placebo n=13 Participants Participants will take matched placebo. Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks
Percent of Meal Remaining/Minute	-.339 percent of meal remaining/minute Standard Error .14	-.177 percent of meal remaining/minute Standard Error .122

Adverse Events

Erythromycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Devlin

New York State Psychiatric Institute

Phone: 212-543-5748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place